With seed money from the National Science Foundation (NSF), bioengineers from the University of California, Berkeley, and Stanford University are ramping up efforts to characterize the thousands of control elements critical to the engineering of microbes so that eventually, researchers can mix and match these "DNA parts" in synthetic organisms to produce new drugs, fuels or chemicals.

Today, a single designer microbe can take years to create and cost tens of millions of dollars, since each control element a promoter or transcription factor has to be identified, characterized and tweaked in order to be reused. One UC Berkeley project to engineer microbes to produce the anti-malarial drug artemisinin took 10 years to get out of the lab into small-scale production, at a cost of $25 million.

The new effort, called the BIOFAB: International Open Facility Advancing Biotechnology (BIOFAB), aims to produce thousands of free, standardized DNA parts to shorten the development time and lower the cost of synthetic biology for academic or biotech laboratories. The BIOFAB has received two years of funding from the NSF and matching support from founding partners Lawrence Berkeley National Laboratory (LBNL) and the BioBricks Foundation (BBF), a non-profit organization that supports and promotes the use of synthetic biology.

"Synthetic biology has the potential to make the engineering of biology much easier and more affordable. Via the BIOFAB, we will help ensure that the public's investments and interests in the next generation of biotechnology return the greatest benefits," said founding BIOFAB director Drew Endy, an assistant professor in Stanford's Bioengineering Department and president of the BioBricks Foundation.

"This is an opportunity to build a framework that will allow us to set open standards for how we do biological design in the future, so that biological parts work reliably in everyone's hands," said BIOFAB co-director Adam Arkin, UC Berkeley professor of bioengineering and head of Synthetic Biology for LBNL's Physical Biosciences Division.

The BIOFAB takes its name from the fabrication, or Fab, that service laboratories established in the early semiconductor industry to make it easier for academic and small industrial labs to design and manufacture small quantities of custom chips. With computer-aided design (CAD) software, rapid-prototyping equipment and clean labs, Fab Labs could quickly produce innovative devices not yet ready for mass production.

"The professionally-staffed BIOFAB production facility will provide an essential resource that will allow many academic researchers and others to rapidly prototype, test and translate their foundational discoveries and ideas into practice," said Jay Keasling, UC Berkeley professor of chemical engineering and of bioengineering and senior faculty scientist and acting deputy director of LBNL. "By enabling everyone to better work together, the BIOFAB will make the engineering of biology easier and more predictable."

Keasling, who chairs the BIOFAB executive committee, led the project to biosynthesize artemisinin. He is now director in Emeryville, Calif., of the Department of Energy's Joint BioEnergy Institute (JBEI), which focuses on developing commercially viable biofuels.

Endy and Arkin proposed a similar Fab Lab for biology more than 10 years ago, but only now, Endy said, is the time ripe for an open and cooperative full-scale production facility.

"Besides Tom Knight (of the Massachusetts Institute of Technology), very few people were talking about standard biological parts 10 years ago," said Endy, while today, such parts are widely used by college students as part of the International Genetically Engineered Machine competition (iGEM), catalogued by institutions such as MIT and JBEI, and used daily in synthetic biology labs around the world.

Nevertheless, of the estimated 3,500 critical control elements in an E. coli bacterium, fewer than 100 have been seriously studied and characterized. Of the 500-plus promoters listed in current registries, for example, fewer than 50 have been measured, Endy said.

"What exists today is not a professional parts catalog," Arkin said. "But the parts we have, while not perfect, are better than nothing, and they are helping researchers all over the world."

"We now need to move beyond Lego metaphors and genetic toys to professional technologies," Endy added.

Operating in partnership with the UC Berkeley-led, NSF-supported Synthetic Biology Engineering Research Center (SynBERC) directed by Keasling, the BIOFAB is raising additional funds to hire 29 full-time staff who will systematically refine, standardize and characterize the activity of each genetic control element in E. coli, so that large-scale collections of genetic parts can be treated more like standardized components. What the researchers learn will be applied to parts collections in other microbes and used to assemble engineered biological systems.

"Even though we will be building parts and making systems, we are still in the foundational research stage," Arkin cautioned. "But in starting BIOFAB, we will accumulate the specialized know-how and the community of researchers necessary to become a resource for production and training in synthetic biology."

The BIOFAB also will promulgate standards for technical and professional practice through application of resources such as the BioBrick Public Agreement, a new legal framework supporting open technology platforms in genetic engineering.

"The BIOFAB promises not just to deliver needed foundational technologies, but do so in support of open innovation and collaboration in biotechnology," said David Grewal, a Harvard Fellow and BioBricks director.

To best accomplish its goals, the BIOFAB is also fully integrating ethics research within its production planning and operations.

"Our task is to generate resources and help make decisions regarding ethical issues, including safety, security and communities in genetic engineering, so that we can lead the development of open technology platforms in biotechnology that increase capacities and support human flourishing," noted Gaymon Bennett, doctor of theology and head of BIOFAB Human Practices.

Miami Dade College Opens Science Complex

“This will be a magnificent factory producing great minds,'' said Eduardo J. Padrón, president of Miami Dade College, addressing school officials, students and community leaders at a ceremony to officially welcome the new facility.

