Dendreon expects to spend up to $50 million to expand its therapeutic biotechnology-processing facility in Morris Plains, N.J., the company said in a regulatory filing.

The Seattle biotech, which is seeking Food and Drug Administration (FDA) approval for its prostate-cancer immunotherapy, Provenge, has hired The Henderson Corp. to manage construction of a two-phase expansion of its Morris Plains facility.

The plant is where a patient's immune cells would be processed to increase the body's ability to fight prostate cancer, before being reinfused into the patient.

Additional quality-control laboratories, data center, training areas, infrastructure and offices are scheduled to be done by mid-December. The final phase, with additional manufacturing clean-room work stations, production-support areas, warehouse, infrastructure and offices, is to be substantially complete by late April.

Dendreon finished the initial build-out of its 158,000-square-foot facility in July 2006, before its FDA application was tabled to await additional clinical results.

Last month, Dendreon raised net proceeds of $221 million by selling nearly 12 million shares at $19.20 apiece. The company's stock fell $1.54, or 5.9 percent, to $24.54.

Millipore Opens $3.5 Million Danvers, MA, Biomanufacturing Facility

Millipore has opened a 33,000-square-foot biomanufacturing facility within its Cherry Hill Corporate Center building in Danvers, Mass., that will focus on manufacturing components of Millipore’s Mobius single-use disposable products, including components of the new Mobius FlexReady Solutions.

The facility will employ 120 people by year's end, and will share space with the Billerica-based company's "bioscience" division, creating a combined workforce by Dec. 31 of 268 people, Millipore told the Salem (Mass.) News.

"We are looking for assembly skills, people with attention to detail. ... It's light manufacturing work, and we have a great work force around Danvers to pick from," Chris Ross, director of manufacturing operations, told Lt. Gov. Tim Murray during a tour of the facility following the opening ceremony.

The company said its new facility contains 12,500 square feet of Class 10,000 cleanroom space, and is in the process of becoming certified to the second-highest "gold" standard of the US Green Building Council's Leadership in Energy and Environmental Design rating system. The new space can be scaled up when Millipore decides it needs additional manufacturing capacity.

The plant, which will also make components for the Mobius FlexReady Solutions line showcased at Interphex in New York in March, takes over from Millipore’s facility in California and is expected to employ a staff of 120 by the end of the year.

Christos Ross, director of the Danvers facility, told in-PharmaTechnologist that the ISO 9001-2008 certified, good manufacturing practice (GMP) standard site has been fully operational since June 9.

Ross explained that it has been designed with growth of the Mobius range in mind and is capable of distributing to manufacturers around the world.

Millipore’s VP of downstream processing Paul Chapman said that while the Mobius range grew almost 40 per cent last year and is on track to expand even more in 2009, the market is increasingly competitive.

“The current economic situation is driving the trend for more operational flexibility with single-use solutions as biopharmaceutical manufacturers strive to reduce development time, shrink costs associated with conventional manufacturing and mitigate cash burn.”

He added that the range was specifically developed to meet these needs and help biopharma firms “reduce their capital investment while answering their call for flexible manufacturing.”

Chapman also said that: “Biopharmaceuticals are the fastest growing and most attractive category in the industry,” explaining that the number of biotech drugs in development has grown from just 10 per cent on the total pipeline to nearly 25 per cent in the space of a few years.

Edward Graham-Brown, Millipore’s VP of bioprocess strategic marketing, was also enthusiastic about the biopharmaceuticals sector and its growth potential.

“It’s undeniable that new therapeutic paradigms like cell therapies, DNA vaccines, antibody fragments, will keep emerging and there will be a continued relevance for biotherapeutics in healthcare. “

He also suggested that, unlike small molecule drug manufacture which has tended to be relocated to regions where costs are lower, the complexity of making biotech medicines and investment needed made a similar shift unlikely.

Graham-Brown added that this, coupled with the industry’s efforts to reduce its manufacturing foot print in North America, should mean that demand for validated production bio processes continues to grow.

UCSF, Abbott Partner on New Pathogen Dx Lab

The University of California, San Francisco, and Abbott have partnered to launch a new research center that aims to develop diagnostic technologies for identifying viruses based on their DNA profiles.

The UCSF Viral Diagnostics and Discovery Center, located near the school’s Mission Bay, CA, campus, will use sequencing, microarrays, and other genomic technologies to characterize pathogens linked to acute and chronic human illnesses.

One of the lab's first projects will include sequencing strains of the H1N1 influenza found in patients in Mexico, the U.S. and Canada in order to study the stability of the virus is and how it changes as it spreads. The lab also is working to characterize strains of HIV from Cameroon.

In addition to sequencing, researchers at the center will also use the ViroChip microarray — developed in 2003 by UCSF's Joe DeRisi and Donald Gane to identify the virus causing Severe Acute Respiratory Syndrome — in their work.

UCSF said in a statement that the center will be "unique in offering both viral discovery as well as serving as a diagnostic resource for clinical researchers and physicians." The center will also help Abbott develop diagnostic technologies and tests for new infectious agents, particularly tools for screening blood supplies.

Abbott has been working with UCSF scientists to create the center for the last two years and last year provided its construction and equipment costs, the university said. Financial details of the partnership were not provided.

"This center could prove to be a powerful partnership for detecting more infectious agents, leading to the development of new diagnostics and therapeutics,” said John Hackett, who manages Abbott’s Virus Discovery Program, in a statement.

"In the past two decades, many human diseases, including ulcers and cervical cancer, have been discovered to be caused by bacteria or viruses," Hackett added.

The center houses an Agilent 2 µm DNA microarray scanner, Biosafety Level 2-tissue culture suite, Stratagene 3005P real-time PCR instrument, several thermocyclers, and an 8-core compute cluster. The center also has access to an Illumina Genetic Analyzer II for deep sequencing through the UCSF Center for Advanced Technology.

Vetter Packages Success with New Facility

Vetter, one of the world's leading providers of aseptically pre-filled injection systems, has completed the installation of six automatic packaging lines at the company's new packaging services facility, Vetter Secondary Packaging (VSP). The Ravensburg-based packaging facility allows Vetter to double its production capacity and provide customers with a variety of state-of-the-art packaging options from a single location.

With the capacity to handle a number of packing operations, including hand-packing, pen assembly, auto-injectors, safety devices, automatic setting of plungers, labeling, and blistering, Vetter increases its ability to serve customers by reducing their time to market. According to Vetter Managing Director, Thomas Otto, VSP fulfills one of the company's long-term strategies of meeting industry demands and future challenges. "Due to increasing economic and regulatory pressures, secondary packaging is becoming a critical issue for our customers," said Otto. "Vetter's new facility increases available capacity and enhances the range of services we can provide. In addition, it gives us the ability to perform all processes, from support in the early development phase to commercial manufacturing and even secondary packaging, at the highest quality and safety levels."

VSP features optimal conditions for pharmaceutical finishing, including a classified hygienic manufacturing area boasting the highest quality and safety standards. Designed according to the latest GMP specifications, VSP's optimal layout and design ensures the best possible protection from mix-ups and contamination and contains ventilation systems and building technology adapted to the climatic requirements of customers' active substances.

"What makes VSP particularly advanced is the complete automation of all steps on the finishing lines, including labeling, plunger installation, blistering, packing, and transport from one station to the next," said Otto. "Compared to conventional procedures, VSP allows twice the number of systems to be assembled in half the time."

VSP also includes unique finishing areas for packaging with especially strict cosmetic guidelines. Labeling and blistering are done under laminar flow and kept separate from other finishing processes, resulting in packaging systems that meet the highest requirements for cosmetic purity.

Initial planning for VSP began in mid-2006 and the building was completed in the fall of 2008. During the past several months, Vetter has installed six automatic packaging lines, completing the entire project in less than 36 months. Future expansion plans of VSP have been included in the concept and implementation of the new facility and can be carried out without interrupting operations.

OSI Mulls Expansion Move within New York, from Long Island to Westchester County

OSI Pharmaceuticals is considering a "major" relocation and expansion that would bring to New York's Westchester County research jobs the company had been expected to base at its current headquarters in Melville, NY, Long Island Business News has reported.

Kathy Galante, OSI senior director of public relations, would not comment on specifics of the relocation but did say the company had yet to reach a decision on expansion plans for any of its offices in New York, New Jersey, or Colorado, and that the company would make its decision public “in the near future.”

OSI occupies space at the Broad Hollow Bioscience Park, on Long Island's Route 110 corridor, under a lease with the state of New York that expires in 2022. “OSI has not informed Farmingdale" of any decision to terminate the lease, Kathy Coley, Farmingdale State University’s director of communications, told the newspaper.

"We have not been approached by OSI," Salvatore Carrera, Westchester's director of economic development/real estate.

RBJ: Greater Boston Lab Space Vacancy Rate Tumbles, Biomanufacturers Eye Suburbs

Greater Boston's laboratory vacancy rate tumbled during the first quarter to 9.7 percent from 14 percent, driven by expansions by life-sci giants such as Abbott, Novartis, and Genzyme, a market report from Boston commercial real estate firm Richard Barry, Joyce & Partners has concluded.

During the six months that ended March 31, tenants agreed to lease 673,000 square feet of laboratory space in greater Boston. Since mid-2003, tenants have taken up 4.4 million square feet of laboratory space, outpacing developers, who have built 3.7 million square feet, the report concluded.

Brendan Carroll, vice president of research at RBJ, told the Worcester Business Journal that his firm expects a continued positive demand trend, especially in Cambridge, Mass., which continues to dominate the region's lab market with 7.75 million square feet, compared with 3.12 million square feet in Boston and 4.4 million square feet in nearby suburbs.

One of those suburbs, Framingham, Mass., is where Genzyme is expanding a New York Avenue campus, in part by acquiring surrounding real estate since last year. “If they had been interested in looking around and seeing other options, there weren’t any,” Carroll told the newspaper.

But Genzyme and other companies have also discovered the difficulty of recruiting new employees; RBJ called the recruiting market "strained," saying that potential employees cannot easily move to greater Boston, one of the nation's costliest areas, to take life-sci jobs there without selling their homes elsewhere for less than they paid for them.

Given that, plus another consequence of the economic upheaval — an inability to finance construction of new facilities — Biotech companies “that really need the space are doing it in-house” by adding to existing campuses, Carroll told the Business Journal.

Two other signs of the economic times, according to RBJ: The availability of sublease space in greater Boston has increased during the first six months of this year, to 270,000 square feet, compared with 162,000 square feet during all of last year. Also, biotech companies are seeking to develop manufacturing operations in the suburbs — especially Devens and Worcester — using funding from the $787 billion American Recovery and Reinvestment Act, Carroll told the newspaper.

Medical Device Maker Greatbatch Opens New Clarence, NY, HQ/Research Center

Medical device manufacturer Greatbatch has opened a 123,000-square-foot headquarters and research center in the Buffalo, NY, suburb of Clarence, NY, in the latest chapter of an expansion effort that has brought about 60 new research and engineering jobs to the region since 2006.

About 260 employees are based at the new facility, which includes a $10 million, 40,000-square-foot laboratory that occupies almost a third of the Wehrle Drive headquarters and research center. Thomas Hook, Greatbatch president and CEO, declined to disclose the total cost of the facility, except to say it was “tens of millions of dollars,” but lower than the $30 million Greatbatch spent to build facilities in Alden, NY, and Massachusetts.

“These are really the perfect jobs for Clarence.” said David Hartzell, the chairman of the Clarence Industrial Development Agency, which provided tax breaks for the new Greatbatch HQ. “We know we’ll never attract the next General Motors stamping plant."

Even before the auto industry shriveled, the region lost jobs following the decline of the local steel industry from the late 1970s through the early '80s.

Greatbatch said it attributed its growth to increased research spending — set for about $48 million this year, up 17 percent from 2008, accounting for 8 percent of sales; its stepped-up pursuit of patents, and its willingness to pay toward the education costs of employees and their families. Greatbatch pays the full education costs of employees with 10 or more years at the company; higher education costs equal to 10 percent for each year of employment if they were hired before 2003 but have less than 10 years; and an amount equal to tuition for a local state university if they were hired after 2003.

The new facility will house executive offices and allow Greatbatch to centralize its research and development team. The company was founded by Wilson Greatbatch as a medical battery manufacturer, but lately it has spun off into the technology solutions sector.

Clinical Trials Solutions Company C-TASC Relocates HQ from Baltimore to Owings Mills, MD

Clinical Trials & Surveys, a clinical trials management software and professional services company also known as C-TASC, has relocated its corporate headquarters within Maryland, from Baltimore to its suburb of Owings Mills. C-TASC now occupies 17,000 square feet of office space at 10065 Red Run Boulevard — more than twice the size of its previous facility.

In a statement, the 40-person C-TASC said it needed to relocate to accommodate the addition of more than 10 full-time employees within the last year, as well as plans to continue to grow to at least 60 employees by February 2010.

The company said its job growth "is a result of the increased demand for C-TASC’s clinical trials services and technologies" — especially its Web-based data management application suite StudyCTMS — after the company won numerous new contracts to coordinate multi-center clinical trials, including its current work with the National Institutes of Child Health and Human Services, New York University, Johns Hopkins University School of Medicine, and the Food and Drug Administration.

“After evaluating many different sites, Owings Mills provided us with the best location to fit our current needs while leaving us room to continue to grow comfortably throughout 2009 and beyond," Bruce Thompson, C-TASC's president, said in the statement.

Velesco Pharmaceutical Services Opens Manufacturing Plant, Office in Kalamazoo; Labs Move to Plymouth, Mich.

Velesco Pharmaceutical Services — a provider of analytical method development, drug formulation, stability testing and consulting services to biotech and pharmaceutical companies —announced it has opened a manufacturing plant and office in Kalamazoo, Mich., and has moved its Ann Arbor laboratories to the Michigan Life Science and Innovation Center in Plymouth, Mich.

Velesco's 10,000 square foot office and manufacturing plant is located at the Kalamazoo Commerce Center. The plant will manufacture non-sterile CGMP clinical trial supplies for pharmaceutical companies in early-stage clinical trials.

The move will allow Velesco to reuse the space being vacated to accommodate the growth of its analytical and drug formulation laboratory services.

Velesco has promised state officials that its Kalamazoo expansion and Plymouth relocation — which carry a combined cost of $2 million — to create up to 35 jobs by 2014. In return, the company has been awarded a $431,536, seven-year state High Tech Mega tax credit by the Michigan Economic Growth Authority.

Velesco was launched in 2007, one of dozens of life sciences startup companies formed in the years since Pfizer's 2003 layoff of 1,200 professionals, in a consolidation move following its acquisition of Pharmacia.

Downtown Durham Wins One from RTP, as GrassRoots Biotechnology Expands

GrassRoots Biotechnology will move its offices from Research Triangle Park to the Venable Center in downtown Durham, NC — namely an 8,300-square feet space on the second floor of the Dibrell A warehouse building, the Triangle Business Journal has reported.

The relocation and expansion is designed to allow GrassRoots to grow its workforce to 25 employees.

The building is one of the former Venable Tobacco Co. buildings redeveloped into the Venable Center, a science campus owned by Scientific Properties.

Royal Society of Chemistry, GADORE Center USA, Center for Patient Interactive Research Open at Philadelphia's Science Center

The Royal Society of Chemistry and GADORE Center USA have established US offices at 3711 Market St., within Philadelphia's University City Science Center. Both are benefiting from the center's Global Soft Landing program, which assists international life-sci establishments with lab and office space, plus access to the center's full range of business support programs.

RSC is the largest organization in Europe for advancing the chemical sciences. GADORE, which stands for German-American Dialog on Renewable Energy, is a network for transatlantic exchange and dialog on renewable energy. GADORE Center USA is designed to assist German small and medium-sized businesses from the renewable energy industry that are examining their market chances in the USA, or for companies already planning to establish their own subsidiary in one or more of the 50 states.

In addition, The National Center for Patient Interactive Research has been launched at the center's Port business incubator, at 3701 Market St. CPIR said it will conduct research focusing on "unbiased" patient reported measurement of the comparative effectiveness of medical practices, both clinical processes and outcomes, with the goal of healthcare system cost savings.

Precision Stability Storage (PSS) Expanding cGMP Storage Facility in North Carolina

Precision Stability Storage (PSS) is expanding its cGMP storage facility in Wilson, North Carolina, doubling its size and adding a room for bulk powder and liquid sampling and dispensing.

The expansion will add 8500 cubic feet of stability storage space and 2500 cubic feet of sample storage, which will be in compliance with current good manufacturing practices (cGMP).

PSS has undertaken the expansion to increase its temperature and humidity controlled storage capacity, logistical support and sample data management.

Ken Edwards, director of business development, said: “The size and variety of our walk-in stability chambers, allows us to meet customer demands for storage for the most far-reaching clinical studies and commercial products."

Wing of University of Colorado's $179.8 Million Biotechnology Building an Empty Shell

A wing of the University of Colorado's planned $179.8 million biotechnology building will likely remain an empty shell until enough funding is available to complete it.

A subcommittee of CU regents gave preliminary approval during a meeting to a new plan that splits construction of the biotechnology building into two projects, a modification that comes about two months before the anticipated groundbreaking. The revised plan still needs approval from the full board, which will meet in Colorado Springs, said CU system spokesman Ken McConnellogue.

Frank Bruno, the Boulder campus's vice chancellor for administration, told CU leaders that the campus wants to split the construction into two projects so the university can proceed with the project despite the absence of state funding.

University officials estimate that donations, federal dollars and the Boulder campus will fund the initial building for $148 million, and hope that $31.8 million will eventually come from the state to finish the building.

The first phase of the project would be about 262,000 square feet, and include an auditorium and three wings that will house labs and university departments. The second phase would be bringing a 50,240-square-foot wing for undergraduate classes and the Department of Chemical and Biological Engineering.

The biotechnology building helped bring Nobel laureate Tom Cech back to CU, and he plans to locate his lab in the new building on CU-Boulder's East Campus. The building is designed to allow researchers from labs scattered across the campus to come together to solve complex biomedical problems.

It could take up two years to construct the main building. But the document approved by CU regents Monisha Merchant and Tillie Bishop, who are on the construction subcommittee, doesn't give a concrete date on when the final wing of the building would be completed since it relies on state funding.

A design firm began work on the building in April 2008.

Kelly Fox, CU's chief financial officer, told university leaders during Monday's meeting that the state has little money available for capital construction projects.

Still, CU's Boulder campus has listed funding for the biotechnology as its top priority and will ask the state for $26.95 million in 2010-11 and $4.82 million in 2011-12.

"It's important to have our needs known by the state," Fox said.

Drug Safety Institute Launched

The Hamner Institutes for Health Sciences and the Univ. of North Carolina at Chapel Hill have announced the launch of The Institute for Drug Safety Sciences, strategically located on The Hamner's 56-acre campus in Research Triangle Park.

The Institute will be led by Paul Watkins, one of the world's leading experts in drug-induced liver injury who currently serves as the Verne S. Caviness Distinguished Professor of Medicine at UNC. As founding director for this innovative research Institute, Watkins has assembled a core group of internal scientists and academic partners to develop new global drug safety initiatives in collaboration with the bio/pharmaceutical industry, the NIH and FDA.

A major initial focus will be to develop new computational models and in vitro assays, starting with evaluating liver toxicity and expanding into cardiovascular and kidney drug side effects.

The Institute includes a 14,000-square-foot, state-of-the-art research laboratory, which was unveiled at a grand opening on June 11. The event featured a keynote from Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research, which oversees the approval and regulation of all U.S. medications.

The June 11 event built on a MOU signed by The Hamner and UNC in April 2008 and a $10M funding commitment established in September 2008. The Hamner-UNC partnership capitalizes on the scientific strengths of a leading university and an independent research institute, which are committed to accelerating advances in human therapeutics and public health.

In March 2009, scientists at the Institute for Drug Safety Sciences launched their first research initiative in the study of drug-induced liver injury by forming a partnership with Entelos, a leading Silicon Valley computational modeling company. Besides being a main cause of acute liver failure in the U.S., liver toxicity is also the major reason global regulatory agencies take action on drugs, including denying approval for drug development candidates or withdrawing drugs from the marketplace.

By creating a virtual liver model, researchers hope to predict how pharmaceutical drugs and chemical agents damage the liver. The project supports the FDA's "Critical Path Initiative," which aims to reduce the time it takes to develop and approve safe and effective medical products.

The Institute has also signed an agreement with the Shanghai Center for Disease Control to conduct a study in patients who have experienced liver toxicity as a result of taking drugs to treat tuberculosis. Knowledge from this study in China will enable the Institute to create strategies to develop safer drugs. Hamner also announced a translational research and business development partnership with China Medical City and Newsummit Biopharma to establish an Institute for International Drug Development.

Maryland County Officials Hold Firm to Impose New Fees on Two Life-Sci Developments

The Planning Board of Maryland's Montgomery County told two prospective developers of large mixed-use projects that it would not retreat from imposing new fees or "exactions" as conditions of approval, absent more details about development costs and economic benefits associated with the plans.

At a morning-long work session the board members in favor of the new exactions said they were unconvinced by an economic analysis submitted by consultant RCLCO for Johns Hopkins University and local developer Percontee.

In a 15-page analysis of the so-called Gaithersburg West project, which seeks to build a combined 8 million square feet of new life-sciences space, RCLCO concluded that the increased exactions would hurt their projects by reducing land values, raising rents, and driving away prospective life-sci employers.

"The vision shared by JHU and Percontee to create internationally renowned epicenters for the advancement of the life sciences and applied technologies in the 21st Century and beyond — and the valuable opportunities they represent to Montgomery County and the state of Maryland — will likely not be realized if Montgomery County were to elect to treat these unique life sciences, mixed use communities in the same fashion as other, more conventional, mixed use developments," the report said.

Percontee, a Silver Spring, Md., developer, wants to develop more than 2 million square feet of life-sci space as part of a mixed-use project for its 185-acre property near the US Food and Drug Administration campus in White Oak. The project would also include 2,000 condominiums and townhouses, 200,000 square feet of retail space, and 50 acres of undeveloped open space.

JHU has even more ambitious plans for its 107-acre Belward Farm, a former farm deeded to the university for academic purposes. The university seeks to transform the property into a research campus with 6.5 million square feet of new R&D space — a development density it hopes will create enough critical mass to draw federal health and scientific research agencies.

However, the draft Gaithersburg West master plan being reviewed by the planning board would scale down JHU's project to a maximum of 4.5 million square feet located in buildings whose height would be capped at 143 feet. The board last month split the difference between JHU's proposal and a request by the civic group Reasonable Development, which sought to limit the Belward space to 2 million square feet.

Planning Board Chairman Royce Hanson and board member John Robinson said they were yet to be convinced that the county would generate enough new revenue from development to justify any potential rollback in exactions.

"I don't really expect the state to roll up with an armored truck and dump a lot of money in front of the county office building," Hanson said. "The question is, 'What is our return on investment if we make it?'"

At issue are plans by the county to require developers of life-sci space, as well as "general" office and retail space, to either pay into the county's Agricultural Land Preservation Fund or buy 12.5 percent of the floor area they wish to build above a 0.5 FAR, defined as the amount of square footage within a building divided by the square footage of the lot on which that building stands.

Hanson said the developers can reach the 0.5 FAR figure by "building lot termination" easements at one lot per 7,500 square feet of non-residential space, which he calculated would eliminate one building lot per 60,000 square feet of space above FAR 0.5.

The BLT exaction would cost $1.77 per square foot of space built to a floor-area ratio of 1.0, and $2.36 per square foot for denser developments built to a 1.5 FAR.

That would add between approximately 19 percent and 25 percent to the current $9.50 square-foot cost of current exactions required of lab/R&D developers, which include fees toward public transportation, public open space, and sustainability, with the denser development exacting the higher cost.

While the RCLCO analysis pegged the cost of BLTs at $212,500 per building lot easement of 7,500 square feet, an analysis of that report by county planning department staffer Jacob Sesker said the approximate cost of the BLT per easement was between $200,000 and $250,000.

What Price Shelter?

In addition, Montgomery County wants developers of new residential projects with densities of 20 or more units per acre, or with 100 or more units of any density, to pay toward a county fund designed to create "moderately priced dwelling units" for people making between 60 and 120 percent of the county's area median income.

That exaction would range from 33 cents per square foot for condo projects with a 0.5 FAR to $3.54 per square foot for condo projects built at a 1.5 FAR. Apartment developers would also be charged $1.02 per square foot for projects at 1.5 FAR.

The US Department of Housing and Urban Development said Montgomery's AMI stood at $99,000 last year. Meantime, the median price of a single-family home in the county was $358,117 in May, down nearly 13 percent from a year ago, according to the Maryland Association of realtors, but still the highest median cost of any county in the state.

Robinson defended the new exactions: "The BLT is like the sales tax, like the income tax. It's what everybody pays for quality of life."

He said he would be more willing to consider the arguments of life-sci developers if they focused more narrowly on seeking county help in reducing the steepest costs, such as infrastructure. However, he said JHU and Percontee would have to furnish more data on the projected development costs and benefits of their projects, rather than stick with their current analysis of the costs wrought by proposed as well as current exactions.

"The focus of [the RCLCO] analysis is, shall I say, questionable," Robinson said.

Sesker's review and the RCLCO analysis can be seen here along with a 38-page economic report prepared by a Washington, DC, consultant it hired, Partners for Economic Solutions, which defended the planning department's strategy of promoting life-sci growth by encouraging several mixed-use, higher-density projects near current and planned public transportation stations.

"The vision for Gaithersburg West as a higher density village could be quite effective in helping the county attract and retain knowledge workers — the key to long-term prosperity in the evolving knowledge economy," PES concluded in its report.

PES projected the county's life-sci workforce will increase by 4,200 jobs to 16,200 by 2025, due in part to the proximity of the FDA and the National Institutes of Health and to the expectation that companies will continue to seek to be near both. This increase, however, amounts to annual job growth rates of 2 percent or less each of the next 16 years.

According to the PES report, Montgomery County currently is home to 223 "bioscience" businesses and 6.65 million square feet of life-science space. Of that, 49 percent is flex space, 45 percent office space, and the remaining 6 percent industrial space.

The nine-page review of the RCLCO study by Sesker, a planner-coordinator in the planning department's vision division, defended the county's plan to add to developers' exaction costs by arguing that a rollback, even if it lowers rent for the life-sci tenants the developers hope to attract — smaller early-stage shops — would not benefit those tenants as much as other forms of economic incentives could.

"Relief from exactions is a clumsy form of economic incentive, insofar as the benefit to tenants is often indirect," Sesker wrote in his review. "Early-stage research entities can often benefit more from infusions of cash than from modestly lower rents."

Sesker also suggested that developers should look beyond the traditional approach of building more space if they want to create projects whose revenues more than exceed construction costs. "In certain situations, mix of uses can overcome the costs of building additional density."

But that is not necessarily the case for life-sciences projects like the one JHU has in mind for Belward, David McDonough, senior director of development oversight for Johns Hopkins Real Estate.

"In many cases, over time, well-executed mixed-use environments can achieve market premiums that can justify their higher construction costs; however, in a life-sciences village, these uses are ancillary and limited in relationship with the proposed life-sciences and research uses," McDonough said via e-mail. "The plan supports increased lab and research space and limits the ancillary uses."

McDonough said exactions aren't the only reason why Montgomery County's building costs are already higher than those of most neighboring areas — and why they may be pushed even higher by the time JHU is able to develop Belward.

Although its land values are higher than other Maryland locations, Montgomery County has historically been able to compete with Baltimore and other counties in the region because of its desired location adjacent to the District of Columbia and federal agencies.

"The high cost of structured parking in this currently suburban location — when coupled with more exaction — increases development costs well beyond those of nearby competitors," McDonough said.

He cited Sesker's analysis, which concluded in part: "Other incentives, such as publicly financed structured parking, might be more effective as a means to achieve the vision in the Draft [Gaithersburg West Master] Plan."

From Percontee's perspective, the exactions would hinder its development plans and signal that the county was not friendly to life-sci development, Jonathan Genn, the firm's executive vice president and general counsel, told the planning board.

Genn's comments came a few weeks after Maryland Gov. Martin O'Malley insisted, during the BIO 2009 International Convention in Atlanta, that the state's budget woes would not stop it from spending $1.3 billion on initiatives designed to grow its workforce by 2020.

"If Montgomery County sends out a message [that] we're going to be a little hostile to [life sciences development] because we think Montgomery County is so strong people will come here without making any additional effort, then the state is going to say [that] state money that could be used to incentivize the life sciences is going to be much better [and] economical to give it to Frederick County, Howard County, Anne Arundel County, and Baltimore City," Genn said.

"If we are not incentivizing the life sciences, than we increase our chances that … " Genn continued, before Hansen interrupted: "I don't think anybody is talking about not incentivizing or not wanting life sciences.

"Given the character of our population, given the character of life sciences activity that is already here, it's a natural kind of industry that we want to grow," Hansen said. "The sole question we are trying to deal with here is, 'How much should it be expected to stand on its own, and how much subsidy does the rest of the county [have] to give it for whatever it generates?'"

The work session was one in a series scheduled for board members to discuss density limits and other parameters of life-sci development called for under a draft master plan now in late stages of review for Gaithersburg West, the section of Montgomery County along the Interstate 270 corridor.

The draft master plan concludes that Montgomery County should transform Rockville's 900-acre Shady Grove Life Sciences Center campus into a live-work research hub with 20 million square feet of laboratory, office, and commercial space capable of supporting 60,000 jobs over the next 30 to 40 years. That's 55 percent above the 12.9 million square feet of new development now allowed within Gaithersburg West.

Within that total is the 1.1 million to 1.5 million square feet estimated as the total demand for space among life-sciences companies through 2025, according to an economic study conducted for the county Department of Planning by Washington, DC, consulting firm Partners for Economic Solutions. PES derived its space estimate from a projection that each year up until then, life-sci companies will seek between 70,000 and 105,000 square feet of space.

That would boost, by up to 53 percent, Montgomery County's current lab space inventory of 2.79 million square feet, according to the real estate market tracker CoStar. Since 2000, that inventory has grown by 11 percent, or 310,000 square feet, while average asking rents sought by brokers rose 53 percent to $24.03 per square foot from $15.24, triple-net.

But in a reflection of today's economy, the county's occupancy rate for lab space has slid to 80.5 percent during the first quarter of 2009 from 80.9 percent for all of 2008, and a high for the decade of 88.6 percent in 2005.

The draft master plan also calls for a shift in the land use envisioned by the county's "Life Sciences Zoning" category — from projects that develop labs, offices, office-industrial "flex" space, and educational space within separate buildings, to mixed-use projects that blend all four while also allowing for residential and retail space.

Among such projects is JHU's plan to redevelop the 107-acre Belward Farm. JHU seeks to develop there up to 6.5 million square feet of development toward a research campus with enough critical mass to draw federal health and scientific research agencies.

Last month, the planning board rejected that development concept in favor of a scaled-down "Science City" of up to 4.5 million square feet of buildings up to 143 feet high. The planning board also rejected a request by the civic group Reasonable Development that sought to limit the new construction at 2 million square feet.

"The recommended density of Belward at 1.0 FAR is not a deal breaker, it simply makes the plan marginally less competitive — but it is still competitive. The intensity and mix of uses is essential to establishing a transit-oriented life sciences center that is nationally and internationally competitive," McDonough told BRN.

At least one critic of the JHU plan said density should be less a concern for the board than the proximity of the project to an existing mass transit system, and ensuring that the mix of uses resembles a traditional city, rather than a more suburban project that would worsen area traffic because employees would commute from areas cheaper to live in than Montgomery.

Since this proposal is so far away from the core of the region, its employees could easily move farther out like many already have who commute to Tysons (Corners). If the place is suburban and car-dependent, why would they pay all that money to live there when Frederick County is also mostly car-dependent and a lot less expensive?" Cavan Wilk, a Montgomery County activist for walkable communities and mass transit, told BRN via e-mail.

"Basically, the problem is that the "Science City" is not looking like a city at all. It's looking more and more like car-dependent sprawl," Wilk said. "If the development was to be a true town, it would provide the amenities that make a town attractive like proximity, safe pedestrian environment, and a vibrant social atmosphere. A car-dependent office park with lots of parking, as the latest plans show, would provide none of those amenities. On top of that, housing prices in that area aren't exactly cheap. People pay to live there so they can commute to DC, Bethesda, and Silver Spring.

"I would be happy to advocate for the proposal if it hooked up to an existing transit connection and was planned to be a real town. As it is, I think it needs to be opposed," Wilk added.

McDonough also said Belward would complement, rather than struggle to compete with, two emerging urban-scale life-sci campuses on opposite sides of the city of Baltimore, about an hour's drive northeast of Montgomery County.

Science+Technology Set to Build 1.1 million Square Feet of Life-Sci Space

The Science+Technology Group of Cleveland developer Forest City Enterprises is set to build 1.1 million square feet of life-sci space as part of a planned multi-billion-dollar, mixed-use redevelopment of East Baltimore with Presidential Partners, a minority-business consortium of Baltimore-based developers.

One building was completed last year — the $54 million, 278,000-square-foot John G. Rangos Sr. Building, also called 855 North Wolfe St., but the national economic upheaval has pushed the project behind schedule recently.

University of Maryland, Baltimore Developing BioPark

In West Baltimore, the University of Maryland, Baltimore, is developing BioPark, a 10-acre, 1.8-million-square-foot site comprising lab and office space set among 12 buildings. To date a pair of multi-tenant buildings totaling 360,000 square feet have been completed by Baltimore-based Wexford Science + Technology.

Unlike the Baltimore campuses, JHU's McDonough said, Belward will be closer to NIH and FDA.

"With over 60 percent of the State’s biotech companies in Montgomery County, the proposed Gaithersburg West Life Sciences Vision is directed toward collaboration and applied science — converting discoveries into products, and getting these products into the market place through the FDA," he said. "Baltimore’s historic focus has been more toward basic research leading to discoveries and advances in education and health care.

"We feel these Baltimore based and Montgomery County based bioresearch clusters, all three of which include Hopkins and the University of Maryland, working collaboratively through Research Parks Maryland, result in a highly complementary regional bioscience cluster," he added.

Belward would be one of five Life Sciences Center zoning districts contemplated by the Gaithersburg West Master plan. The others are:

• LSC North, which has easy access to I-270 from Shady Grove Road and Interstate 370, also called the Sam Eig Highway.

• LSC Central, home to the J. Craig Venter Institute and Shady Grove Adventist Hospital.

• LSC South, anchored by the Universities at Shady Grove and the headquarters of Human Genome Sciences

• LSC West, anchored by the 60,000-square-foot Shady Grove Innovation Center, and the 52-acre county-owned Public Service Training Academy. The county government wants to sell or lease the PTSA property, located within the Shady Grove Life Sciences Center campus in Rockville, Md., to a developer willing to include life-sci space among a mix of uses, and who wants to relocate the academy [BRN, Aug. 11, 2008].

The master plan would allow increased development of new life-sci and all other development in stages. The stages would be pegged not to a specific timetable, but to milestones that include the completion of previous stages, redevelopment of the PTSA property, and the development of a new 13.5 mile mass-transit system known as the Corridor Cities Transitway, now being studied by the Maryland Transit Administration:

• Stage 1 — 400,000 new square feet of new non-residential development in LSC North, Center, and Belward districts. The three districts have a combined 5.5 million square feet of existing development, with another 2.7 million square feet of future development approved.

• Stage 2 — 2.8 million square feet of new commercial development in all LSC districts, in addition to the 8.6 million total square feet of development allowed under stage 1.

• Stage 3 — 1.8 million square feet of new commercial development in all LSC districts, in addition to the 11.4 million square feet allowed in stages 1 and 2.

• Stage 4 — 4.5 million square feet of new commercial development in all LSC districts, in addition to the 13.2 million square feet allowed in stages 1, 2, and 3.

The planning board at its work session exempted Shady Grove Adventist Hospital and other providers of healthcare services from the 400,000-square-foot limit of stage 1, after its lawyer, Robby Brewer of the law firm Lerch, Early & Brewer, argued that the limit could delay future expansion of the facility. The hospital is completing a four-year, $100 million expansion-renovation project that included the opening last month of a new 3,400-square-foot pediatric emergency department.

Even without the development limits contemplated in the master plan, RCLCO acknowledged in its report, neither Percontee's project, nor JHU's, are expected to get built any time soon: "The current distressed state of the economy would likely forestall development on either property in the near future."

BioLife Solutions Establishes New Internal Manufacturing Facility

BioLife Solutions has announced the completion of construction and validation of its internal GMP manufacturing facility. The company has released first production lot of its biopreservation media products made in Bothell for commercial sales.

The company had announced the transition from using a contract manufacturer to internal production in 2008, in order to reduce production costs and enable custom packaging and formulation offerings for biopreservation media products.

BioLife's 6,000-square-foot GMP production facility incorporates a uni-directional workflow design that was finalized with the input of several cleanroom consultants and members of BioLife's Quality, Scientific and Regulatory Advisory Board.

The facility consists of ISO14644 classified airlocks and rooms for product formulation, filling, final inspection and cold storage, as well as other mixed and dedicated use space, including R&D and quality control laboratories and order fulfillment space.

Mike Rice, Chairman and CEO, BioLife, said: "We're very pleased to have met our cost, schedule, and quality goals for this construction project. We now have the capacity to produce up to 12,000 liters of HypoThermosol and CryoStor biopreservation media annually, and have the ability to increase this significantly by investing in additional automation equipment. Over the coming quarters, we expect to realize volume driven cost reductions and will leverage our internal production capabilities to offer custom packaging and product variants to meet customer demand for our best-in-class biopreservation media products."

Agilent and Los Alamos Support BioLab

Agilent Technologies has announced its researchers are developing new tools for rapidly characterizing biological pathogens that could give rise to potentially deadly pandemics such as Influenza A (H1N1). This is part of a joint effort by national laboratory-, university- and private-sector institutions.

The first tool, an automated genotyping system, is a joint effort between Los Alamos National Laboratory (LANL), the Univ. of California at Los Angeles School of Public Health and Agilent. This system will be utilized in the Global Bio Lab at UCLA and will use high-throughput technology for automated global-public-health surveillance.

The automated genotyping system, built to specification by Agilent, was delivered to LANL in late-May for verification of design and capability testing. The $1.7 million BioCel Automation System was designed in collaboration by Los Alamos and UCLA researchers, and professionals at Agilent's Automation Solutions division, previously known as Velocity11.

The system will be able to automatically determine the genetic sequence of viruses such as influenza hundreds of times faster than any other method available today.

By using this system and future high-throughput tools in pandemic response mode, public-health officials will be able to rapidly and reliably determine the strain of a virus, allowing more time for mitigation or containment strategies to be employed if necessary. Moreover, these BioCel systems will be useful in research mode for monitoring animal populations for the emergence of new and potentially deadly pathogens before the pathogens are able to infect humans.

The UCLA Global Bio Lab will become part of the High Throughput Laboratory Network (HTLN). When built out, the network will provide an international and interconnected capacity that enables uniformity in testing methods -- reducing the potential for errors or confusion arising from variable testing methodologies currently used.

"As the recent outbreak of the swine flu shows, we need to do a much more extensive and thorough job of surveillance," said Tony Beugelsdijk, leader of the HTLN project at LANL. "This program will provide the world with the tools for this task."

Current genetic identification methods require lots of time and manpower. The new genotyping system features two robots and the ability to fully sequence 10,000 or more influenza viruses per year. This makes it much faster and more reliable than current methods, and reduces the amount of manpower necessary to process a large number of samples.

"This system is the next-generation tool to rapidly and accurately test and identify biological pathogens in mass quantities of samples," said Nick Roelofs, VP of Agilent Life Sciences. "Capable of performing tests 100 times faster than any current method, it will provide reliable, real-time data to the global health community. Given current health concerns about the swine flu, the system addressees an immediate and vital need in the public health arena."

Georgia Tech, Partners Plan Med Device Prototyping Center as Step in Broader Effort to Nurture Startups

Four of Georgia's top research and healthcare institutions are months away from launching the first initiative in a broader collective effort to spin out medical device companies and keep them growing in the Peachtree State — an effort that aims to address the state's longtime weakness in nurturing new life-sci startups.

Georgia Institute of Technology, Saint Joseph's Translational Research Institute, Piedmont Healthcare, and the public-private Georgia Research Alliance plan later this year to identify potential funding sources for the first of several initiatives to comprise the new Global Center for Medical Innovation.

That initiative would be a $3 million to $4 million center that would allow startups to develop prototypes of medical devices with commercialization potential, especially those focused in cardiology, orthopedics, and pediatrics. The center is anticipated to open as the first component of the GCMI, which hopes to grow long-term in Technology Enterprise Park, an 11-acre Atlanta complex affiliated with Georgia Tech.

"We would like to have it within Technology Enterprise Park. But we're going to have a location sooner than two years, which is what it would take to build a new building," said H. Wayne Hodges, vice provost for Georgia Tech's Enterprise Innovation Institute. "We need this up and running and a presence for this sooner than two years. We will probably be looking at some other alternatives that are in that park," most likely in existing space, Hodges said.

The tech park now includes a 14,175-square-foot building that houses the applied research arm of Georgia Tech, the Georgia Tech Research Institute; and a five-story, 126,760-square-foot research building that has all but been filled by three tenants — Altea Therapeutics, which occupies 49,400 square feet; CardioMems, which has 40,137 square feet; and the 37,119-square-foot US outpost of Finnish-based worldwide chemical group Kemira.

Another building opened last week — a 32,000-square-foot preclinical research facility refurbished to good laboratory practice standards by SJTRI, at a $20 million cost. That facility is designed to integrate with Saint Joseph's clinical program at its tertiary care hospital in Atlanta. "We'd like to be adjacent to [the pre-clinical facility] because what they're going to be providing there will be something that will be available [to those who] want to design and develop prototypes, but also do preclinical trials and that sort of thing," Hodges said.

"What we think we have is this all-in-one facility for medical devices that really doesn’t exist in the Southeast," Hodges added.

Plans for Technology Enterprise Park also include a five-story, 124,131-square-foot building originally set to open in 2010, but which has been postponed because of the global economic upheaval — as well as a pair of future-development building lots totaling 350,000 square feet. The buildings would all bring the tech park's maximum developable area to 600,000 square feet.

Nicolas Chronos, president of SJTRI, told BRN that his institute is "in negotiation to raise the money needed to build" the five-story building, with the goal of starting construction later this year, in partnership with the private, nonprofit University Financing Foundation. He estimated SJTRI would need $20 million to break ground, toward a $30 million cost of the facility.