With 21 laboratories, a greenhouse, a rooftop observatory deck and botanical garden, MDC officials are hoping the $37 million facility gives its students an edge when it comes to applying for research internships, graduate programs, and science- and technology-based jobs.

The sprawling blue building and its pristine classrooms are a big upgrade from the previous building dating back to the 1960s.

Construction on the science complex started in May 2006, and was funded primarily through state and federal grants. School officials are hoping the complex, at 11380 NW 27th Ave., can eventually serve as a research center for renewable energy sources and technology, in addition to training students for careers in environmental sciences and biotechnology.

``This will position South Florida to compete in the high-wage, high-skilled, science economy,'' Padrón said at the ribbon-cutting ceremony.

Some of the students have already started conducting a variety of research, such as looking at the genetic make-up of a fava bean and tracking the growth patterns of a bacteria linked to stomach cancer.

In turn, many of their projects have opened the doors to admission into Ivy League universities and competitive research internships.

LEO Pharma Officially Launches in the United States

Denmark-based LEO Pharma, a global leader in dermatology and critical care, today announced its official launch in the U.S. Headquartered in Parsippany, New Jersey, LEO Pharma U.S. will be one of the largest individual operations in the pharmaceutical company's network of worldwide affiliates and is expected to contribute significantly to the company revenues in 2010. The U.S. operation will initially market the company's psoriasis franchise.

LEO Pharma recently reacquired U.S. marketing rights for its psoriasis treatments - TACLONEX(R), TACLONEX Scalp(R) Topical Suspension, DOVONEX(R) Cream and DOVONEX(R) Scalp Solution from Warner Chilcott for $1 billion dollars. The company has employed a contract sales force and will begin marketing and selling these products in the U.S. effective Jan. 19, 2010.

"The launch of our new U.S. affiliate is part of LEO Pharma's commitment to growth and strengthens the company's long-term global vision of providing competitive drugs to patients and society. LEO wants continuously to provide improved treatment options and support the research and development of novel therapies to patients with skin diseases and disorders," said Gitte Aabo, CEO and President of LEO Pharma. "The U.S. operation will be a cornerstone of our business, with plans to further expand into other top global markets."

LEO Pharma has a robust pipeline including several products in late-stage clinical studies for psoriasis, eczema and - through a recent acquisition of Peplin Inc. - actinic (solar) keratosis, a common pre-cancerous skin lesion.

"LEO Pharma's treatments for skin disorders are already the market leaders in the United States, and our current portfolio combined with one of the strongest pipelines in dermatology has positioned LEO to become the leading pharmaceutical company in the American dermatology market and worldwide," said John Koconis, President and Chief Executive of LEO Pharma U.S. John Koconis is relocating from the United Kingdom where he previously led Leo Pharma's Dermatology Division and has been with LEO Pharma for over 10 years.

Federal Funds to Support Infrastructure at New Penn State PGx Center

The Penn State Hershey Cancer Institute at Penn State Milton S. Hershey Medical Center will open its new Center for Pharmacogenetics later this year, using $3.2 million in federal funds recently appropriated for the facility, the institute's director said.

"The money will pay for infrastructure support in terms of data managers and research nurses that will help us accrue patients to the studies," as well as "perhaps maybe some statistical help," said Tom Loughran, director of the cancer institute.

Hiring is projected to take place in the spring or summer. The number of employees, and their specialties, will be better known as the center finalizes its research specialties and can project patient volumes. "Probably we'll start out by hiring maybe five or six people," Loughran said in an interview.

He also said the pharmacogenetics center is expected to attract "ballpark, to start with, 20 or so" scientists — from physicians based at the medical center campus in Hershey, Pa., where the cancer institute is located, to researchers based either there or at Penn State's main campus about 100 miles northwest in University Park, Pa.

The researchers will include bioinformatics professionals, biochemists, biostatisticians, geneticists, genomics researchers, molecular biologists, and pharmacologists. The extent of scientist and physician interest in the pharmacogenetics center will be better known following a workshop to take place.

"We really aren't going to be adding any new investigators" for the pharmacogenetics center, Loughran said, even as the cancer institute continues to recruit researchers for its own work.

While many additional details remain to be worked out, he added, the cancer institute anticipates receiving funding for the pharmacogenetics center "in the next few months."

"It will start this year. We anticipate starting in the next three months," Loughran said.

He spoke four days after joining administrators of the medical center and US Rep. Tim Holden (D-Schuylkill County) in announcing the federal funding for the center. Holden, who is up for re-election this year and faces a possible primary as well as a likely Republican challenge, included the money as an earmark within the US Department of Defense Appropriation for the 2010 fiscal year, which was announced last week.

However, the $3.2 million is less than half of the $7.5 million originally requested by Holden.

As a result, the center is developing plans to start operations by focusing on selected forms of cancer — breast cancer, lung cancer and leukemia — rather than immediately study all forms of the disease. Over time, however, the cancer institute has flexibility to shift the center's funding and staff to study different diseases should research suggest such a need, Loughran said.