"We imagine that we will come out of the ground in the next six months, but we won't have it available to use for 18 months," Chronos said in an interview at BIO 2009. "We will actually build a second facility, which is an imaging facility [with] advanced imaging, molecular imaging, cancer imaging, genomics, CT, MRI both for large and small preclinical models. But in addition, we may have toxicology capabilities, and other capabilities — including of course the prototyping center, which to date haven’t existed here in the Southeast."

SJTRI would occupy the bottom floor in the five-story building, equaling about 25,000 square feet. "We're talking to several of the other big healthcare systems in town to partner with us and take floors themselves," Chronos said. He cited one system that has expressed interest in the project, the pediatric healthcare system Children's Healthcare of Atlanta, with which it is in talks to file a physician-sponsored investigational new drug application with the FDA to use one piece of equipment developed by SJTRI.

"We're hoping it's going to be called the Atlanta heart valve," Chronos said.

He said SJTRI has experience raising money via private philanthropy to develop a translational research institute that enabled pre-clinical services at a sister hospital, Holy Cross Hospital in Fort Lauderdale, Fla. Beyond the Saint Joseph's system, he said, the nation's largest Catholic, nonprofit health system, St. Louis-based Ascension Health, has asked to partner with SJTRI, as has the Camden, NJ-based Lourdes Health System.

"We're a little bit like the hub, leveraging university and academic partners, and industry partners, and taking that across to areas of clinical expertise that exist in the community. The Holy Cross program will be more oncology focused, so we will be taking more of the cancer activities to them, whereas the Lourdes system is interested more in the cardiovascular capability," as is Mercy Hospital of Portland, Me., Chronos said.

At Technology Enterprise Park in Atlanta, Chronos said, the five-story building would result in SJTRI adding "another 30 or 40 at least" to its current staff of 70, part of between 400 and 500 people expected to work in the building when all floors are occupied.

Many of those professionals, he said, would likely be recruited from outside Georgia — as was the case with the chief scientific officer who joined SJTRI earlier this month, Jai Pal Singh, a former head of vascular therapeutics research and research advisor in the atherosclerosis-metabolic drug team of Eli Lilly.

"There will be certain types of people who don't exist here — some of the regulatory capability, some of the senior management. As far as biomedical engineering, that's fairly well covered. We have a good workforce. We probably need some senior management talent, and that's what we'll recruit," Chronos said.

The prototyping center could emerge in phases in that building, since its heavy equipment would need to be at ground-floor level, though not its GMP clean rooms, Hodges said. That building could also serve as a location for startups that have grown out of the prototype center or a business incubator planned longer-term for the GCMI; Georgia Tech has its own biomedical incubator at its on-campus "Bio Quad," in the basement of its biomedical science and technology building.

"Maybe eventually we move that over into this [building under construction], and have it all together," Hodges said.

Hodges said the GCMI is in the process of interviewing candidates to manage the center. A decision is expected in as little as three weeks from the GCMI's board of directors, which is designed to represent the center's four institutions.

"This may not be the final management. It may be a startup," with a decision to come at a later point on a permanent management, he said.

Mike Cassidy, president of the GRA, told BRN the four institutions will contribute $100,000 each toward a formal business plan: "Over the summer, we're going to be finishing that up."

That plan is expected to call for several million dollars of investment from "several large companies and investors who have interest in being a part of" the GCMI, Hodges said. He would not name the prospective companies and investors.

"We have world-class clinicians in cardiology, orthopedics, and pediatrics, and we need to take advantage of that. We have world-class faculty researchers in devices, from an engineering perspective. Putting all of that together is an awfully powerful argument," Hodges added.

A 'Burgeoning' Industry

Hodges and Cassidy spoke in an interview minutes after Georgia Gov. Sonny Perdue announced the creation of the medical innovation center from his state's pavilion at the Biotechnology International Organization's 2009 International Convention, held May 18-21 in Atlanta at the Georgia World Congress Center.

"We do believe that the Global Center for Medical Innovation at Georgia Tech is going to be the centerpiece of a burgeoning medical device and medical technology industry, not only in this region, but obviously these devices can be used worldwide," Perdue said. "We're excited about the economic opportunities this will bring to our state as well.

"By bringing together public and private resources, we're providing a strong foundation for real progress in medical devices and the medical technology industry," Perdue added.

Until now, that progress has been hard to spot in Georgia. Hodges held off saying how many med device spinouts Georgia Tech generates annually, pending a return to his office. Using another measure of med device progress — the amount of venture funding collected by companies — Georgia finished the first quarter with no medical device deals, compared with $1.05 million in three deals during the first three months of 2008, according to the quarterly MoneyTree Report produced by PricewaterhouseCoopers and the National Venture Capital Association, based on Thomson Reuters data.

The Southeast's strongest life-sci state, North Carolina, attracted a single $3.4 million medical device deal during Q1 '09, down from the sole $10 million deal recorded in the year-ago quarter. Yet those numbers were no match for those recorded by MoneyTree for the nation's top three med device states during the first quarters of 2009 and 2008:

• California: More than $210 million in 22 deals in Q1 '09, compared with $550 million in 46 deals in Q1 '08.

• Massachusetts: $42.2 million in six deals, down from 13 deals totaling $67.1 million.

• Minnesota: $33.25 million in two deals, just 7 percent below $35.9 million in four deals.

"We don’t have the advantage of longtime, well-established support networks that some of our competitors do, but certainly [GCMI and its] partnerships go a long way in helping to foster the growth of the biotechnology industry, and in particular biomedical device development within the state of Georgia," said GP (Bud) Peterson, who took office last month as president of Georgia Tech, during the announcement of GCMI at BIO 2009.

Hodges said the four institutions have spent the past two years discussing the creation and development of the GCMI. The steepest hurdle has not been money, he said, but "it was a matter of pulling the players together. With some partners we had done things together, and with some we had not. With some, we had natural competitive issues to work out. But everyone's come together, and is headed in the same direction."

"This new venture is an excellent example of Georgia's commitment to investing in innovative research at our universities, and of fostering collaborations that turn laboratory discoveries into applications that will meet global health needs," Cassidy of the GRA said. "The state is investing in ourselves. We're investing in the growth and the development of a promising industry here in Georgia. But perhaps more important, we're bringing innovation to the patient's bedside."

Added Peterson: "We're aiming actually for two kinds of results. The first is a better quality of life, through streamlining processes of bringing new medical technologies into use by bringing together key partners [and] providing a realistic context in which the design and development of new devices can be created, tested, and brought to market. And second, by providing new business opportunities that support the growth of Georgia's rapidly expanding medical device industry."

While the state may not have focused its life sciences efforts on medical devices until recently, it stands to benefit from the current industry trend toward convergence of life-sci technologies.

"We want to deliver drugs just where they are needed. What Georgia's always needed is a place in which we can develop prototypes and get things started. One institution can’t afford to pay for that," said Thomas Callaway, general partner with Georgia Venture Partners, an Atlanta venture capital firm specializing in seed- and early-stage investments of up to $1 million in Georgia life-sci companies.

Callaway spoke in an interview minutes after discussing the life sciences strengths and challenges of Georgia and the rest of the Southeast during a panel discussion on the final day of BIO 2009.

Callaway cited a recent example of such convergence in Georgia: Atlanta-based medical device maker Medtronic has developed glucose insulin pumps capable of not only reading the body's sugar level, but responding to that by pumping the amount of insulin required to control blood sugar.

Another challenge Georgia faces in drawing investment into its life-sci companies, he said, is the effort by some state officials to ban the creation of new human embryonic stem cell lines on moral grounds because of the destruction of embryos involved. A bill to that effect is pending in the state House of Representatives, whose science and technology committee will hold hearings this fall.

While declining to say if he'd sign the bill, Perdue expressed hope in a BRN interview earlier this month that the state and its life-sci industry can come to a consensus against destroying human embryos.

"It's an embarrassment. It doesn’t really impact us because [the bill] didn't pass. But the fact that it would be considered is of concern to me. Meanwhile, California invests $3 billion into [stem cell research]," Callaway said.

Developer, Regional Agency Commit to Life-Sci. Uses at Former Weymouth Naval Air Station

The developer of the former South Weymouth Naval Air Station and a regional development agency told the Weymouth (Mass.) News they remain committed to redeveloping the shuttered military outpost into a $1.5 billion mixed-use development that would include space for life sciences companies, despite mutual unease by each partner about the finances of the other.

LNR Property plans to build a 2 million-square-foot commercial complex designed to accommodate a pharmaceutical company or biotechnology firm as part of much broader redevelopment plans for the shuttered military outpost.

LNR is installing new infrastructure on the northern tier of the base to service the first 500 condominiums that will be built at the base. Plans call for 2,855 housing units in a new community called SouthField, through a mix of housing types that include rentals, apartments, condos, townhouses, single-family homes, and senior apartments. LNR's plan also includes a hotel, an 18-hole golf course, a hotel, a conference center, boutique shops, restaurants, hiking baths, walkways, and recreational fields.

The South Shore Tri-Town Development Corp., a joint venture of Weymouth and nearby Abington, Mass., and Rockland, Mass., told the News it wants to be sure that LNR has the financial means to sustain the project, after the developer was placed on credit watch by Standard & Poor's on March 26, citing the deterioration of the commercial real estate market and concerns about LNR's cash flow from its property holdings.

"We are trying to work with them in satisfying our bond and financial viability," corporation president Kevin Donovan told the newspaper.

LNR spokesman William Ryan told the newspaper LNR's issues are no different than scores of other developers scrambling to weather the economic slump: "The company has seen its share of ups and downs the past few months, but LNR's viability is not an issue here.

"Everybody is frustrated … The reality here is there has to be a viable public partner and a viable private business partner for the infrastructure needs. This is the reality of where the project finds itself," he added.

Ryan said that LNR has spent $75 million on new infrastructure at the base to accommodate the new structures being planned, as well as $11 million the developer has given to Tri-Town in recent years to help it with operation costs.

LNR owns 540 of the base's acres, while Tri-Town wants to buy the remaining 900 acres from the US Navy. But Tri-Town has missed a March 31 deadline to buy the land, and Donovan told the News Tri-Town is trying to negotiate the $43 million price sought by the Navy for the 900 acres.

The Navy has publicly questioned Tri-Town's commitment to the project, while Tri-Town and LNR have traded public uncertainty over whether the other partner is committed to the project. The Navy contends Tri-Town has failed to answer basic questions about the status of the project: "The silence from your side of this deal is deafening," Gregory Preston, a Navy base closure manager, wrote in an e-mail obtained by the Boston Globe.

At Mission Bay, UCSF Opens $135M Helen Diller Family Cancer Research Building

The University of California, San Francisco has opened on its Mission Bay campus its $135 million Helen Diller Family Cancer Research Building, a five-story, 163,865-square-foot facility that will more than double UCSF's laboratory space in buildings exclusively dedicated to cancer research.

According to UCSF, the research facility — designed by architect Rafael Viñoly — is the first UCSF building specifically focused on translational research for one particular disease. The facility will accommodate scientists studying brain tumors, urologic oncology, pediatric oncology, cancer population sciences, and computational biology. As a result, scientists of the UCSF Brain Tumor Research Center will be united in one facility for the first time ever.

UCSF said the facility is intended to strengthen and expand its commitment to translational research, and will serve as an integral part of the UCSF Helen Diller Family Comprehensive Cancer Center.

"Thanks to the generous support of Helen Diller, her family and many others, UCSF now has an expanded home for its integrated research and clinical cancer program, with the ability to contribute in a significant manner to advancing cancer care throughout the world," UCSF Chancellor J. Michael Bishop said in a statement.

Diller — who has donated $35 million toward the facility — is a Bay Area resident and longtime philanthropist whose giving has supported education, science, and arts groups. A decade ago, she created the Helen Diller Family Foundation of the Jewish Community Endowment Fund.

The Diller building is now home to about 250 cancer scientists and members of their teams working in 33 labs, and will eventually house about 400 professionals, according to UCSF.

Among design features of the new building are interlocking L-shaped wings — one containing labs, the other containing offices. Other highlights are a central atrium that creates a five-story open space, and terraced floor levels linked by bridges and cascading stairways.

Venter Institute, IGS, Broad Win NIAID Funding for Genomic Sequencing Centers

Three research institutions have been awarded grants from the National Institutes of Health's National Institute of Allergy and Infectious Diseases toward developing genome sequencing centers for infectious diseases nationwide.

The three include the J. Craig Venter Institute in Rockville, Md., which won a $43 million, five-year contract; the University of Maryland School of Medicine's Institute for Genome Sciences, located at the University of Maryland, Baltimore BioPark, which won $20 million; and the Broad Institute of MIT and Harvard, the value of whose contract was unavailable at deadline.

Contracts will cover the cost of the sequencing and analysis, and creation of a library of such information for sharing with researchers throughout the country. In return for proposing projects and providing samples, the outside researchers will gain access to the genomic information discovered at the centers.

CoreRx Eyes 55 New Jobs in Three-Year Expansion of Tampa, Fla., Headquarters

Pharmaceutical formulation development firm CoreRx will add 55 jobs over the next three years to its current workforce of 13, in a $5 million expansion of the pharmaceutical formulation developer's Tampa, Fla., headquarters.

In return for the additional jobs, whose average $58,445 annual salaries are projected at 150 percent of the state's average annual wage, CoreRx is eligible for Florida's Qualified Target Industry Tax Refund incentive.

At the behest of several of our clients, CoreRx is looking to the future, and expanding," CoreRx President and CEO Todd R. Daviau said in a statement. "We will be expanding not only our formulation laboratory, but we will be increasing the size and capabilities within our analytical, formulations and manufacturing departments."

As part of that broader expansion, CoreRx is in the process of purchasing a facility in Hillsborough County to replace its current leased site, Daviau told the Tampa Bay Business Journal.

Over the next several months CoreRx plans to go from its current 10,000 square-foot facility to a space of about 80,000 square feet. The new facility will be equipped with over 15,000 square feet of laboratory space, eight formulation development suites and 11 cGMP manufacturing suites, including cytotoxicity suites.

Life Technologies Expands its Leased Frederick, Md., Building

Life Technologies has signed a lease to occupy all of 7311 Governor's Way, a 56,438-square-foot industrial/flex building in Frederick, Md., owned by J&N Properties. In addition to leasing the building for 10 years, Life Technologies plans to expand it for pharmaceutical distribution, Chad Tyler of Tyler Donegan Real Estate told GlobeSt.com.

Tyler and Joseph Donegan represented J&N in lease talks, while CBRE's David Palank and Frank Graybeal represented Life Technologies.

Tyler told the real estate news web site Life Technologies will spend about $1.5 million to renovate the building, completed in 1993. The building's "asking" rental rate sought by brokers was $7.25 per square foot, triple net.

GE Healthcare Opens Digital Mammography Production Facility in North Greenbush, N.Y.

GE Healthcare recently opened a new digital mammography production facility at the Rensselaer Technology Park in North Greenbush, N.Y.

The 230,000-square-foot facility will add 150 manufacturing jobs with an annual payroll of $10 million. Investment in the facility totals over $165 million, including a capital grant of $10 million from New York state, according to the company.

“This wonderful example of how a long-term commitment to technology can spur the growth of our manufacturing base and create new high-tech jobs,” said Mark Little, senior vice president and director, GE Global Research, during a June 5 grand opening ceremony. “We spent 15 years developing GE’s revolutionary digital X-ray technology at our Global Research Center in Niskayuna. Today, we celebrate the opening of a new production facility that will manufacture and transfer this innovative technology to all corners of the world.”

While other GE businesses have a long history in New York, this will be the first expansion of high-tech medical equipment manufacturing by GE Healthcare into New York state, the company noted.

“This dedicated mammography manufacturing facility is a great reflection of the company’s commitment to improving access to high-quality health care products worldwide,” said Mike Genau, general manager, diagnostic X-ray, GE Healthcare. “The market continues to be in an important transition period from analog to digital technologies and GE mammography offers some of the highest productivity and workflow efficiency in the industry. Despite the economic slowdown, we expect the global market to grow by 5% over the next few years. This new manufacturing facility will be a great asset for the company to meet the needs of our customers and patients all around the world.”

The building has achieved USGBC LEED Gold Certification, making it one of two semiconductor manufacturing facilities in the United States to achieve this status, according to GE Healthcare.

Headquartered in Chalfont St. Giles, United Kingdom, GE Healthcare is a $17 billion unit of General Electric Co., employing more than 46,000 people worldwide.

Velesco Adds Clinical Trial Manufacturing to Offering

US contractor Velesco Pharmaceutical Services has leased a new clinical trial materials manufacturing facility in Kalamazoo, Michigan, extending its range of preclinical and early trial development services.

The 10,000 sq. ft. plant will produce non-sterile supplies for early phase trials and has the capacity to handle pharmaceutical powders, ointments and creams, as well as oral and topical liquids.

The unit will also provide trial-specific services including over-encapsulation, used to ensure that studies are conducted in controlled conditions, and a range of trial pack manufacturing options.

Velesco COO Gerry Cox told Outsourcing-pharma.com that the idea behind the new facility is to create “a ‘one-stop shop’ for our clients in need of the formulation, analytical and clinical supplies support required to move from preclinical to the clinic.”

He added that: “Velesco's goal is to provide the formulation and analytical services along with the clinical supplies needed by our clients to achieve the "proof of concept in humans" milestone.”

Cox was also confident about the level of demand for trial supply manufacture despite the higher project cancellation rates reported by some contract research organizations (CRO) in the last few months.

“The global economic downturn has certainly had an impact on the industry but Velesco's business continues to grow. We are a young company and we are focused on controlling our cost structure as we move through the current downturn.”

This assertion fits with comments made by CROs like Covance and Charles River Laboratories which also focus on the preclinical and early trial market. Both have recently predicted that the decline in demand for such services is beginning to recover.

Velesco has also moved its analytical and formulation laboratory from Ann Arbor to a larger facility in Plymouth, Michigan that was previously owned by global drug giant Pfizer.

The laboratory expansion and the new trial manufacturing facility are sure to be welcomed by the other members of the Michigan CMC Alliance, which Velesco joined in April.

The group allows Velesco and other contract services firms like Ash Stevens, BioSTAT Consultants, PharmaMed and ProReg to pool resources and provide a broader range of services.

Another factor likely to have influenced Velesco’s expansion is its receipt of a high tech mega tax credit from the Michigan Economic Growth authority which, the firm said, will significantly enhance its operational capabilities.

The Hudson-Alpha Institute for Biotechnology’s Opens in Alabama

In Alabama, the Hudson-Alpha Institute for Biotechnology’s 270,000-square-foot facility at Huntsville’s Cummings Research Park held its formal grand opening in April 2008, but the ribbon-cutting of its Associates Wing, filled to capacity with 12 biotech tenants, had already taken place in November 2007. The institute’s research focuses on “personalized medicine,” which uses DNA mapping technologies; it recently established the new Genomic Technology Center for Public Health and Food Safety.

BioLife Completes Construction and Validation of GMP Manufacturing Facility

BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading biopreservation tools provider, announced that it has completed the construction and validation of its internal GMP manufacturing facility and has released the first production lot of its biopreservation media products made in Bothell, WA. for commercial sales.

In the third quarter of 2008, the Company announced that it was transitioning from using a contract manufacturer to internal production in order to reduce production costs and enable custom packaging and formulation offerings to the growing market for biopreservation media products.

BioLife's Quality System and nearly 6,000-square-foot GMP production facility incorporates a uni-directional workflow design that was finalized with the input of several clean room consultants and members of BioLife's Quality, Scientific and Regulatory Advisory Board. The facility consists of ISO14644 classified airlocks and rooms for product formulation, filling, final inspection and cold storage, as well as other mixed and dedicated use space including research and development and quality control laboratories and order fulfillment space. All critical systems are supported by auto-switched generator power.

Mike Rice, BioLife's chairman and CEO, noted, "We're very pleased to have met our cost, schedule, and quality goals for this construction project. We now have the capacity to produce up to 12,000 liters of HypoThermosol and CryoStor biopreservation media annually, and have the ability to increase this significantly by investing in additional automation equipment. Over the coming quarters, we expect to realize volume driven cost reductions and will leverage our internal production capabilities to offer custom packaging and product variants to meet customer demand for our best-in-class biopreservation media products."

Canary Funds Early Cancer Center at Stanford

Stanford University will use a $15 million commitment from the Canary Foundation, along with $5 million of its own funds, to start a cancer research center focused on using proteomics and imaging techniques to find ways to identify cancer earlier.

The foundation said that the Canary Center at Stanford for Cancer Early Detection will conduct proteomics research for blood and body fluid biomarkers that could be developed into in vitro diagnostic tests, as well as molecular imaging studies that could help verify the presence and location of tumors.

The center is located in a renovated School of Medicine building in Palo Alto, and it will work with the National Cancer Institute through the Stanford Cancer Center in order to translate its early detection discoveries into clinical practice, the foundation said. The center will seek to hire new faculty for in vivo and ex vivo diagnostics research, and it will be led by Sanjiv Gambhir, who is director of the Molecular Imaging Program at Stanford.

The foundation said its goal is to fund early detection technologies that will give doctors "a much better chance of treating and even curing cancer."

Don Listwin, who is founder and chairman of Canary Foundation, said in a statement that the Stanford center is a realization of its goal to start "the first integrated facility that can attract and develop the best minds in the world to tackle the problem of cancer early detection."

CoreRx Eyes 55 New Jobs in Three-Year Expansion of Tampa, FL, Headquarters

As part of that broader expansion, CoreRx is in the process of purchasing a facility in Hillsborough County to replace its current leased site, Daviau told the Tampa Bay Business Journal.

CoreRx to Buy New Manufacturing Site

US contract services group CoreRx has unveiled plans to purchase a new manufacturing site in Hillsborough County, Florida, according to a report in the Tampa Bay Business Journal.

The new 80,000 sq. ft. facility will provide clinical trial manufacturing services for the pharmaceutical industry and create as many as 55 new high tech manufacturing jobs as it is rolled out over the next three years.

The plant, further details of which have not yet been released, is approximately eight times the size of CoreRx’ existing manufacturing unit, and will include capacity for the firm’s formulation, analysis and research offering.

CEO told the paper that, as a result of the jobs it will create: “the firm has applied for Florida’s Qualified Target Industry Tax Refund (QTI) program,” explaining that the roles will have average salaries of at least $58,445, equivalent to 150 per cent of the state average.

While the preclinical research and clinical research markets have been hurt by the cost cutting and R&D cutbacks that dominate the drug industry at the moment, in general, demand for contract manufacture has continued to grow.

What is unclear is how the slowdown in drug development will impact on the contract production of drug batches for clinical trials in the medium to long term as fewer drug candidates move into human trials.

This lack of visibility is perhaps why CoreRx is hedging its bets with the new facility and providing a range of contract development and manufacturing services.

Temple University School of Medicine's New $160 Million Building Is Complete

After nearly three years of construction, Temple University School of Medicine's new $160 million building is complete. The 11-story, 480,000-square-foot building, designed by Ballinger (Philadelphia, Pennsylvania), will offer both medical education and research. The school tapped the Gilbane Building Company (Providence, Rhode Island) to handle construction of the project

Perlegen Sciences Receives Certification for a New Clinical Lab in Mountain View, CA

Genetic testing company Perlegen Sciences has received certification for a new clinical lab in Mountain View, Calif.

The company said it received Clinical Laboratory Improvement Amendments certification from the California Department of Public Health's Laboratory Field Services and has opened the facility.

Perlegen CEO Bryan Walser said in a statement that the opening of the lab is "a significant advance in our efforts to commercialize Perlegen's key genetic tests," which the company will begin with the launch this fall of the MammaPlus genetic test for breast cancer risk.

Recession Saps Progress for Genesis Biotechnology Campus & Research Sites in New Jersey

The governor's top official on economic growth met recently with the developer of a biotechnology research hub at Klockner and Kuser roads, but the company says the stalled project remains on hold during the economic downturn.

Representatives of the group behind the 410,000 square-foot Genesis Biotechnology Campus met with Jerry Zaro, chief of the Governor's Office of Economic Growth, and Hamilton officials on May 13.

The meeting was productive but largely informational, according to several attendees who said the developer's plans remain stagnant and the state has not yet offered any concrete incentives that might spur action.

"It's status quo, nothing has changed," Michael Gale, vice president of operations and corporate development for Hamilton-based Sherute LLC, a sister company of the Genesis group, said when asked about the project. "Economic conditions certainly aren't helping with anything."

The biotech campus, long coveted by the township as a quality commercial site that would bring high-tech jobs and prestige to the area, was put on hold indefinitely about a year ago.

Genesis had filed plans for the project in early 2007, but was bogged down for more than a year in negotiations with Hamilton over fees for road improvements associated with the construction.

As the talks dragged, construction costs on the multimillion dollar project rose by as much as 20 percent, Gale has said.

Officials with Genesis have spoken at times about moving the project out of Hamilton and even out of the state, prompting Mayor John Bencivengo to ask Gov. Jon Corzine for help.

During the May meeting Zaro, appointed by Corzine in October 2008, received an update on Genesis and other projects in the area, according to Jennifer Monaghan, communications director for the Office of Economic Growth.

"As a result of the meeting, we are exploring ways that we can be of assistance to them," Monaghan said. She noted that the state Economic Development Authority has "a slew of programs and incentives" that could be available.

Asked about the incentives, Gale said "we haven't really gotten that far. With the economy the way it is, we're content to sit still. We'll re-evaluate if the outlook looks more promising."

The May meeting "wasn't necessarily (about) Genesis. It was more, from our perspective ... (about) what help is available" for the company in general, he said.

"At the state and township level, everybody seems willing to help us any way that they can," Gale explained. "(Town and state officials) certainly have expressed very strongly that they would like us to stay here, not only in Hamilton but also in New Jersey."

The plan for the Genesis campus, still exhibited on a sleek website, shows a facility with several buildings for laboratory space, offices, a fitness center and auditorium.

The campus is designed to attract high-tech start-ups in biotechnology research to one place, creating a hub for scientists who might also exchange ideas.

Prospective tenants include "Humigen, the Institute for Genetic Immunology," a company that studies the relationship between human genes and the body's response to diseases, according to the website.

"Its a great project (with) good jobs," said Mike Angarone, Hamilton's director of technology and economic development, who was present at the May meeting.

Angarone said such a project would also boost the town's "credibility" and perhaps attract other high-tech firms.

Hamilton will "do everything we can within the bounds of the law to give them some kind of incentive to stay here," he said. "I really get the impression that they want to stay in Hamilton. They own a lot of land here, (they) have a lot of investment here, I think it's a good fit."

Behind the family of companies that spawned Genesis are two well-known local names: Dr. Eli Mordechai, a scientist with local ties, and Jerry Moradi of Moradi Enterprises.

That family of firms already has a strong presence in Hamilton, with sister companies Medical Diagnostic Laboratories LLC and Worldwide Medical Products Inc. also located here.

Althea Completed Initial Phase of Its Manufacturing Facility Expansion

Althea Technologies intent is to accelerate gene-based drug development by providing a comprehensive portfolio of services to support biopharmaceutical companies in all phases of drug development. They manufacture injectables and do all clinical and commercial packaging as well.

**As of January 2006, Althea has completed the initial phase of its manufacturing facility expansion. The project includes expansion of the existing cGMP manufacturing facility including an overall increase of Althea's fermentation and purification facilities by 30 %, a doubling of early manufacturing suites, allowing for a significant gain in project scheduling and flexibility. The thrust of Althea's expansion will be to provide continued development and manufacture of novel biopharmaceuticals coupled with new genomic information.

**As of June 2009, Althea Technologies, Inc., a leading provider of services for biopharmaceutical development and manufacturing, hosted a ribbon cutting ceremony today to mark the opening of its newly constructed state-of-the-art, commercial-scale cGMP manufacturing facility in San Diego, CA. Althea’s employees and board of directors, together with City of San Diego Mayor Jerry Sanders, Matt MacKowski of Telegraph Hill Partners, Steve Cusato of City National Bank, and key invited guests, celebrated the commissioning of its new facility at the Althea campus in Sorrento Valley.

Co-Founders Magda Marquet and François Ferré remarked, “This is the culmination of a dream we envisioned when we founded Althea Technologies, which was made possible by the investment and support of our Althea team and our key partners at Telegraph Hill Partners and City National Bank.”

The decision to create expanded capacity was brought about by the need in the region to keep pace with the growing needs of the industry to outsource biological and injectable product manufacturing. A significant segment of the biotechnology industry consists of companies focused on research & development that do not have the expertise or capital to invest in a manufacturing facility. Manufacturers, such as Althea, allow biotech companies to keep focus on their core competence in R&mp;D.

“The decision to expand our capabilities and design a new facility was made with careful consideration of our clients’ needs,” commented Dr. Shabbir Anik, Althea President and CEO. “The new facility was designed to provide flexible capacity and expand our services from early clinical development through Phase III and commercial supply. This expansion gives clients a more efficient and faster option to bring their products to the market,” said Dr. Anik.

“We are very excited to launch our 30,000 square foot commercial-scale cGMP manufacturing facility because it allows Althea Technologies to take an integrated approach in the manufacturing of exciting new biotechnology derived therapies. The completion of this building marks a significant milestone in our ultimate goal of accelerating the development and delivery of novel therapies to the people who need them most,” stated Dr. Magda Marquet, Co-Chairman and Founder.

Among the unique features of the new cGMP facility are its compliance with both U.S. and European manufacturing regulations and its state-of-the-art building management system that ensures a sterile manufacturing environment.

Althea Technologies successfully partnered with City National Bank and Telegraph Hill Partners to secure the necessary funding for the project. “The ability to undertake the construction of a commercial facility costing over $15 million to increase our production capacity and build on our service offerings is remarkable for a company the size of Althea,” said Dr. Anik. As a company that prides itself on doing business with San Diego, all of the construction services were provided by San Diego-based businesses.

“The commercial expansion will enable Althea to contribute to the economic vitality of the region through the addition of personnel and the ability to help ensure the continued success of more biotech companies,” said Dr. François Ferré, Co-Chairman and Founder of Althea Technologies.

About Althea Technologies, Inc.

Althea Technologies, a leading San Diego-based biologics and pharmaceutical services firm, provides critical manufacturing services that support researchers worldwide in their advancement of novel therapies and efforts to apply new genomic information. Althea’s services include cGMP contract manufacturing of recombinant proteins, DNA-based therapeutics and vaccines, and aseptic filling. For more information, visit www.altheatech.com.

Construction Is Under way on a State-of-the-Art Cancer Research Centre in New Orleans

Construction is under way on a state-of-the-art cancer research centre, one of the first new major construction projects to begin in the city since Hurricane Katrina.

Designed by international architects RMJM, the 175,000-square-foot facility will include flexible research space, office space and support laboratories for 72 principal research teams.

The 10-storey, bricks and mortar centre has been on the drawing board for most of the past decade. The design was completed shortly after Katrina struck.

“It has been a long time coming, but the project is definitely on course now,” said Steven Moye, president and CEO of the Louisiana Cancer Research Consortium, which will operate the facility. LCRC is a collaboration of the health sciences programs of three state universities.

“It is the first of many state-of-the-art medical facilities planned for the city and it will pioneer breakthrough advances in detection, treatment and prevention of cancer while fostering economic development in downtown.”

The research centre is located in what is known as the Greater New Orleans Biosciences Development District, that will also include the BioInnovation Center.

Three of the floors of the building being constructed by Brice Construction will be dedicated to cancer research laboratories for LCRC’s immunology, molecular signaling and molecular genetics research programs.

One floor will house a vivarium and LCRC’s executive offices. Four floors will be dedicated to parking. A large theatre-style meeting facility will be located on the first floor. With seating for 250, it can be used for scientific meetings as well as community events.

The remaining floors will be flexible “white box” spaces for future growth as laboratories, offices or clinical services. Construction of the $65 million building is expected to be complete in 2012.

“The design combines two strong forms: a raised sculptural volume designed as a symbol of hope,” said R. Stephen McDaniel, RMJM’s leader in designing healthcare and research facilities. “The other is a two-storey glass element parallel to Tulane Avenue, which includes the lobby and conference center.”

RMJM is an international leader in designing cancer research facilities. In addition to the LCRC, RMJM has designed the Champalimaud Cancer Center in Lisbon, Portugal, the Mitchell Cancer Institute at the University of South Alabama and the Cancer Institute of New Jersey in New Brunswick, N.J.

Other RMJM health and research projects include hospitals in New York City, Philadelphia, Singapore and Princeton as well as medical schools and biotechnology facilities in various locales.

For LCRC, the firm partnered with Lyons and Hudson Architects, with mechanical engineering by Vanderwell in collaboration with New Orleans-based Wink Engineering

ATMI, Inc. Plans Improvements to Manufacturing Facility in Bloomington, MN

ATMI, Inc. announced plans to double its global production capacity of ultraclean, disposable bioprocess vessels for life sciences applications through upgrades and modifications to its North American manufacturing facility in Bloomington, Minn. The site, which supplies products for the integrated circuit (IC) and flat panel display (FPD) markets, adds a Grade B cleanroom for fabricating complex three-dimensional storage, mixing and bioreactor vessels for life sciences customers. In addition to maintaining its current IC and FPD operations, the plant upgrade will entail creation of an on-site quality testing laboratory.

"ATMI has been developing and manufacturing one-time use mixing, reactor and storage solutions for the life sciences market for the past few years," said Doug Neugold, ATMI Chief Executive Officer. "As a result of successfully placing multiple qualification units with key North American customers -- and their increasing application of this technology in development and manufacturing -- we're accelerating our investments for production here."

The company will continue its present manufacturing of bioprocess vessels at the ATMI LifeSciences plant in Belgium. By using copy-exact methods from that facility, the company can swiftly replicate a CGMP (Current Good Manufacturing Practices) operation in Minnesota and bring it online -- effectively doubling its global bioprocess vessel capacity. The time-frame targeted for qualifying North American production is 4Q 2009; commercial products are expected to ship in 2010.

"Our customers have asked us to provide them with greater disposable bioprocess vessel capacity, along with global contingency and continuity of supply for their critical ultraclean bioprocess storage, mixing and bioreactor vessels," said Mario Philips, General Manager of ATMI LifeSciences. "Increasing our manufacturing footprint addresses the rapidly increasing demands of the biopharmaceutical marketplace."

Beyond its new Grade B cleanroom, the upgraded North American facility will house a bio-burden test laboratory to analyze and manage sterility levels in the manufacturing environment. With these additions, ATMI continues to capitalize on its proficiency in semiconductor, clean room and ultrapure manufacturing and to leverage that expertise in the life sciences market.

About ATMI LifeSciences

ATMI LifeSciences is a leader in single-use mixing, storage, and bioreactor technology, fluoropolymer-based products, and custom-engineered, flexible packaging solutions. The business's fundamental knowledge of polymers, specially selected resins, and its clean room manufacturing experience coalesce to help drive optimum performance in critical disposable process operations.

For more information, please visit http://www.atmi.com

New R&D Facility for Tek Pak

Tek Pak, Inc. of Batavia, IL has announced the grand opening of its new Research and Development Center in St. Charles, IL. The new building was purchased in 2008 as a result of Tek Pak's expanding product development program, which had outgrown its facilities in the main manufacturing plant in Batavia. Renovations to the facility located in the Legacy Business Center adjacent to the East Side Sports Complex east of Kirk Road in St. Charles were recently completed, and the facility is now fully operational. Nine full-time employees and 2 college interns currently work at the location.

"A specially-equipped facility was required to accelerate the development of Tek Pak's proprietary processes to manufacture custom thermoformed products for demanding applications in the electronics, medical and industrial markets," said Scott Carter, VP-R&D. The entire facility is environmentally controlled, and it contains a HEPA-filtered laboratory for operations that require limited amounts of air-borne particles. In addition, installation of an ISO-classified clean room is scheduled for the 3rd quarter of 2009 for medical device packaging operations.

A total of 5 thermoforming lines are currently operating in the Center which process films made from engineering resins that include Ultem(TM), Valox(TM), Lexan(TM), and PEEK(TM). Other proprietary processes include a laser cutting system for intricate drilling and trimming operations and a conveyorized system to thoroughly clean and dry thermoformed parts prior to packaging.

"Our new state-of-the-art R&D Center gives Tek Pak the ability to fully satisfy our customers' product development needs now and well into the future. The facility provides Tek Pak with a strategic tool to penetrate new markets, diversify our customer base and to grow sales, which is crucial to our mission of continuing to provide high-quality jobs in the US," said Tek Pak President, Tony Beyer.

About Tek Pak, Inc.

Tek Pak was founded in 1992 to provide custom carrier tape for the cell phone market. Originally occupying 6,000 sq. ft. at its Batavia, IL location, the Company now occupies 27,000 ft2 in their Batavia location, nearly 11,000 sq. ft. in St. Charles, IL, 2,500 sq. ft. in San Jose, CA, and a sales/engineering office in Orebro, Sweden. While the original product, carrier tape for the electronics industry, is still a significant portion of Tek Pak's business, the Company now provides complete thermoforming solutions including part design, tooling, tool repair, prototyping, machine design and fabrication, short-run thermoform production, and precision thermoforming of engineering films. Tek Pak serves the electronics, medical, industrial, food, and retail markets.

SAFC Partners with Cherokee to Improve Pharma Raw Material Supply

SAFC is seeking to improve its large-scale supply of pharma raw materials through a partnership with Cherokee Pharmaceuticals, which will use its expertise to ensure the products meet cGMP standards.

The globalization of the raw material supply chain has increased the risks involved, leading to high profile contaminations such as diethyl glycol and prompting increased vigilance from suppliers and buyers.

Cherokee has analytical laboratories and large-scale current good manufacturing practice (cGMP) compliant manufacturing, which SAFC believes can help protect the supply chain and complement its expertise in sourcing reagents and excipients.

Gilles Cottier, president of SAFC, explained: "This agreement is a win-win situation, not only for SAFC and Cherokee Pharmaceuticals, but also for our respective customers.

“In marrying SAFC's sourcing capabilities, which bring significant cost and quality benefits to the table, with Cherokee Pharmaceuticals expertise in analytical testing and cGMP manufacture and storage, we are providing top level, high-quality resourcing that will support our US customers throughout their respective supply chains, enabling them to both streamline and improve their risk mitigation strategies."

Under the terms of the partnership SAFC will source the raw materials using its network of over 10,000 active suppliers, with Cherokee taking responsibility for analytical testing, storage, packaging and distribution services.

Cherokee’s site

Cherokee’s parent company PRWT Services acquired the Riverside, Philadelphia, US facility that will be used in the partnership from Merck & Co in 2008.

The partnership will use the site’s fully cGMP validated facility, which can house cooled, frozen and hazardous substances. In addition the site’s location and dedicated rail link make it suitable as a distribution hub for pharma companies based on the east coast.

Integrated Genomics to Re-locate to Wisconsin, Gets $250K from State

Wisconsin will provide $250,000 to Integrated Genomics through a combination of a loan and a grant, and the company plans to relocate its laboratory and commercial operations from Chicago to Madison, the state's governor's office said.

The state will give the microbial genomics and gene expression services and technologies company a loan of $200,000 and a grant of $50,000 from the Technology Venture Fund. It said that Integrated Genomics' move could create up to 18 new jobs.

The company plans to use the funding to pay for relocating the laboratory to Madison and to buy equipment.

Wisconsin Governor Jim Doyle said in a statement that Integrated Genomics "is exactly the type of company our state should be investing in – companies that are developing innovative solutions in the biotechnology industry."

HHS Awards MedImmune Contract to Manufacture Live Attenuated Nasal Spray Vaccine for Novel Influenza A (H1N1)

MedImmune has announced that the U.S. Department of Health and Human Services (HHS) has awarded the company a contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations identified by HHS in the National Strategy for Pandemic Influenza. An initial order of $90 million of vaccine has been placed, with the potential for additional orders. This project has been funded in whole or in part with the Federal funds from HHS/ASPR/BARDA, under Contract No. HHSO100200900002I. MedImmune scientists have identified several promising vaccine candidates against the Novel Influenza A (H1N1) strain, and are currently evaluating their growth properties and antigenicity (i.e., their ability to stimulate antibodies) for mass production as part of the vaccine manufacturing process. "MedImmune is pleased to be able to contribute our scientific expertise in influenza vaccine development and manufacturing to help combat this unpredictable public health threat," said Ben Machielse, Drs., executive vice president of operations, MedImmune. "We are confident that our vaccine technology has several attributes that may be useful in protecting people with limited exposure to influenza against the Novel Influenza A (H1N1) strain." MedImmune's live attenuated influenza vaccine (LAIV) technology may be particularly well-suited for vaccinating against emerging influenza strains. LAIV is different from the injectable influenza vaccine ("flu shot") in that it is a gentle mist sprayed into the nose, where the influenza virus usually enters the body. It contains live vaccine virus strains that are weakened so as not to cause the flu, but prompt the body to mount an immune response after the first dose. Because it is live and stimulates a broad range of immune responses, LAIV may offer some cross-protection against circulating flu strains that are "drifted" - meaning they are very closely-related but not perfectly matched to the flu strains in the vaccine.

As a needle-free nasal spray, LAIV is well suited to facilitate mass vaccination, and has been widely used for school-based vaccinations and to help protect active-duty military personnel.

IDT Biologika Establishes New Corporation in the United States

IDT Biologika has opened new offices outside Washington, DC in Herndon, VA to better serve pharmaceutical and biopharmaceutical customers in the United States. The move comes in response to expanding business by IDT Biologika with multinational firms and increased demand for the company’s fully-integrated services in the U.S. market. IDT Biologika operates one of Europe’s premiere integrated pharmaceutical and biological development and manufacturing facilities with the expertise and quality controls to supply world markets. IDT Biologika’s expanded footprint in the Unites States market coincides with the opening of new filling and packaging facilities in Germany this past January.

According to Dr. Ralf Pfirmann, CEO of IDT Biologika, the establishment of operations in the United States will allow the company to support its customers´ operations in the important U.S. drug market and to develop closer working relationships with firms in the region. “IDT Biologika has had an excellent reputation in Europe as one of the premiere outsourcing partners for pharmaceutical companies for over two decades – particularly in the area of biologics. During this time, we have continually improved our facilities through investment and have developed the personnel and business processes commensurate with a global supplier of these services to the industry,” he said. “The opening of a United States location is a logical next step in our growth to become a global supplier of sterile liquid dosage forms,” he added. In addition to sterile liquid dosage forms, IDT Biologika employs innovative approaches for vaccines using the latest technologies in sterile production and operational expertise gained from many years of contract manufacturing experience.

IDT Biologika has invested more than € 200 million in the last 15 years building a highly modern and efficient biopharmaceutical site at Dessau-Roßlau, Germany. Today, IDT Biologika runs a biopharmaceutical site that offers customers access to highly integrated development and manufacturing, including one of the most comprehensive quality control and testing programs in the industry. “IDT Biologika has the capability for a complete range of testing methods for biopharmaceuticals on our Dessau-Roßlau site. These capabilities range from standard physiochemical methods and microbiology, to virology, molecular biology and animal models,” said Pfirmann. “We have these capabilities because of our experience in vaccine and biologics development,” he added. All IDT Biologika facilities have been inspected by international regulatory agencies such as EMEA and FDA. Just recently, in March this year, IDT Biologika was successfully inspected by the Canadian FDA and has successfully worked with Asian regulatory authorities.

According to Pfirmann, the United States market is ready for IDT Biologika’s combination of quality, integrated facilities and flexible, responsive business models. “Because of our decades of experience working on biologic treatments for our own products as well as for pharmaceutical industry third parties, we understand the business needs of our customers for fast response and decision making, state-of-the-art technology and integrated solutions – all set on the backdrop of a relentless commitment to quality,” he said. “We’re looking forward to being of greater service to our global customers and to introducing IDT Biologika to a broader spectrum of US companies,” he added. Running the new office will be Mr. Peter Linzmeyer, Executive Vice President of IDT Biologika Corporation – a wholly-owned subsidiary of IDT Biologika GmbH

Converting-Biophile Laboratories

Tom Hilbert Sr. is requesting expansion at his medical device manufacturing business located at 441 Cedar St., at the T-intersection of West 11th Street, Fond du Lac, WI.

Converting Biophile Laboratories currently operates two shifts. It is an FDA-certified registered cleanroom facility that makes medical devices that are used all over the world, according to Hilbert.

Exceptions to city zoning code are requested regarding land use, rear yard setback and number of parking spaces.

Hilbert is proposing three construction phases: Phase 1, 1,663-square-foot addition; Phase 2, 2,816-square-foot addition; and Phase 3, 3,911-square-foot addition.

Total building area, upon completion of all expansion phases, will be 24,360 square feet.

Hilbert said expansion would add a number of jobs. He currently has between 45 and 75 employees, depending on workload.

Brock University, Niagara College gets $40M for Applied Health Institute

It’s something Niagara College President Dan Patterson would refer to as a win-win.

But there were more than two victors when upper-tier governments announced $40 million in cash, split between the federal and provincial levels, for the college’s yet-to-be-built Applied

Health Institute.

Also winning was Brock University, which received $38 million in federal funding for its $109-million Niagara Health and Bioscience Research Complex, to go with $33.5 million in previously announced provincial funding.

But, perhaps the biggest winners are the employers of present, and tomorrow, who are assured that with the investments in post-secondary education, Niagara and Ontario will have one of the most-skilled and knowledgeable workforces in the world, said Ontario Minister of Training, Colleges and Universities

John Milloy, “We have to make sure we have the most highly skilled, highly educated workforce on earth if we want to continue to compete and prosper,” he said.

The announcement of federal cash was made Monday at Brock by Milloy as well as federal Industry Minister Tony Clement. Together, the two announced more than $1.1 billion for 28 projects at post-secondary institutions across the province.

The money is from the federal government’s $2-billion Knowledge Infrastructure Program announced in January and the province’s $780-million for post-secondary institution infrastructure announced in the 2009 budget. The programs are part of the governments’ stimulus measures designed to provide a short-term boost to the economy by creating construction and other spin-off jobs and building important infrastructure for the future.

The projects were selected by evaluating their potential boost to the local economy, along with their ability to meet the college criteria of strengthening the delivery of advanced knowledge and skills training or university criteria of improving the quality of research and development. Clement said the economic downturn represents an historic moment because of its global nature.

“There’s no question we are living through a period we will all remember, for better or worse, for years to come,” he said.

He said the research being done at institutions like Brock is necessary, as it is innovation which will drive the economy in the future. Canada has always been known as a source of great natural resources, but people are the county’s greatest asset, he said.

“It is our people who will drive our future economy,” he said.

Wearing a wide smile, Patterson said the institute will boost the capacity to train health-care workers at the college, noting 70 per cent of health care professionals are college-educated. The institute will not only increase learning space, it will also provide clinical services for vulnerable populations in Niagara.

“This project is a major leap forward,” he said.

Shovel-ready, the institute will begin construction this August for targeted completion in February 2011.

Brock’s health and bioscience research complex will produce world-class research in a number of areas, including cancer, biotechnology and green chemistry, and will also house a business incubator to help bring ideas from the laboratory to the marketplace, leading to new businesses starting up by graduates here in Niagara.

R&D Cluster at UQ Transitions Queensland, Australia, 'From Bricks to Brains'

Australian officials joined life sciences leaders this week in opening a A$30 million (about $24 million) R&D cluster at the University of Queensland’s Australian Institute for Bioengineering and Nanotechnology. The cluster consists of three facilities — the Biologics Facility, the Metabolomics Facility, and the Australian National Fabrication Facility — that employ a total 30 staffers.

The three "are a major step forward for research and development in Queensland … This investment exemplifies the Queensland economy's transition from 'bricks to brains',” said Australia's Treasurer and Minister for Employment and Economic Development Andrew Fraser, according to the Queensland Business Review of Spring Hill.

The Queensland government committed $14 million to the initiative, with another $11.5 million coming from the Australian federal government's national collaborative infrastructure strategy, and $4.75 million from UQ.

AIBN Director Peter Gray told the Business Review the facilities will build more bridges between the public and private research sectors, expand national capabilities, develop new industries, and promote Australian innovation, adding: "This cluster of national research and development infrastructure is one of the newest and largest collections of its kind in Australia."

Queensland research projects are being given a much-needed boost with the opening of a $30 million R&D cluster at the University of Queensland’s (UQ) Australian Institute for Bioengineering and Nanotechnology (AIBN).

Treasurer and Minister for Employment and Economic Development Andrew Fraser has officially opened three state-of-the-art facilities.

"This investment exemplifies the Queensland economy's transition from 'bricks to brains'," he says. "The three new facilities opened today, the Biologics Facility, the Metabolomics Facility and the Australian National Fabrication Facility, are a major step forward for research and development in Queensland.” Fraser says the new centers constitute one of the largest and newest research and development clusters in Australia.

"Each of the facilities is part of a wider Australian network which enables our researchers to collaborate across state and institutions and gives them access to technologies and know-how anywhere in Australia," he says.

The Queensland Government committed $14 million to the initiative, with another $11.5 million provided through the Federal Government's national collaborative infrastructure strategy and $4.75 million by UQ.

Funding from the State Government is part of an ongoing commitment to supporting research and development capacity, according to Fraser.

"These facilities are operated by 30 staff and provide valuable assistance to Queensland's science community, increasing its research capability as well as its rate of drug discovery,” he says.

"These capabilities will help the State sustain long-term economic growth and employment as well as provide new discoveries that offer significant health and environmental benefits to the community.”

AIBN Director Peter Gray says the facilities will build more bridges between the public and private research sectors, expand national capabilities, develop new industries and promote Australian innovation.

"This cluster of national research and development infrastructure is one of the newest and largest collections of its kind in Australia," Gray says.

"It also coalesces with the extensive facilities available through the NCRIS-supported Australian Microscopy and Microanalysis Facility, which also has equipment located in AIBN,” he says.

The university’s newest laboratories are available to all Australian research organizations, including industry groups.

"The infrastructure enables globally competitive research in the areas of biologics, metabolomics and nanofabrication by providing Australian researchers with access to internationally acknowledged expertise and equipment,” Gray says.

Board Rejects Denser and Scaled-Down Alternatives for Gaithersburg ‘Science City'

The Montgomery County Planning Board has turned back several efforts to reconfigure the development plan for the Belward Farm in Gaithersburg, Md. — the largest undeveloped parcel in and around the Shady Grove Life Sciences Center — and is instead forging ahead with plans for a 'Science City' of up to 4.5 million square feet of buildings up to 143 feet high, according to Maryland Community Newspapers.

The 107-acre Belward Farm, off Darnestown and Muddy Branch roads, is a lynchpin in the plan to transform the 900-acre Shady Grove district into a live-work research hub with 20 million square feet of laboratory, office, and commercial space, projected to support 60,000 jobs over the next 30 and 40 years.

Johns Hopkins University, which owns Belward, sought up to 6.5 million square feet of development on Belward to create a research campus with enough critical mass to draw federal health and scientific research agencies.

David McDonough, senior director of development oversight in Hopkins's real estate division, told the planning board that the extra transit trips wrought by the additional development would make federal transit officials more likely to approve funding for the Corridor Cities Transitway, a proposed mass transit line that would form the backbone of the city's Gaithersburg West section.

And since federal agencies plan in broad, long-range time horizons, small projects are less likely to win funding from Washington, he added, according to the newspaper group: "It makes us more competitive. Size matters … If you want to have their interest, then you need to have a plan that entices them."

However, Planning Commissioner Jean Cryor disagreed with McDonough, saying the volume of potential riders will sway Washington less than the political clout of Hopkins and other advocates of funding for CCT: "If [we] think it's just going to be on numbers, we're just kidding ourselves," according to MCN.

Also rejected was an alternative plan by the group Reasonable Development that called for no more than 2 million square feet of construction. They also want the CCT to get to Muddy Branch Road by heading north up Great Seneca Highway, not across Belward. However, the commissioners refused to consider giving Hopkins a transfer of development rights so it could instead boost development at its existing Montgomery County campus, and picked apart the group's traffic projections.

"It makes little sense to have several transit stops in an area that isn't going to have the density to make the transit system cost-effective. Certainly, we won't get any federal aid for that," Planning Board Chairman Royce Hanson said, according to MCN.

County planners will incorporate the bio campus concept into their Gaithersburg West master plan, with the goal of accounting for a future transit system and addressing density, roadways, congestion, and other infrastructure needs.

The County Planning Board has two more work sessions scheduled for the Gaithersburg West master plan: May 28 and June 1. The sessions can be seen live and in recording here.

Celera Closing Its 41K-Sq. Ft. Outpost in Rockville, MD

Celera is shuttering its last remaining operation in Maryland's Montgomery County — its 41,000-square-foot operation in Rockville, Md., which is set to close by the end of the third quarter.

The company will lay off 20 of its 25 employees in the region, leaving only a handful of employees in the Rockville site that was Celera's headquarters until last year, when the company moved to Alameda. Only one or two employees might stay in Rockville, while the rest, working on lung cancer diagnostic tests, could move to the West Coast, the newspaper reported.

At its peak in the region, Celera employed 550 people and maintained a 220,000-square-foot HQ facility, making the company one of Maryland's largest life sciences companies.

Citing Market Conditions, UBS Downgrades BioMed Realty Trust from 'Buy' to 'Neutral'

UBS downgraded its rating on shares of life-sci property owner BioMed Realty Trust, the San Diego-based, publicly traded real estate investment trust, from "buy" to "neutral," citing concern by investors about the company's vulnerability to the finances of its tenants, as well as additional concerns.

Specifically, UBS cited what it projects will be difficult market conditions as BioMed Realty leases up new space and pursues tenants for existing properties, given both the biotech industry's financial crunch and the broader economic upheaval of recent months. UBS also cut its estimated target price for company shares to $11 from $14.

Shares of BioMed Realty fell 11 percent the day the downgrade was announced May 27. Two days later, the price rebounded to $9.92 in mid-afternoon trading.

Baltimore Bank Wins $50M in New Market Tax Credits for Pair of Baltimore Biotech Parks

Baltimore bank Harbor Bankshares will receive $50 million in New Markets Tax Credits from the US Department of Treasury toward the development of the Science+Technology Park at Johns Hopkins in East Baltimore, and the University of Maryland's BioPark across the city in West Baltimore.

The credits were among $1.5 billion in tax credits awarded to 32 organizations nationwide, and paid for through the $787 billion American Recovery and Reinvestment Act, the measure signed into law by President Obama with the goal of stimulating the nation's economy.

Quintiles Marks Grand Opening of New Durham, NC, Headquarters

Executives of Quintiles, led by its Chairman and CEO Dennis Gillings, were joined by North Carolina Gov. Bev Perdue and Durham, NC, Mayor Bill Bell in a Thursday event marking the completion of the contract research organization's new approximately $50 million, 252,000-square-foot HQ, a 10-story building off Interstate 40 at Page Road.

Quintiles agreed to base 1,000 employees in the new HQ by 2012, in return for receiving a $23 million package of tax breaks and other incentives from the state and city governments announced in 2006. More than 400 of those jobs are already in place, company officials told local news outlets, putting the firm ahead of its six-year timetable.

Gillings' top-floor corner office features a glass door leading to the building's roof. Employees will work close to the glass walls and clustered offices within, so that more light could filter into their desks: "They make an attitudinal difference on your employees. You get a feedback cycle from that," Gillings told the Herald-Sun of Durham, NC.

Tri Properties, a Durham-based real estate development company, built the new Quintiles HQ as part of Imperial Plaza, which also included a Westin hotel.

Burnham Institute Official Discusses Goals for New Florida Digs

Florida's more than $1 billion in state and local subsidies has drawn to the Sunshine State a half dozen research institutes that are expected in return to create new jobs and economic activity beyond the tourism, hospitality, and agricultural industries that rise and fall with the economy.

The latest research center to settle into new Florida digs is the Burnham Institute for Medical Research. Over the coming week Burnham, which operates a research center in La Jolla, Calif., expects to finish moving personnel and equipment from three smaller Orlando sites to a new $85 million, 175,000-square-foot building within the 600-acre 'Medical City' science and technology park.

The Medical City is part of the 7,000-acre Lake Nona mixed-use, master-planned community in Orlando, developed by the Tavistock Group of Windermere, Fla.

Burnham is bringing to the new facility the 75 staffers currently employed at its Florida locations, and the institute says it is on track to grow its headcount this year and next. Indeed, as part of its relocation agreement, Burnham agreed in 2006 to employ at least 303 people at Lake Nona within 10 years, in return for its $310 million package of state and local government incentives.

The package consists of $155 million from Florida's $250 million Innovative Incentive Fund, eliminated last year in a budget-cutting move [BRN, May 5, 2008; http://www.genomeweb.com/bioregionnews/florida-facing-2b-budget-shortfal... ], and an equivalent sum from several local sources: $31 million toward building costs from the city of Orlando; $30 million in tissue donations from Orlando Regional HealthCare System and its Florida Hospital; $25 million from the University of Central Florida; and $20 million from Tavistock Group toward site and construction costs.

Within the new building, Burnham investigators plan to study diabetes, obesity, and heart disease. The institute hopes to generate additional news later this month, at the BIO 2009 International Convention, when it anticipates making what Burnham Institute for Molecular Research at Lake Nona spokeswoman Deborah Robison called "an important announcement regarding a very exciting hire."

Burnham is the first institution to open its permanent facility within Medical City. Set to join Burnham in the sci-tech campus will be:

The University of Florida, which has announced plans for a $62 million, 100,000-square-foot research and academic/conference facility adjacent to the institute;

UCF, which has almost completed its $99 million, 198,000-square-foot Burnett School of Biomedical Sciences and still constructing its $68 million classroom building and medical library for the new College of Medicine, set to be completed in 2010 though the college will welcome its first med students in 86 days, according to a countdown clock on its web site. Both facilities are within UCF's Health Sciences Campus; http://www.med.ucf.edu/

MD Anderson Cancer Center, which will relocate its Cancer Research Institute into 30,000 square feet of fifth-floor space it has agreed to lease at the five-story Burnett building from UCF, while it completes planning for a permanent facility;

Nemours Foundation, which on Feb. 25 broke ground on a $400 million, 620,000-square-foot children's hospital with 95 beds, set to open in 2012; and

The US Department of Veterans Affairs, which broke ground in October 2008 on a $656 million VA Medical Center to consist of a 134-bed hospital, a 118-bed nursing home, a 60-bed residential rehabilitation center, eight operating rooms, two cardiac catheterization laboratories, an outpatient clinic, and a veterans' benefits mini service center. The med center is also to open in 2012.

BioRegion News spoke on Thursday with Cyril Doucet, vice president of operations and administration for Burnham Florida, about the institute's move into its Lake Nona facility, and its research focus in Florida. Following is an edited transcript of that interview.

How far along is Burnham's move to its permanent facility?

We've moved everybody in to the new facility here, and we're just settling in and unpacking, and we're testing and calibrating some equipment, and some of the systems in the building. We should be okay next week, which is about mid-May. [Researchers] are already in some cases starting experiments, and starting to feel at home.

What's your target day for finishing up?

It's one of these things where it's hard to pick a specific date. It's not like a manufacturing facility, where we're going to flip a switch, and everything's going to start running. We basically are by mid-May, I would say that by the 15th [or] 16th of May, everything will be up and running.

Has equipment been mostly or entirely been moved, at this point?

Yes, that's correct. It hasn't all been tested, and calibrated, and hooked up. But it has all been moved in.

The cost of the move has been reported to be $100,000.

Yes, that's correct. That's the cost of the move [as charged by] the various vendors and moving companies that we used. We had a situation where we had about 15 specialty vendors. In our case, we were moving some very specialized equipment that had been manufactured by Nikon and Olympus, particularly microscopes. So there were a number of vendors that were involved in coming in, and packing up their equipment, and then taking it over here. Plus we have the regular move agent that we used to pick up all of our belongings, and a lot of the supplies, and administrative files, and a wide variety of computers, and that sort of thing.

Our equipment included different robots, a half-million-dollar confocal microscope, microfluidic machines. We had biological material — the scientists were doing experiments, and then they had to plan for this move. So in preparation, one of our scientists froze 10 million cells as a backup to what was going to be moved, had that down as minus 346 [degrees Farenheit] in liquid nitrogen, and then even as a double backup, he took two million of those cells and FedEx'd them to his collaborative partner at a university.

How many people made the move?

There were 75 of us who moved from a couple of locations in Orlando. Most of us were at the fourth floor of the Florida Blood Center, but there was a number of administrative staff who were located next door to the blood center, in a building called the Liner Building, and we had a few people in downtown Orlando. Now, what's really good about this is that we're all in the same place, and able to make our connections, and get up and running.

What will happen to the blood center space? Will Burnham hold onto that or give it up?

We'll give it up. As far as Burnham is concerned, two years ago we moved into the fourth floor, and we were two guys sitting in a box, trying to figure out how to pick up the phones. And over the intervening two-year period, the fourth floor was renovated to make it lab-ready. Then we recruited and on-boarded a number of scientists.

We're leaving it in a condition that Florida Blood Center can use it for wet lab space. I believe that they have been discussing with the Orlando Economic Development Commission a possibility of using the space as incubator space for small companies, for those that are interested in starting up in Orlando. We renovated 10,000 square feet into wet lab space on the fourth floor, at a cost of about $2 million in 2007. We used it for two years, and now it's available for others to use.

How closely did the move hew to your schedule?

Well, it was on budget and on schedule. We had always anticipated completing construction around the end of March, or beginning of April, and then being in the building in the spring. Some of the state benchmarks said that they had hoped we would get in, or wanted us to get in by 2010. We're actually in by 2009. In that sense, we finished ahead of schedule. But in terms of the contract that we signed with Lake Nona Corporation and B&K Construction, we signed a contract that was brought in on budget and on schedule.

What brought Burnham to Lake Nona and its 'Medical City' in the first place?

There was a variety of criteria that came into play. There was an incentive program from the state of Florida that was very attractive. I think the location at the Medical City was in and of itself a great incentive, and a great attraction, to have the opportunity to be in a location enabling us to collaborate so closely with universities — the two universities being Central Florida and the University of Florida, with the VA, with Nemours, MD Anderson.

[We liked] the location of the Medical City, the incentive program, the kind of community support we found, and the sort of can-do entrepreneurial spirit that certainly the leadership of Burnham saw when they first came here. And also, I think Orlando, being in central Florida, presents a very attractive place for an organization to locate. It's accessible to one of the best and largest airports in the United States. There's a terrific lifestyle, and accessibility to affordable housing here in central Florida, which helps us in terms of recruiting the best and the brightest for our organization. Those are the elements that were in play when Burnham was going national and trying to asses where it was going to locate. I just think it was a great decision, and one that's going to work out well both for Burnham and central Florida.

You mentioned recruiting the best and the brightest. To what extent will you be recruiting people to fill Burnham's remaining positions, and to what extent will the institute be able to develop talent locally through education?

In terms of our investigators, the plan is to hire 30 faculty level investigators who basically lead research programs. And these investigators potentially are the ones that will draw in the grant support that will allow us to become completely self-sustaining. Those investigators we recruit nationally, both in terms of trying to attract established researchers, as well as young up-and-coming scientists.

Those labs then, in turn, hire postdoctoral fellows, research technicians, and associates. And we also have a variety of research support staff and administrative staff. At that level, we would tend to recruit locally, if possible. It provides us with the opportunity — again, one of the reasons why central Florida was interesting and attractive was because it provides us highly qualified people from a variety of sources.

We expected at this point in time to have about a half dozen investigators on staff, and we're now already at double that, at 12. So we anticipate being over 100 people by the fall, and close to 130 people by the summer of 2010, and within the next seven years, we expect to reach our target of 300 staff in the building, and we even expect to even do better than that.

How many of those staffers will be investigators hired this year and in 2010?

Our target in 2009 into 2010 is to hire another four investigators, and we already have 12 on staff.

How far along is the local recruitment effort?

We recruit. We post our positions on our web site. We have reached out to the universities and colleges to establish contact, so that they're aware of when we put up our positions. We've been very fortunate that, partly because of the interest in Burnham, a little bit hopefully because of our name, we have had excellent response in our recruitment locally.

What effect has the state of the economy in the last few months had on finding people?

I think it's clear that we've been getting larger than anticipated response. We've had a very good response, but I think we're getting an even stronger response because of the local economic conditions on our local positions.

On the scientific level, in our recruiting for scientists and faculty, I don't think it has had that much of an impact, because we're basically making our search countrywide.

Burnham has said diabetes, obesity, and heart disease will be its areas of research focus of its East Coast campus in Orlando. Is the East Coast more suited to this work than San Diego because of a particular partner, or population?

No, I don’t think that has really anything to do with that. The selection of that theme had more to do with just the general issue that really has arisen over the past five to 10 years as the next big thing. It's also an area that's very complementary to the programs that Burnham has already set up in cancer, and neuroscience, and allergic diseases in San Diego. I think it has more to do with the population as a whole, and a view of what the next epidemic is that we need to address, as opposed to anything specific about Florida.

The East Coast move was driven by wanting to have access to collaboration opportunities with the East Coast universities and organizations, and also to be able to draw on the scientific talent on the East Coast. And I think the motivation [for opening the facility] in Florida was what Florida offers, and offered Burnham as a location on the East Coast. It flowed that way more so than a disease-related issue. The theme was picked because of its importance nationally.

As the Lake Nona facility grows, what effect will that have on Burnham's San Diego labs?

San Diego has basically been growing itself. As [Burnham President and CEO] Dr. [John] Reed has often said, a rising tide lifts all boats. There is a strategic plan that's been approved by the board of trustees for Burnham that sees growth in San Diego in the areas of cancer, neuroscience, and infectious diseases programs, as well as childhood diseases. There has now been a new center that has been opened in San Diego to address that. These are complementary efforts, but certainly Lake Nona is going to be an opportunity to grow on its own, while still collaborating effectively with the mother ship in San Diego.

Our Diabetes and Obesity Research Center is complementary to the four centers of study in La Jolla. But in addition, there are these collaborative efforts [between researchers at both Burnham campuses] that take place. Since this summer, we have the Conrad Prebys Center for Chemical Genomics; it has a base currently in La Jolla, and we're in the process of establishing the screening center here at Lake Nona. And that will be occurring this summer, where we bring in probably the most advanced high throughput screening resources that are available — it's virtually unprecedented for an independent not-for-profit research institute to have this type of equipment. There will be a three-pod, highly flexible robotic screening system for small molecule screening — basically $12 million worth of robots and support services — in our new institute at Burnham Lake Nona here.

When we look at what is coming up ahead, the robot pieces start to get delivered in just a few weeks, and we'll be working on that, and having that center up and running by the end of the summer. There's an example of where there will be collaborative research in the chemical genomics area between Lake Nona and La Jolla, because the center has bases at both campuses.

This is a collaboration between Burnham's East and West Coast campuses. Are there partners from other institutions involved?

We will be doing screening for assays and investigations that are led by Burnham PIs as well as externally. This will be done through one of the biggest NIH grants ever awarded, $98 million. Investigators would apply to NIH for screening funding, and then NIH assigns them to go to one of the four approved comprehensive centers in the US, of which Burnham is one. We will be doing that screening for external PIs.

Another opportunity for collaboration is right here in Orlando, the institute has established a partnership with Florida Hospital regarding a clinical research institute for studying diabetes and cardiovascular disease. Burnham looks at disease at a molecular-cellular level. We really need to have a process by which we take our information, and our discovery, and translate it through into clinical activity. And here's a great opportunity to collaborate with a health provider like Florida Hospital, which is establishing its own clinical research institute. There will be a connection from pretty much the bench to the bedside.

That's the kind of example of what we're trying to establish in Orlando. And it does have connections to Burnham in San Diego, because there are researchers there that are looking at diabetes, and have projects that are relevant to the theme that is here. We also have a connection here between a scientist working here at Burnham and the Harbor branch Oceanographic Institute. We're trying to create synthetic anti-cancer compounds by understanding some of the natural compounds that come from the sea.

Sanofi Lands $190 Million Swine Flu Contract

Sanofi Pasteur has landed what it believes will be the first of a series of orders from the US Department of Health and Human Services (HHS) to produce H1N1 vaccines.

New incidences of swine flu continue to occur around the globe, with the World Health Organization saying that there have been 12,515 cases in 47 countries, with over 90 people believed to have died after contracting H1N1.

Consequently governments are remaining vigilant and the HHS has used its existing pandemic stockpile contract with Sanofi to place a $190m (€136.5m) order, which will cover the production of bulk vaccine and related activities.

Sanofi is still waiting to receive the seed virus from the US Centers for Disease Control and Prevention (CDC) but is confident that its experience and knowledge will enable it to act quickly when the material is supplied.

Wayne Pisano, president and CEO of Sanofi Pasteur, said: “Production of a new vaccine is not a simple task and there are a number of necessary and complex steps that must be taken before a vaccine can be made available to the public, but we have experience on our side.

“Previously, we developed and licensed the first pre-pandemic vaccine for H5N1 and we look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from A(H1N1).”

When Sanofi receives the seed virus it will commence development efforts, with commercial production planned for June. Production will initially occur in one of Sanofi’s facilities in Swiftwater, Pennsylvania, with the other plant in the town being converted to H1N1 manufacture at a later date.

Pisano emphasized the benefits of being able to switch between different vaccines at production plants, saying: “Our philosophy is to maintain flexibility in our influenza vaccine production, to enable us to answer public health needs wherever they are. We know that seasonal influenza remains a global threat and, in many countries, especially developing countries, H5N1 is still a greater threat than A(H1N1).”

Wacker Expands Cyclodextrin Capacity

Wacker has brought its expanded cyclodextrin facility online following its $21m (€15m) expansion, which has significantly increased capacity in response to growing demand for the excipient.

Cyclodextrins have applications as stabilizers and excipients in the pharma industry, with their structures enabling them to bind ingredients, release active agents and stabilize sensitive substances.

To meet rising demand Wacker has invested $21m in its Eddyville, Iowa, US facility, boosting capacity for alpha and beta cyclodextrins by 50 per cent and doubling its output of the gamma version.

Gerhard Schmid, president of Wacker Fine Chemicals, said: “Eddyville’s expansion program is a further step toward strengthening our position as global market leader for cyclodextrins. Thanks to the site’s expansion, we are now well positioned to not only reflect global market and demand trends, but also to meet growing customer needs.”

The expanded facility will be capable of producing 7,500 metric tons of cyclodextrin a year and includes a byproduct-processing plant that will cut steam use by 35 per cent.

Wacker has also opened a new process development building dedicated to the production of proteins for use in the pharmaceutical sector.

The facility in Jena, Germany covers 1,700 m. sq. (18,292 sq. ft.) and now has the capacity to produce double-digit gram quantities of highly pure proteins for preclinical use.

Another expansion of the Jena site, which will double production capacity in the existing good manufacturing practice (GMP) compliant plant and add a downstream purification site, is expected to be complete in early 2010.

After completion of the expansion Wacker believes that it will have “sufficient capacity for commercial production of biopharmaceuticals right at the advanced development stage”.

Small Businesses to Get $5M-plus in NIH Stimulus Funds

The National Institutes of Health plans to grant at least $5 million in stimulus funding to fuel development of high-risk and high-reward biomedical research in small businesses.

Funded under the American Recovery and Reinvestment Act, the "Small Business Catalyst Awards for Accelerating Innovative Research" program will award between 20 and 25 grants of around $200,000 in fiscal 2010.

The goal is to fund projects that aim to "generate high impact results," NIH said in a funding announcement, and innovative research tools, techniques, devices, inventions, or methodologies that will improve public health, as well as create value and contribute to economic stimulus.

These "transformative" research approaches should address "major biomedical and behavioral challenges" that have the potential for commercial development, according to NIH.

NIH wants to "strongly encourage" programs that are not likely to be undertaken by academic programs or in industrial forms. The institutes also want to use the funds to encourage technologies that stem from "an emerging scientific field or technological capacity that would be beneficial if successfully commercially developed."

The program also is aimed at "promising small business concerns" that have not received previous NIH funding, and to provide them "an entrée to the NIH research portfolio," NIH said.

Applications for this funding program are due Sept. 1, with anticipated start dates in April 2010.

REST OF WORLD

AMRI Completes R&D Facility in Hungary

AMRI announced that it has finished the construction of a new state-of-the-art chemistry R&D facility in Budapest, Hungary. The successful completion and move into 32,300 square feet (3,000 square meters) of laboratory and administrative space marks a significant milestone in the company’s plan initiated in 2008 to transform its European hub into a higher value discovery services business through consolidation of multiple locations, equipment and operating costs.

In addition to the significant improvements in operational efficiencies and enhanced technology transfer, the new site provides capacity for the anticipated expansion of synthetic chemistry services, currently projected to double over the next five years.

Figuring prominently in the mix of services will be expanded offerings in parallel synthesis and medicinal chemistry, and the establishment of fragment-based drug discovery. The facility also includes a scale-up laboratory for non GMP synthesis for batch sizes up to 25 liters.

“The successful completion of this expansion increases the ability of AMRI to execute on its strategy to accelerate growth and expand its presence in the European marketplace,” said Chairman, CEO and President Thomas E. D’Ambra, Ph.D. “Critical to the decision to undertake this project was the company’s drive to cultivate a customer base relatively untapped. We believe this latest investment, along with our parallel investments in the US, India and Singapore, will further strengthen AMRI’s presence as a premier provider of a broad range of scientific services, capabilities and geographic choices around the globe.”

Helsinn Plans High-Potency API R&D and Manufacturing Capacity to Swiss Facility

Swiss drugmaker Helsinn has unveiled plans to add high-potency API R&D and manufacturing capacity to its facility in Biasca in the south of the country.

The plan will see Helsinn expand development and manufacturing services in a bid to capture a share of the growing market demand for potent active pharmaceutical ingredients (APIs).

Company CEO Riccardo Braglia explained that: "The new organization of our R&D and production facilities in both Switzerland and Ireland represents one of our corporate strategic goals and is of significant benefit for the further growth of our international business."

The move follows just weeks after the Biasca facility gained ISO 14001, OHSAS 18001 certifications for the development and manufacture of APIs for the drug industry following a May inspection by accreditation group SGS International.

At the time, Paolo Guainazzi described the certifications as an important step for the firm and a vindication of its decision to invest around €5m ($7m) to raise quality, safety and manufacturing standards at the plant.

Helsinn Ireland Sold to Medinco

Helsinn also confirmed that, as part of ongoing reorganization efforts, it has signed an agreement to sell its Irish manufacturing plant in Mulhuddart, Dublin to Italian pharmaceutical chemicals supplier Medinco for an undisclosed sum.

The year so far has been a busy one for Helsinn’s executive team. In January, the firm set up a base in US pharmaceutical hub New Jersey with the acquisition of Sapphire Therapeutics.

Speaking at the time Braglia explained the Sapphire purchase would “allow [the firm] to expand our current pipeline of products in existing, focused therapeutic areas in particular in cancer supportive care.”

He went on to say that the unit would act as both an R&D and commercial operations centre for the firm’s burgeoning North American business.

This was followed in March by Helsinn’s investment of €13m ($18m) to set up an R&D centre of excellence for oral solid-dose drugs at a second facility in the Irish capital Dublin, creating 10 new high-tech jobs.

Genome Sequencing Center Opens in Dublin

Trinity College Dublin's Institute of Molecular Medicine has opened Ireland's first Genome Sequencing Laboratory, the university recently announced.

The new lab, which opened within the past couple of weeks, will enable research into psychiatric disorders, cancers, infectious diseases, and immune system disorders being conducted at the Institute of Molecular Medicine. Funding for the sequencing lab was provided by Science Foundation Ireland through a grant of €557,724 ($773,680).

The university claims that the new lab also houses Ireland's first next-generation sequencing platform — an Illumina Genome Analyzer II.

"This new DNA sequencing technology will greatly accelerate the search for risk genes for schizophrenia by enabling Trinity's Neuropsychiatric Genetics Research Group to sequence many genes in many patient samples to identify the subtle changes to the DNA code that results in a gene not functioning properly and thus contributing to the development of the illness," said Professor Michael Gill, head of the Neuropsychiatric Genetic Research Group in Trinity's School of Medicine.

CROs Expand in Africa / Quintiles Transnational in Accra, Ghana; Synexus in South Africa

UK CRO Quintiles Transnational has set up an office in Accra, Ghana in a move it claims allows it to recruit trial participants from sub-Saharan Africa’s estimated 760m residents.

The pharmaceutical industry’s growing demand for treatment naive populations has seen contract research organizations (CRO) enter various new markets in recent years, with Asia, South America and Central and Eastern Europe being the key beneficiaries.

This month alone US CRO Kendle has set up offices in Malaysia, Thailand and the Philippines while compatriot PRA bolstered its presence in Brazil.

In addition, the Russian trials sector has attracted a lot of attention most recently on June 2 when a Synergy Research Group report described it as a “potential superpower” in the market in years to come.

Africa too has benefited from the CRO sector’s expansion with, for example, patient recruitment specialist Synexus announcing plans to double its South African trial capacity in December.

In February, the European Union provided €3m ($4.15m) funding for a network to promote excellence in clinical trials through its European & Developing Countries Clinical Trials Partnership (EDCTP) unit.

CEO in Africa, Corken said that: “Initially the focus will be on diseases such as malaria, TB and HIV,” such as the trial of a malaria vaccine that the firm recently began.

“However, we anticipate that as the infrastructure and economies in Africa develop… it will play an increasingly important role in recruiting patients for many other therapeutic areas, such as oncology and cardiovascular.

Quintiles’ Accra office is based in the grounds of the University of Ghana at the Noguchi Memorial Institute for Medical Research.

In addition to managing its local trial activities, Quintiles office will provide training for new investigators across a range of therapeutic areas, as well as an education program for clinical research associates (CRAs).

Quintiles also stressed that, as with its other units worldwide, its Ghanian office will “strictly adhere to ethical principles articulated by international guidelines such as ICH, the Declaration of Helsinki, CIOMS and the Belmont Report.”

The firm’s emphasis on the ethics is perhaps unsurprising given some recent criticism of practices employed during trials in Africa, most notably Pfizer’s Nigerian Trovan study, and throughout the developing world as a whole.

Vetter Expands Secondary Packaging Capacity

German aseptic filling specialist Vetter has boosted packaging operations at its new facility in Ravensburg to meet growing demand for cost-effective secondary packaging services

The firm installed six new fully automatic production lines at the plant, doubling capacity for everything from aseptic-filling, pen assemblies and auto-injectors to labeling and blister packaging.

Company managing director Thomas Otto explained the rationale for the new unit, suggesting that increasing economic and regulatory pressures had made secondary packaging a critical issue for the firm’s customers.

Aseptic filling is one of the areas that has seen the most growth in the pharmaceutical outsourcing sector in recent years as drugmakers keen to enter the lucrative markets have sought ways to reduce the cost of such operations.

The Ravensburg plant, known as Vetter Secondary Packaging (VSP), has been in development since 2006, with construction being completed late last year. Since then Vetter has been working to install and validate the new packaging lines.

“What makes VSP particularly advanced is the complete automation of all steps on the finishing lines, including labeling, plunger installation, blistering, packing and transport from one station to the next.” Otto added that: “Compared to conventional procedures, VSP allows twice the number of systems to be assembled in half the time.”

Vetter also claims that the facility’s hygienic manufacturing area, which complies with good manufacturing practice (GMP) specifications, provides optimal conditions for pharmaceutical finishing.

The plant is part of Vetter’s recent efforts to expand its pharmaceutical industry offering. In March the firm set up a new subsidiary, Vetter Pharma International (VPI) to take charge of sales, marketing and customer services.

Luminex Launches Test Kits

Luminex said that it has launched its xTAG cystic fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2 as CE IVD Marked products in Europe. The multiplex tests screen for common CFTR gene mutations and for additional mutations that are typically found in specific ethnic populations.

Mexican Ministry of Agriculture Orders from AmpliBio

The Mexican Ministry of Agriculture has ordered 17 GeneLABs for molecular analysis from AmpliBio. Each system will contain Advalytix's AmpliSpeed single cell molecular analysis cycler, and Implen's nanophotometer for quantifying DNA, RNA, and proteins. AmpliBio also is supplying the Mexican Institute for Epidemiology with nanophotometers to increase the institute's capacity to screen for H1N1.

Millipore Opens New Facility in Danvers, MA

Millipore has opened a new 30,000-square-foot bioprocess manufacturing facility in Danvers, Mass. The firm will produce a range of its Mobius single-use product line for biopharmaceutical manufacturing technologies at the new facility.

J. Craig Venter Institute Using Isilon IQ as Repository for Massive Dataset

The J. Craig Venter Institute is using Isilon IQ as a repository for a massive dataset of sequenced DNA samples related to JCVI's work in sequencing microbes associated with infectious diseases, Isilon said. Isilon IQ delivers more than 5 petabytes of capacity and up to 45 gigabytes per second of performance in a single file system.

DNA Genotek Partnering with Roswell Park Cancer Institute to Collect DNA Saliva Samples

DNA Genotek said that it is partnering with the Roswell Park Cancer Institute to collect DNA saliva samples on site at the Susan G. Komen Western New York Race for the Cure, in Buffalo, NY. The partners will use Oragene DNA sample collection kit. The samples will become part of RPCI's Data Bank and BioRepository.

Kemwell & Boehringer Collaborate on Biologics

CMO Kemwell is receiving technical assistance from Boehringer Ingelheim for the construction of its new biotech facility, which is designed to marry European technology with Indian low cost manufacturing.

The facility in Bangalore, India will use process technology from Boehringer, which should simplify transfer and scale-up if clients want to use the Germany-based company’s European commercial production capacity.

Kemwell’s clients will have preferred access to Boehringer’s facilities and this, coupled to the efforts to simplify transfer, is intended to help clients reduce time to market.

Use of Boehringer’s BI HEX high expression system, which speeds the development of high-titer processes for producing biologics from Chinese hamster ovary (CHO) cells, is also expected to cut time to market for the contract manufacturing organization’s (CMO) clients.

The 15,000 sq. m. (161,400 sq. ft.) Kemwell facility, which the company plans to invest $50m (€36m) in, is designed for process development, production, purification and formulation of biologics for early-phase preclinical and clinical studies.

A current good manufacturing practice (cGMP) compliant facility and sterile fill and finish site are planned. In addition the site will house process development laboratories to support production of protein therapeutics from microbial fermentation or mammalian-cell culture.

Microbial fermentation of up to 1000L will be installed as well as cell culture bioreactors up to 2000L. Flexible downstream processing capacity is also in the plans.

For clients needing process development Kemwell is installing separate microbial and cell culture laboratories that will scale up to 80L and provide research and preclinical material using similar equipment to the cGMP plant.

In addition the site will have aseptic filling and lyophilisation capacity. This will be capable of handling fill volumes ranging from 2ml to 20ml and have a capacity of 30,000 vials per batch.

The new facility marks Kemwell’s first move into biologics, a sector that it believes is currently untapped in India.

For clients to transfer work to the country they will have to be reassured that it is capable of handling biologics, a process that Singapore put significant effort into, and Boehringer’s presence should help with this.

GlaxoSmithKline Opens Singapore Biologics Vaccine Plant, Creates Endowment Fund

GlaxoSmithKline this week opened a S$600 million ($414 million) vaccine plant in Singapore's Tuas Business Park, in the Asian country's western section. The plant will begin production of GSK's pneumococcal conjugate vaccine, designed to combat meningitis, pneumonia, and blood poisoning, in 2011 following audits from the US Food and Drug Administration and the World Health Organization.

The new 85,000-square-meter (914,932-square-foot) plant will employ about 200 people, and grow GSK's Singapore workforce, which now totals 1,000 employees. Company vice president Emmanuel Amory told In-Pharmatechnologist.com that Singapore had been chosen as the site for GSK’s first vaccine plant in Asia due to what he called its highly skilled local workforce, following a decade-long plan by the government to boost expertise in biologics.

Another possible factor is the country’s lower labor costs for manufacturing than the US, Canada, or Europe. Data issued April 1 by the US Bureau of Labor Statistics concluded that as of 2007, the hourly compensation for manufacturing employees in Singapore was half that of their American counterparts.

During the June 9 opening ceremony, GSK CEO Andrew Witty called the plant "possibly the best vaccine facility anywhere in the world," while Singapore Prime Minister Lee Hsien Loong said it marked a significant victory for the republic, which has sought to dominate drug manufacturing within Asia, the Straits Times reported.

At the event, GSK announced that it was setting up a S$30 million endowment fund for graduate studies in sustainable manufacturing processes, green chemistry, and health policies. The prime minister said Singapore would chip in another $20 million to the fund, which he termed a symbol of cooperation between GSK and Singapore.

GSK Grows in Asia Vaccine Market

UK drug major GSK has had a busy week in the Asia, signing an influenza vaccine manufacturing deal with China’s Shenzhen Neptunus Interlong Bio-Technique just days after it opened a new S$600m (EUR294m) production facility in Singapore.

The Shenzhen joint-venture (JV), which will see GlaxoSmithKline (GSK) pay $34m for a 40 per cent share, will develop and manufacture influenza vaccines, both seasonal and pandemic, for the Chinese, Hong Kong and Macau markets.

Under the terms of the agreement GSK, which plans to acquire a controlling stake in the business over the next two years, will make its established adjuvant technologies available to Shenzhen for further R&D and commercial vaccine manufacture.

Jean Stephenne, president and general manager of GSK Biologicals, said the alliance “enables GSK to build new vaccines capability in a critical emerging market such as China.”

Stephenne highlighted the improved access to locally-circulating influenza virus antigens as one of the key benefits the partnership with Shenzhen will provide.

With the World Health Organization (WHO) poised to declare H1N1 “swine flu” a pandemic, GSK’s renewed focus on vaccine production for markets in one of the world’s populous regions is well timed.

WestLB analyst Simon Mather told Reuters that the deal is a further example of GSK CEO Andrew Witty’s desire to grow in emerging markets. In May, the firm bought a 16 per cent stake in Africa’s largest generics firm Aspen Pharmacare.

The day before announcing the China JV, GSK showcased a new S$600m vaccine production facility in neighboring Singapore.

The 85,000 sq. m. plant (914,600 sq. ft.), which is located in the Tuas Business Park in the west of the country, will be used to make GSK’s pneumococcal conjugate vaccine when fully operational in 2011.

Company vice president Emmanuel Amory said Singapore had been chosen as the site for GSK’s first vaccine plant in Asia due to the highly skilled local workforce, which is a result of the government’s decade long policy of developing biologics expertise.

Singapore’s science talent pool has been attracting many major Pharma industry players in recent years with Bayer, Schering-Plough and Takeda all expanding their operations in the country.

More recently Swiss biomedical science group Lonza unveiled plans to build on its Singaporean presence and set up a CHF30m (€19.7m) cell therapy manufacturing plant in the country.

MDS Expands Taiwan Capacity in Early Stage Focus

MDS Pharma Services is renovating and expanding its Taiwanese discovery pharmacology operation in response to growing global demand for work performed in Asia.

The overhaul is part of MDS’ increased focus on early stage research, which was demonstrated by the sale of its late stage trial unit to INC research, and is due to be completed in 2010.

MDS’ expansion will double the site’s in vivo safety and efficacy testing capacity, with space tailored to an individual client’s needs, and upgrade and expand its molecular screening and profiling services.

This includes the installation of additional robotic high-throughput screening capacity and analytical support, which MDS believes will improve the site’s automated molecular screening and profiling capability and efficiency.

David Spaight, president of MDS Pharma Services, said: "This new and expanded facility will cement our position as the global leader in the discovery pharmacology space, where we are one of the top two providers of molecular screening, and a key supplier of in vivo efficacy and safety testing.

"This investment builds on a 40-year track record of success in this service area, and supports our recently announced strategic focus on the discovery through Phase IIa proof-of-concept segment of the outsourcing market."

The Taiwan facility forms part of MDS’ Pharmacology/DMPK (drug metabolism and pharmacokinetics) services, which offers molecular, cellular, ADME (absorption, distribution, metabolism, and excretion) and in vivo assays.

Clients can use these services to help identify drug candidates, profile for selectivity, assess potential for adverse events, evaluate efficacy and establish proof of concept.

MDS believes that clients using these services can “help speed lead optimization earlier in the discovery phase and streamline the surest path to the clinic”.

Patheon's Swindon, UK facility Extends Its Aseptic Vial-filling Capabilities

Patheon's Swindon, UK facility has extended its aseptic vial-filling capabilities to include the commercial supply of small-scale specialty products. The facility recently received FDA approval at Swindon, allowing the company to provide clients with a seamless service, where development batches and commercial product can be supplied from the same filling line. This new capability is now operating at the Swindon site for vial sizes ranging from 2mL to 30mL, and allows for the use of disposable components.

Wes Wheeler, president and chief executive officer of Patheon, stated, "We can now produce commercial product from the same production line that is used for Phase II and Phase III clinical batches. This allows clients to commercialize their drugs much faster than would normally be expected."

GlaxoSmithKline and Shenzhen Neptunus Interlong Bio-Technique Form a Joint Venture Manufacturing Vaccines for Chinese Markets

GlaxoSmithKline and Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. have entered into a definitive agreement to form a joint venture focused on developing and manufacturing flu vaccines for the Chinese market.

Jean Stéphenne, president and general manager of GlaxoSmithKline Biologicals, said, “This new alliance enables GSK to build new vaccines capability in a critical emerging market such as China. The new joint venture will combine the potential of GSK’s adjuvant technology and expertise in vaccine development together with the extensive experience of Shenzhen Neptunus in the Chinese vaccines market. Together we will gain access to specific local influenza antigens and make available new vaccines to benefit public health in China and neighboring territories.”

The alliance will develop and manufacture influenza vaccines for China, Hong Kong and Macau that will include vaccines for seasonal, pre-pandemic and pandemic influenza. These vaccines are expected to become available during the next few years. GSK will provide access to its adjuvant system, which helps to improve efficiency and optimize production by increasing the number of vaccine doses that can be produced using a smaller amount of antigen. Shenzhen will provide additional local manufacturing capacity and R&D expertise. Both companies will provide further investment in manufacturing.

GSK will take a 40% stake in the joint venture, contributing $33.5 million in cash and assets. Shenzhen Neptunus will take a 60% stake equivalent to $49.4 million. Under the terms of the agreement, GSK is expected to purchase additional shares and obtain a majority equity interest in the joint venture within the next two years.

Corden Cuts Manufacturing in Cork

Ireland’s API manufacturing sector suffered a blow with Corden Pharmachem’s announcement that it is phasing-out manufacturing at its facility in Little Island, Cork.

Corden has predominantly used the plant for the contract manufacture of actives for drug industry clients but does carry out some R&D activity at the site.

The decision to halt manufacture, which will result in the loss 90 active pharmaceutical ingredient (API) production jobs according to a report in the Irish Times, is in response to the “substantial losses” operations at the facility has incurred in recent years.

Corden said that: “The limited potential for the development and commercialization of new products, the scale of the plant and the significant capital investment necessary for it, the Cork operation is no longer viable."

The firm added said it will begin winding down manufacturing operations in the autumn but added that it will maintain its R&D operations at the site with a staff of seven or eight research scientists.

Corden's Little Island facility was in the headlines in May last year after a fire at the plant caused the death of one of the firms workers. At the time the company temporarily laid-off 61 employees and suspended manufacturing operations.

Ireland’s biotechnology sector has been something of a rollercoaster in recent years with news of facility openings and closures alternating on a seemingly monthly basis.

The API sector looked to have suffered a major blow last summer when Pfizer decided to halt production operations and seek a buyer for its facility which, like the Corden plant, is located in the Little Island manufacturing hub.

However, Pfizer’s facility was eventually bought by Portuguese chemicals firm Hovione, which re-opened at as an API manufacturing base in April joining rivals like SAFC and Helsinn, which both operate in the region.

It is this kind of competition, coupled with fluctuations in demand for the contract production of APIs, that makes Ireland an increasingly difficult base from which to operate and compete with the Asian manufacturing sector for some of the industry's smaller players.

Sanofi Buys Pfizer Insulin Plant, Cancelling MannKind's Bid

Sanofi Aventis will pay Pfizer €30m ($41m) for a former Exubera manufacturing plant in Frankfurt-Höchst, Germany that was due to be bought by inhaled insulin specialist MannKind.

The French drugmaker said the facility, one of the largest of its kind in the world, will produce its Lantus SoloStar (insulin glargine) diabetes treatment, sales of which increased nearly 28 per cent to $2.45bn (€1.75bn) last year.

Pfizer, which has been seeking to sell the plant for several years following the market failure of its inhaled insulin product Exubera, agreed a sale with California, US-based MannKind in March.

The deal hinged on MannKind gaining manufacturing approval from operator Infraserv and, crucially, approval by Pfizer’s original Exubera co-developer Sanofi, which retained a “right of first refusal” option on the plant.

Evidently, gains made by Lantus in the SoloStar pen format coupled with growing worldwide demand for diabetes treatments, the World Health Organization predicts that more than 350m will develop the condition by 2030, convinced Sanofi to exercise its option.

In a press statement Martin Stewart, general manager of Sanofi in Germany, said: “The strong increase in demand for our insulins, and especially Lantus, drives us to considerably extend our production capacities.

“In combining the acquired Diabel site with our existing plants Sanofi-Aventis will operate the largest insulin capacity in the world in Frankfurt,” Stewart continued.

The acquisition fits with Sanofi’s ongoing efforts to “double Lantus sales by 2012.” In April, the firm said it that it will invest $90m (64m) over the next three years to boost Lantus manufacturing capacity in China.

According to some observers MannKind, which is yet to issue a statement on the Sanofi deal, may be less disappointed about the “loss” of the plant itself than it is about the regulatory benefits the acquisition would have provided.

When MannKind signed its original acquisition deal with Pfizer in March, Rodman & Renshaw analyst Jason Butler said that the manufacturing capacity provided by the facility was not the key motivation for the deal.

Instead, he suggested that the insulin inventory MannKind was due to gain and the license to make insulin for pulmonary delivery that it was required to obtain under the original terms would be of more benefit for MannKind.

If this reading of the situation is accurate, the fact MannKind still obtains EUR3m worth of insulin regardless of the Sanofi deal, will be seen as positive for the US firm.

Positive Ph III Afresa data boosts share price

The response to data from the latest Afresa trials reported at this year’s American Diabetes Association’s scientific sessions is also likely to boost MannKind’s spirits and alleviate any lingering disappointment.

Results from a two-year Phase III study showed that there is no difference in forced expiratory volumes (FEV) between patients treated with Afresca compared with standard insulin.

The news saw MannKind's share price climb 15 per cent to a 52-week high of $8.12 in trading on the New York Stock Exchange.

Centocor Schaffhausen Creates An Advanced Fill Finish Pilot Plant Facility

Several years ago, after determining it would not have enough manufacturing capacity to meet the future needs of its growing pipeline, Centocor in Switzerland embarked on an ambitious plan to design and build a new syringe filling facility at its Schaffhausen campus.

The design, construction and integration into the existing campus has earned the company a coveted category award for Facility Integration in the annual Facility of the Year Award (FOYA) program and has put it in the running to win the overall award announced in November.

The FOYA program, sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine, recognizes and rewards outstanding facilities from around the globe. Six facilities are selected as winners in individual categories and the overall winner is announced at ISPE's Annual Meeting in November.

Centocor Inc. is a US based, wholly owned subsidiary of Johnson and Johnson. In Schaffhausen, Centocor R&D is a division of Cilag AG and is responsible for fill finish operations and analytical testing of clinical supplies for tech transfer activities, and for marketed product support to the commercial plants.

The new R&D fill finish plant replaces an older existing facility and offers a state-of-the-art technology portfolio that mirrors the set-up of commercial facilities to ease process comparability and scale-up. The facility strengthens the strategic focus of the Johnson & Johnson global biological supply chain for clinical material and marketed products.

Centocor R&D and Cilag's team approach is one of main reasons why the facility has been so successful as Claudio Thomasin, Ph.D, Director BIO PD EU Drug Product Tech Support, at Centocor R&D Schaffhausen explains, "The excellent team work and also the management support and guidance from over the pond was certainly one of the highlights. Considering the fact that the team had to juggle two balls in parallel, manufacturing and clinical supplies in the old pilot plant, while designing, building and qualifying in parallel a brand new facility, points to the commitment, expertise and accountability of the crew."

This project was no small task as evidenced by Centocor's list of "musts" for the new facility:

• An R&D dedicated plant, fully integrated into the Cilag site campus and linked to commercial operations, QC testing and development labs and offices.

• A facility shell construction to allow addition of subsequent levels.

• High level of autonomy for utilities to minimize dependency from commercial plants and downtime schedules.

• Install fill finish equipment in a way that avoids duplication with other Johnson & Johnson plants while providing flexibility to integrate new technology to meet future needs (e.g. combination products).

• Provisions made for contained infrastructure supporting manufacturing of high potent compounds up to class OEL-3A.

• Good fit with the scale-up rationale and process comparability from lab to late stage development and commercial production.

• Integrated automation concept to minimize different types of software/hardware architecture and Human Machine Interfaces. Avoidance of complex SCADA systems to the best extent possible.

• Leveraging of existing freeze drying process equipment in old plant.

• Leveraging of campus quality standards and validation approaches.

• In-parallel phase-in/phase out concept from old facility to maintain robustness of the clinical supply chain.

To meet its needs for more capacity and incorporate its list of "must haves" Centocor constructed a new 670 m2 fill finish pilot plant facility (F2P2) on its campus. This facility produces biological drug product for early- and late-stage clinical trials and also plays a key role in the transfer of fill finish operations into a commercial plant, also located on the Schaffhausen campus.

With its capability for compounding and final formulation, vial and syringe filling, and lyophilization, this highly integrated facility provides flexibility for new product development and clinical manufacturing, as well as an efficient operational platform. The F2P2 was designed and built in a way that maximizes interactions with other key groups such as Quality Assurance, Quality Control, and commercial manufacturing.

As in many projects where new facilities must be integrated with existing facilities the company faced some challenges. One of the main challenges was the space limitations imposed by the existing buildings and their structure. While this may have posed a challenge to some, to the team at Centocor it was an opportunity for innovation, as Thomasin explains, "Most of the filling lines were integrated into the clean-room walls to save space and to provide access for maintenance outside the aseptic core. The Vaporized Hydrogen Peroxide material locker was sized and installed in a way that flexible machinery such as the syringe denester could be wheeled-in and out from the aseptic B-grade corridor. The lyophilizer loading room was designed as a classical clean-room allowing us to conduct manual fills or other aseptic activities based on less frequently used technologies, for example in the exploratory device area. The new building was interconnected by a hallway with the adjacent one, to keep offices and labs as close as possible to the manufacturing site, and, given the height restrictions of the clean rooms, most of the HVAC infrastructure was installed in the basement of the building."

The design of F2P2 posed a challenge to the company, as it required the integration and installation of many high-tech processes in a comparatively small space. The project team realized early on that while the design might look good on paper, it might not work in "real life". To assuage any fears, the decision was made to do a facility mock-up study. This effort was initiated once the preliminary layout approached its final stage for approval and prior to starting construction of the clean room and building services.

The purpose of a complete facility mockup study was to cover the entire manufacturing process at actual scale in order to anticipate unforeseen difficulties and design flaws. As Thomasin explains, this study was important for two reasons: "First, it provided the necessary comfort level to the end-user that the layout on paper will work on a day to day basis later on as well. Since everyone was concerned about the limited space, the early mock-up was "psychologically" important to get the voice of customer to the engineering department. Second, some design flaws, for example the opening of doors, size of interlocks to wheel in and out equipment without bumping into the walls or the position of benches to allow a logical material and process flow could be corrected right at the beginning."

A number of features enable the facility to be run efficiently and with a limited staff. Automation of process equipment, data acquisition and documentation retrieval all contribute to this. A single automation architecture for all process equipment and utilities simplifies running the various systems. As Thomasin further explains, balancing automation and flexibility can be a challenge, "In general, a high automation level was put into well standardized processes such as vial or syringe filling and into labor intense activities such as cleaning and sterilization, whereas non-routine operations were designed with less automation efforts. On the other hand, we wanted to keep the automation concept as flexible as possible for process adaptation and ‘last minute changes' of manufacturing parameters. Equally important was to build a standard architecture with the same PLC's and operator panels to allow personnel operating as many equipment as possible with the same process visualization features thereby minimizing training efforts and errors.

To ensure equipment operators were as well trained as possible, the Centocor team embarked on a program to train them to become Subject Matter Experts (SME's). This tactic was of key importance to the project as Thomasin explains, "Given the constraint in resources it was key to engage operators in as many aspects of the building fit-out and of process technology design and implementation. Thereby, they could gradually take over ownership and help tailor the facility to their needs. This concept ensured a high level of autonomy and minimized the dependency from support functions for troubleshooting. It ultimately added to developing everyone's skill-set and to establish a pool with broad expertise within their own department."

When asked what specific details or features he's most proud of Thomasin gets right to the point. "Condensing a broad platform of parenteral manufacturing technologies into one single facility is certainly very attractive. Also, responding to the flexibility needs of a changing R&D environment while maintaining at any time the highest levels of aseptic quality, and being asked to combine RABS technology, VHP room decontamination and classical clean room features into one footprint is certainly an accomplishment to be proud of. We are particularly pleased by this smart approach."

Finally, when asked his opinion as to why the FOYA judges chose his facility, Thomasin has this to offer, "We think we did very well in integrating a multi-product and multi-format R&D fill finish facility into a crowed campus while ensuring the shortest distances to the commercial facilities and to existing analytical buildings. The building shell was constructed in a way allowing future expansion on another 3 levels. Besides, we managed to map all relevant technologies for aseptic processing into the new facility to ensure perfect scalability, process comparability and tech transfer conditions to the commercial plants on the campus. The design was supported by computer simulations for airflow and particle distribution- thereby reducing the risk of inappropriate clean room conditions after building erection. Finally, we limited the complexity of automation whilst keeping labor intense operations at minimum. Operator safety was equally important and was an integral design prerequisite for all machinery and processes."

New Protein Center Opens at the University of Copenhagen

On the 4th June, the Faculty of Health Sciences at the University of Copenhagen opened the doors of its new research center, The Novo Nordisk Foundation Center for Protein Research. The Center is the result of a historic donation from the Novo Nordisk Foundation, which in 2007 gave the University 80 million euros for its establishment.

The protein center, headed by director Michael Sundström, is housed in three recently renovated floors of the Panum Institute in Copenhagen. With its over 150 international researchers, ultramodern laboratories and advanced instrumentation, the center will be a beacon in the field of protein research.

“With the establishment of the research center (CPR), Danish protein research will acquire working facilities that make frontline research possible,” explains Dean Ulla Wewer.

The unique construction of the center, which encourages synergistic collaboration between several disciplines, including protein characterization, proteomics, systems biology and disease biology will provide the optimal environment for the scientists and has already attracted leading international researchers to the University of Copenhagen. “The facilities are the best currently available, and as we have all the basic financing in place, our researchers are free to concentrate on their work and look forward to groundbreaking results, explains Ulla Wewer.”

By combining the study of proteins in diseased and healthy cells with the ability of computer technology to process enormous quantities of data, the center’s prospect is to uncover the causes of a range of deadly diseases and thereby contribute to the development of new and effective treatments.

“It requires profound insight into the biology of disease to develop new and targeted methods of medical treatment. Our aim is to record and understand the changes taking place in proteins that can lead to disease”, explains director Michael Sundström and stresses that the Protein Center opens up new opportunities for investigating the complicated progression from protein to disease.

The research will first and foremost benefit those whom it ultimately serves: The people who are afflicted with serious disease and for whom effective treatment is not currently available. At the same time, health science research conducted at universities and hospitals will be able to have access to a valuable resource and companies in the region will benefit from the knowledge and techniques that the center produces. Students can be introduced to the practices, methods and equipment that will prepare them for work at the highest international level.

MDS Expands Pharma Services in Asia

Consistent with its recent announcement that it would focus its MDS Pharma Services business on early-stage discovery and development services, MDS said that it has undertaken a renovation and expansion of its discovery pharmacology operations in Taiwan.

The Taiwan site offers services that include molecular, cellular, ADME/DMPK, and in vivo assays for use in identifying lead drug candidates, profiling for selectivity, determining potential adverse effects, evaluating efficacy, and establishing proof of concept. The firm said that it currently offers more than 800 assays.

MDS expects to complete the expansion in 2010. It did not say whether the expanded operations will include new hires.

, MDS said that it would sell its MDS Pharma Services Late Stage operations, which are comprised of Phase II-IV operations and Central Labs. MDS already has signed an agreement to sell its Phase II-IV operations to contract research organization INC Research for $50 million. It is looking for a buyer for its Central Labs business

Luminex Opens a New Office in Shanghai

Luminex announced that it has opened a new office in Shanghai, People's Republic of China, to serve as its center of operations in the Asia-Pacific region. The firm said that the office will include training lab space and a full-time staff, though it did not provide an expected number of employees. Luminex also has operations at its headquarters in Austin, Texas, and offices in Toronto and Oosterhout, The Netherlands.

Emerson Wins Singapore Bio Plant Contract

Industrial automation specialist Emerson Process Management has won the contract to help Swiss life sciences group Lonza design its new biopharmaceuticals plant in Singapore.

The facility, plans for which were unveiled in May, will use cell culture technologies to produce innovative biologic drugs, including monoclonal antibodies and therapeutic proteins, on a contractual basis.

Emerson has been contracted to provide engineering, digital automation architecture and process control technologies and claims that its “predictive intelligence” approach will help reduce costs, comply with regulations and meet construction timelines.

The firm previously worked with Lonza on the construction of another manufacturing plant in the country and has provided similar services for the regional life sciences operations of firms like DSM, Biocon and Shanghai CP Guojian Pharmaceutical.

Emerson president Steve Sonnenberg, said that the latest deal is an "example of how companies like Lonza can leverage our global resources and expertise to meet their objectives for safe, reliable, and on-time start-up of new manufacturing facilities."

According to Emerson the project will use its PlantWeb development platform and “the experience gained during design and construction of the original facility,” to predict and prevent any process control problems before they arise.

The firm claims that on average its approach to automation control improves the efficiency of manufacturing operations by 2 per cent in terms of throughput, availability and final product quality.

Emerson estimated that the new facility will cost around $350m (€246m) to construct and just over 12 months to complete.

Lonza will also use Emerson products like the DeltaV digital automation system; Fisher and Baumann valves; Rosemount flowmeters and analyzers; Micro Motion Coriolis flowmeters; and Fisher pressure regulators.

PRA Opens Drug Safety Centre in Brazil

PRA International has opened a drug safety centre in São Paulo, Brazil, expanding its presence in Latin America and bringing its array of services to a new market.

From the centre PRA will provide services support clients activities including assistance with US Food and Drug Administration’s (FDA) risk evaluation and mitigation strategy (REMS) and annual safety reporting.

PRA already provides these services from its sites in Charlottesville, Virginia, US and Mannheim, Germany but the company regards the opening of the Brazil centre as an important step in expanding its global footprint.

Sabine Richter, PRA’s vice president of safety and risk management, said: “The opening of the São Paulo drug safety centre enables us to expand our capabilities and level of service in Latin America and enhances our ability to provide standardized drug safety services globally, by growing and strengthening our overall safety team.

“This new centre will allow us to create cost-effective and efficient global coverage that is enhanced with a local language and regulatory knowledge base. Both are key to our continued expansion of clinical trial and post-approval delivery in Latin America and globally.”

The centre is staffed with drug safety professionals and has already commenced activities, with the team drawing on expertise from other groups in PRA, such as “analysis & reporting” and “late phase services”.

This follows the model of the existing facilities in Germany and the US, which in 2008 did more than 18,000 individual safety reports, five data integration and pooled analysis projects and contributed to three approvals by the FDA.

Kendle Expands Asia-Pacific Presence

US CRO Kendle has set up three units in Malaysia, Thailand and the Philippines, further demonstrating the growing importance of the Asia Pacific for the contract research sector.

The new offices, which are in Kuala Lumpur, Bangkok and Manila, will focus on providing contract research services for the region’s biopharmaceutical development and manufacturing sector.

Ross Horsburgh, vice president of Kendle’s global clinical development operations explained that: “With more than half of the world’s population, Asia offers an abundance of patients in nearly every therapeutic area.”

He went on to say that: “Governments have highlighted biopharmaceutical development as a key pillar to their economies, resulting in much more favorable environments for global clinical development work.”

According a recent study by the Tufts Center for the Study of Drug Development 65 per cent of all US Food and Drug Administration (FDA) regulated trials will take place outside the US, with a significant proportion being carried out in Asia.

Recognition of this trend coupled with an increasing awareness of the importance of local knowledge has seen a number of US contract research organizations (CRO), most recently Covance and PRA, invest in the region.

While the potential of the Asian trial market is clearly a motivation for Kendle building its presence in the region, the cost savings provided by the region are also a factor.

In Q1, the firm reported a 45 per cent project cancellation rate, cut its 2009 earnings expectations and said that it was examining ways of reducing costs, including expanding it network in Asia.

Growth in China’s Pharmaceutical Manufacturing Sector Seen at Gerresheimer

Growth in China’s pharmaceutical manufacturing sector fits well with the plan outlined by CEO Axel Herberg at Gerresheimer’s annual results presentation in February.

At the time Herberg suggested that: “Even in a phase of worldwide economic downturn, pharmaceutics and life science are still growth markets and, with its broad technology base and worldwide presence, Gerresheimer has a strong position here.”

Gerresheimer’s pharmaceutical division contributed 75 per cent of the firm’s total revenue in 2008 with its ready-to-fill syringes (RTF) business providing the biggest gains by growing 36 per cent.

The Gerresheimer Group opened a new plant for pharmaceutical glass packaging in China. The high-tech production facility constructed in Danyang (Jiangsu Province) covers 16,000 square meters (172,160 sq. ft.). Specializing in high-quality pharmaceutical vials and cartridges for injection systems it serves the pharma & life science industry on both a local and international level. Dr. Axel Herberg, CEO of Gerresheimer AG, describes the investment as a very important strategic step for further business expansion in Asia. In China, Gerresheimer now operates seven production plants for highly specific glass and plastic products.

The new facility belongs to Gerresheimer Shuangfeng, a Chinese subsidiary of the Group, which was acquired in 2006 and now already has production plants in three locations with a total of more than 150 production lines. With investment in future-oriented technologies and a high-quality range of vials, ampoules and cartridges, it has in just a few years developed into the market leader in China, said Dr. Max Raster, member of the Management Board of Gerresheimer AG with responsibility for the Tubular Glass Division, at the opening ceremony on May 29, 2009.

"'Top quality produced in China' is the corporate philosophy here which binds us directly to the ambitious objectives for development of the local economy and the Jiangsu region," Raster said. At the gala opening he joined Chao Xingsong, the Managing Director of Gerresheimer Danyang, in welcoming representatives from the world of politics and the administration as well as a large number of national and international customers who clearly showed they were impressed by the high technical standard.

The state-of-the-art plant in the up-and-coming city with 800,000 inhabitants just 250 kilometers to the west of Shanghai is of outstanding strategic importance for the globally active Gerresheimer Group. A key area of focus for it is the rapidly growing Asian pharma market with its constantly rising quality demands in terms of packaging and drug delivery. In the unanimous assessment of experts, China is already the fifth largest pharma market in the world.

In parallel with its local status as a technology advanced pharma glass plant the Danyang facility offers ideal conditions and flexible expansion possibilities to enable it to supply customers with high-quality specialist products in neighboring Asian countries and other market regions as well. "We work at the highest level of internationally recognized quality standards," Raster stresses. The technical production processes are for example monitored by in-line camera systems - a product control process which is by no means universal industry practice in China or elsewhere. The clean-room concept also reflects the latest development status.

In Danyang, which has for years been regarded as a highly attractive industrial location for foreign investors in particular, Gerresheimer Shuangfeng also has a second production plant exclusively for pharmaceutical vials. In addition, the company manufactures vials and ampoules in Zhenjiang, also in the Province of Jiangsu. Four other plants of the Gerresheimer Group also manufacture in the country. In total, Gerresheimer employs around 1,500 people in China.

Gerresheimer Opens New Primary Packaging Plant in China

German glass making giant Gerresheimer has opened a new packaging plant in Danyang, China, further indicating its plans to grow in the world’s fifth largest pharmaceutical market.

The new 16,000 sq.m. (172,160 sq. ft.) facility, which is situated 250km west of Shanghai at the heart of the region’s pharma manufacturing hub, will make vials and injection cartridges for local and international producers as part of the firm’s Shuangfeng subsidiary.

Standard & Poor’s (S&P) analyst Izabela Listowska told in-PharmaTechnologist that the facility “is an important strategic step not only to be well placed in this promising market but also to optimally serve global customers who favor producers with international presence.

“Gerresheimer is expanding its manufacturing footprint in China to be able to serve other very promising markets in the region,” continued Listowska, adding that S&P “view this expansion strategy as very positive for the credit quality of the company.”

Gerresheimer Shuangfeng currently runs three plants in China, including a second facility in Danyang that is exclusively for the manufacture of pharmaceutical vials, and has more than 150 production lines in operation.

In total Gerresheimer employs 1,500 people in China, and already has six manufacturing facilities producing glass vials, ampoules and syringes for a large number of domestic and international pharmaceutical firms.

Piramal Adds Trial Packaging and Distribution Capacity at UK Plant

Piramal Healthcare’s new clinical trial manufacturing, packaging and distribution centre in Northumberland, UK will help pharma industry customers to “build cost saving at an early stage,” according to European strategic manager Martin Hunt.

Hunt told in-PharmaTechnologist that the 13,000 sq. ft. primary and secondary trial packaging unit, which expands the active pharmaceutical ingredient (API), formulations and packing site in Morpeth, is part of an effort to offer a “one stop shop” for the drug industry.

He said that: “clinical trials are a very important revenue stream for Piramal,” and added that the expansion enables the firm to offer customers everything from API development to trial scale manufacture and ultimately commercial scale production.

Ian Morgan, head of Piramal’s clinical trial services (CTS), also told in-PharmaTechnologist about the potential benefits of the integrated formulations and clinical trial packaging offering.

He explained that the trial centre can conduct primary and secondary packaging for both solid and liquid products, which are then labeled according to trial protocols before being securely shipped to global trial sites worldwide via the dedicated distribution centre.

Piramal also launched a new website to both publicize its CTS offering and allow existing customers to monitor the status of their projects using the firm’s in-house “TrakPack” monitoring system.

Morgan said that: “This interactive website is vital in the evolution of our business and will help our customers better understand our offering.”

Piramal has been building its clinical offering for the last few years, most notably with the acquisition of Tangent Data, a Romanian contract research organization (CRO) specializing in the central nervous system (CNS) in 2008.

Commenting at the time of the Tangent deal, Piramal said that it is planning on expanding further over the next three years, setting up operations in Western and Eastern Europe, South Asia and North America.

IDT Biologika Establishes New Corporation in the United States

Ohly Opens Shanghai Application Centre, Sales Office at New Plant

Ohly is opening a new food application centre and sales office in Shanghai, as its new yeast extract plant in Harbin nears opening.

The company, part of ABF Ingredients, announced its plan to build the yeast extract facility in Acheng, Harbin, in late 2007. It is expected to be operational by the end of this year, and will produce more than 15,000 tons of yeast extracts for food and fermentation.

With the new food application and sales offices, Ohly says it is now closer to its Asian customers and better able to meet local customer demands and tastes. Although it has served the region before, Ohly has previously had no physical base in China.

The application centre – Ohly’s third worldwide – is briefed to develop and provide new savory ingredient solutions to meet changing market demands there.

In recent years Asian tastes have changed, as busier lifestyles and higher incomes have prompted demand for Western style convenience foods, including ready meals and snacks. Yeast extracts are used as taste enhancers for such savory products, and are increasing in popularity because of their natural origin.

The application centre will work in close collaboration with Ohly’s other, similar centers in Boyceville, Wisconsin, and Hamburg, Germany.

Rainer Huettermann, global sales director at Ohly, said: “It is an exciting time for all of us and we are confident that we can offer interesting solutions to the local food and fermentation industries”.

Ohly has three other yeast extract facilities around the world. It is not alone in identifying the growth opportunities for these extracts in food. Also in 2007 DSM announced a fast-track 35 per cent capacity expansion of its yeast extract production in The Netherlands.

Consultancy Leatherhead International puts yeast market growth at between 3 and 4 per cent per annum, and gives preferential use of yeast over other taste enhancers like monosodium glutamate and hydrolyzed vegetable protein as a driver.

Emerson Wins Singapore Bio Plant Contract

Industrial automation specialist Emerson Process Management has won the contract to help Swiss life sciences group Lonza design its new biopharmaceuticals plant in Singapore.

The firm claims that on average its approach to automation control improves the efficiency of manufacturing operations by 2 per cent in terms of throughput, availability and final product quality.

Emerson estimated that the new facility will cost around $350m (€246m) to construct and just over 12 months to complete.

EcoloCap to Make Important Acquisition

With this proposed acquisition, EcoloCap is taking a major step forward by broadening its initial goals in the environmental space. MBT, in partnership with Japanese and Korean partners, owns nanotechnologies that could play an important role in the energy and ecology sector.

MBT is a pre-commercial stage company dedicated to exploit nanotechnology applications initially in Carbon Nano Tube battery technology. Lab tests have produced data showing that MBT's CNT battery possesses far greater energy storage capacity, and demonstrated much shorter recharge time compared to anything that exists in the market today. In actual tests, the CNT battery has shown it can power an automobile for 400 miles on one charge, and be recharged in 10 minutes. Michael Siegel, MBT's president stated: "To overcome the limitations of present battery technology is the solution needed for electronics, electric vehicles and power storage commercialization. Our Carbon Nano Tube battery has 8 times the reserve capacity of existing lead acid batteries and can be recharged in less than ten minutes, for the same price or less".

Says Dr Tri Vu Truong, President and CEO or EcoloCap: "After a preliminary study of the technologies MBT is introducing, we believe that the Carbon Nano Tube battery has the potential to make a very serious impact on the advancement of the effort to get away from fossil fuel and reduce the Greenhouse Gas effect. Preliminary laboratory and pilot studies show that is can do this at a much favorable cost than existing technologies, with results many times superior. We will keep our shareholders informed of our findings as we progress in our due diligence."

At a time when the world is looking to alternative sources of energy, large scale application of this technology is actually an appropriate and effective step in the effort to get away from fossil fuel usage as well as reduce harmful gas emissions.

To maximize shareholder value EcoloCap is focused on projects which qualify for Carbon Emission Reduction credits (CERs) registered under the Clean Development Mechanism (CDM) of the United Nations' Kyoto Protocol. EcoloCap utilizes its know-how, capital, technology, engineering expertise, and on the ground operations management to work with governments and enterprises in emerging economies in order to successfully reduce greenhouse gases for both capture and utilization. By this process EcoloCap acquires UN Certified Carbon Credits (CERs) at favorable costs, which are then sold on the world market at prevailing prices.

University of Twente Spin-off Company Develops Spectacularly Fast Virus Detector

University of Twente May 28, 2009 Imagine being able to detect in just a few minutes whether someone is infected with a virus. This has now become a reality, thanks to a new ultra-sensitive detector that has been developed by Ostendum, a spin-off company of MESA+ Institute for Nanotechnology/University of Twente. The company has just completed the first prototype and expects to be able to introduce the first version of the detector onto the market in late 2010. Not only does the detector carry out measurements many times faster than do standard techniques, it is also portable, so it can be used anywhere. Ostendum's Aurel Ymeti (R&D director), Alma Dudia (Senior Researcher) and Paul Nederkoorn (CEO) claim that if they had the right antibodies to the swine flu at their disposal, they would be able to highlight the presence of the virus within five minutes. In addition to viruses, the device is also able to pick up bacteria, proteins and DNA molecules.

IBM & Bulgaria Cooperate in Bulgarian Nanotechnology Center

IBM and the Bulgarian government today officially announced their cooperation in the area of nanoscience and a deal for IBM to support the creation of what will be the first Bulgarian nanotechnology center.

The General Framework Agreement defines the scope of cooperation between IBM and the Bulgarian government and ways to encourage industry, universities and the Bulgarian Academy of Science to work together in the emerging field of nanoscience. The government's three-year program is aimed at creating different nanoproducts, micromachines and microsystems.

In a separate commercial agreement also being signed today, IBM technology and business consultants will assist the Bulgarian government in establishing a new nanotechnology research facility which will use state-of-the-art equipment to explore and develop new innovations in nanoscience. To enable the computing-intensive projects, the new laboratory will draw on IBM's Blue Gene -- the most powerful Bulgarian supercomputer, owned by Bulgarian State Agency for Information Technology and Communications

"Realising high-tech projects like this is key in the current environment when it is important to not only focus on short-term measures, but to also create the basis for future recovery," said Plamen Oresharski, Minister of Finance, Republic of Bulgaria. "We have a window of opportunity right now to transform industry to become more technology intense. This will not happen automatically, but requires dedicated effort, part of which is the current agreement with IBM."

"Today's agreement is a true step forward for Bulgaria and for its partnership with the United States," said Nancy McEldowney, US Ambassador to Bulgaria. "It positions Bulgaria as a leader in innovation, opening up many new possibilities and extending the horizon for both of our countries."

Once the center is created, its Bulgarian government intends to conduct applied research in the following areas:

* Microfluidics and nanofluidics - to gain a better understanding of cells and tissues and other biological specimens to support drug toxicity testing and the development of new medicines.

* Nanosystems for electronics and sensing - using nanoscale sensors and actuators to support the development of point-of-care diagnostics, environmental monitoring (such as atmospheric pollution analysis) and security.

* Nanomaterials - advanced virtual substrates for compound semiconductors which could pave the way for future, nanoscale electronic circuitry.

"Bulgaria's important step into the world of nanoscience creates a global opportunity for the country and the region," said Marcelo Lema, General Manager, IBM Central and Eastern Europe. "IBM has been a leader in nanoscale science for many years and our participation in this project will support the accelerated success of the Bulgarian Nanotechnology Center. We see this type of collaboration as an emerging model for future industry-academic partnerships."

Due to be completed next year, the Bulgarian Nanotechnology Center will occupy nearly 500 square meters of laboratory space and will support researchers and engineers working in close collaboration with Bulgarian universities.

"According to Lux Research, nanotechnology will impact $2.9 trillion worth of products across the value chain by 2014," said Alex Rakov, Country General Manager, IBM Bulgaria. "I am extremely proud that IBM will help Bulgaria to be at the forefront of this trend and further support its efforts to become a knowledge based economy."

Nanotechnology is the field of applied science focused on the reliable and repeatable design and control of the structure of very small objects. The length scales range from the atomic to the macroscopic -- generally, from one to 100 nanometers. A nanometer is one-billionth of a meter -- roughly 100,000 times thinner than a human hair. Nanotechnology is expected to spark advances in various fields. These include advanced functional materials, nanoelectronics, information and communication technology, sensing, tools, healthcare and life sciences, and energy technology. Nanotech applications in the energy sector for example which ensure more efficient use of solar energy, or new ways of purifying or desalinating water, may even help tackle some of the biggest challenges of our time.

China Opens Labs to Small Business

A top government academy in China has pledged to offer free laboratory services to small and medium-sized enterprises during the economic downturn.

The prestigious Chinese Academy of Sciences (CAS) said the move was aimed at helping businesses to enhance their innovation capacities amid the global financial crisis.

Under the new plans, more than 100 research institutes under the supervision of CAS will provide free and analysis and testing service for these companies, CAS said in a statement.

Nanotechnology and bioscience services were on offer to companies, as well as biodiversity, marine sciences and earth sciences.

New Zealand Grants $17M for Genomics Facility

A New Zealand consortium led by the University of Otago will receive NZ$26.5 million (US$16.5 million) from the government to develop a genomics research facility.

University of Otago Professor Anthony Reeve confirmed that the consortium, which includes the University of Aukland, Massey University, and AgResearch and other Crown Research Institutes, will receive the funds for a genomics facility.

In line with the original funding plan, which was announced in September, the Ministry of Research, Science and Technology plans for Otago University to administer the funding through a trading company called New Zealand Genomics Ltd. It plans to use the money to buy genetic sequencing tools, bioinformatics equipment, and to hire staff. That plan originally called for NZ$40 million to be given to the collaboration over nine years to conduct gene sequencing and analysis for customers from New Zealand and from abroad.

Reeve told GenomeWeb Daily News in an e-mail that the funding has not necessarily been cut by NZ$13.5 million, but that the money is "essentially the same," although for a shorter period.

Reeve expects that the university will probably use some of the funding to buy a third-generation sequencer.

PRA Opens Drug Safety Center in Brazil

PRA International has opened a Drug Safety Center in its São Paulo, Brazil office. Part of the company's safety and risk management unit, the center is responsible for serious adverse event and adverse drug reaction management. The drug safety center also supports clients with all other aspects of pharmacovigilance to help ensure regulatory compliance.

PRA currently operates two dedicated drug safety centers in Charlottesville, VA and Mannheim, Germany. The center in São Paulo adds to the company's presence in Latin America and provides additional global reporting capabilities. The safety and risk management team offers services throughout a product's life cycle. The company also provides services to support EU-RMP, FDA-REMS, annual safety reporting, IND reports and other services.

"The opening of the São Paulo Drug Safety Center enables us to expand our capabilities and level of service in Latin America and enhances our ability to provide standardized Drug Safety services globally, by growing and strengthening our overall safety team," noted Dr. Sabine Richter, PRA's vice president of safety and risk management. "This new center will allow us to create cost-effective and efficient global coverage that is enhanced with a local language and regulatory knowledge base. Both are key to our continued expansion of clinical trial and post-approval delivery in Latin America and globally."

Vietnam Invests in Raw Materials Capacity

Nguyen Tan Dung, Prime Minister of Vietnam, has approved plans to develop the country’s pharma raw material capacity by building six chemical plants and two laboratories, according to media reports.

VOVNews reports before 2015 $100m (€71.7m) will be invested in the chemical plants and $13m in the laboratories. This is expected to meet 20 per cent of domestic demand for raw materials by 2015, with this figure rising to 70 per cent by 2025.

The investment is intended to reduce Vietnam’s reliance on imports of intermediates involved in the production of treatments for cancer, HIV and drug addiction.

Furthermore, Vietnam hopes that the investment will encourage use of high technology to produce excipients, adjuvants, vaccines, and antibiotics and boost foreign investment.

Alcon Breaks Ground On Singapore Drug Plant

Eye care products maker Alcon Inc. said it broke ground on a drug manufacturing plant in Singapore, its first in Asia.

The Swiss company announced its plans to build the plant in April 2008. The company says it is experiencing rapid growth in Asia, and will make drugs for ailments including glaucoma, eye infectious, inflammation, and dry eyes at the plant. It expects to complete the 330,000 square foot facility in 2012. Alcon said the new plant will create 150 new jobs.

Drugmaker Novartis AG bought a 25 percent stake in Alcon from Nestle SA, and plans to take control of 77 percent of Alcon.

In afternoon trading, Alcon shares rose $1.74 to $103.42.

McIlvaine Company,

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061;

E-mail: editor@mcilvainecompany.com;

Web site: www.mcilvainecompany.com