"The major impact is we need to be more focused in our efforts," he said.

Holden previously secured through earmarks more than $30 million for the cancer institute, toward equipping its $153 million, 185,000-square-foot facility, which opened last July 13.

Philip Lazarus, the cancer institute's associate director, will serve as director of the pharmacogenetics center. Lazarus also serves as the institute's program leader for cancer control and population sciences, as well as a professor of pharmacology and public health sciences at Penn State Hershey College of Medicine.

Loughran said the center will build upon Lazarus' research, which has focused on how inherited genes interact with the environment to either trigger or lead to increased risk of cancer, as well as how different individuals respond to therapeutics, leading to varied outcomes.

The center will house the cancer institute's samples, and serve as a resource and research center for translational studies focused on oncology drugs and prevention approaches. Specimens from the repository will be used to study individual responses to therapeutic drugs and environmental toxins, in efforts to identify gene variations that could serve as markers for these traits, and could then be used to develop or tailor treatments to individuals.

Penn State Hershey will carry out pharmacogenetics research for the US Department of Defense National Functional Genomics Center, a network of partnerships among the DoD, universities, and companies established in 2002 to stimulate translational research intended to help diagnose and treat cancer.

After speaking to counterparts within NFGC, Loughran said, he anticipates the cancer institute will spend its appropriation over three years, as has been the case when other consortium members received federal funds directed toward research.

Roughly $2 million of the $3.2 million will be used toward direct costs, the remainder for indirect costs — about the same proportion as with a regular research grant, he said.

"We hope to be able to continue funding down the road," Loughran added.

Capsugel Expanding South Carolina Plant

A company that makes capsules for medicine and other ways to deliver liquid drugs is expanding its South Carolina plant and adding 50 jobs.

Capsugel will expand its office, lab and production space to make more room for a liquid-filled capsule made at its Greenwood County plant.

Company officials say work on the project began last month and should be finished in about a year.

Nelson Labs Expand In Utah

Taylorsville-based Nelson Laboratories Inc. will conduct an open house to announce the creation of 75 to 100 new jobs as the company expands its operations into a new $13 million, 50,000-square-foot building adjacent to its other facility located at 6280 S. Redwood Road.

The company is a contract laboratory with clients in the medical device, pharmaceutical/biopharmaceutical, dietary supplement and tissue industries. It opened in 1985 in Research Park near the University of Utah with five employees and 40 tests and now offers more than 400 microbiological and analytical tests.

The company moved to Taylorsville in 1994, when it opened a 62,000-square-foot facility that maintains 80 labs and a 3,000-square-foot cleanroom. The company serves more than 4,000 clients in 56 countries from that site, which has more than 320 scientists and staff.

"We're helping … to make sure products are safe, sterile and functional," president and chief executive officer Jeff Nelson said.

The new building increases the number of labs and nearly doubles the amount of administrative space for the medical testing company, he added.

Florida Biologix Expands Bioreactor and Fill Capacity

A recently completed manufacturing and filling capacity expansion will help Florida Biologix meet deadlines and win repeat business according to company director Richard Snyder.

The Alachua contract manufacturing organization (CMO), which makes biopharmaceuticals for Phase I and II clinical trials, installed a 400L disposable bioreactor at its production plant and a 10L culture vessel at its process development laboratory.

The firm has also increased its Class aseptic filling capacity by 70 per cent, enabling its Class 1000 fill suite to fill batches of 5,000 vials for containers in the 0.1ml to 3L size range.

In a press statement, Synder said the investment “underscores [Florida Biologix’] commitment to continue to meet the needs of our clients who appreciate how we are able to find cost-effective solutions for their clinical projects, overcome difficult technical challenges and deliver released products on-time”.

He added that: “We believe that the best way to build long-term relationships with our clients is through frequent, open communication, delivering on-time and providing clients full ownership of their manufacturing process.“

Spokesperson Chris Aytug told Outsourcing-pharma that demand for larger capacity had been a key motivation for the expansion, explaining that the firm’s deal with America Stem Cell had “played a role in the decision, but was not the only factor. They will be utilizing the capacity along with others.”

Aytug went on to speak about recovering demand for this type of contract manufacturing work in the clinical trials sector, after the industry-wide drop that has accompanied the economic downturn over the last 18 months.

"Inquiries and contracts dipped in late 2008 and the first half of 2009, but then picked up dramatically for us in the second half of the year. Activity this year seems to be picking up again, but time will tell."

Lonza to Close Its API Plant in Riverside, Pennsylvania

Lonza will shut down its API plant in Riverside, Pennsylvania, US by the end of the year as part of a plan to cut costs and shift small-molecule production to Asia.

Operations at Riverside, as well as those at a vitamin K3 production facility in Shawinigan, Canada and a sales office in Wokingham in the UK, will cease by Q4 2010 under the Swiss firm’s “Project Bond ” cost cutting program.

Lonza said it is “in contact with all Riverside customers to offer tailored solutions that will strengthen the supply security of their individual drug substances by transferring the projects into other operations within Lonza’s global network.”

And, although the firm did not provide additional information, it is likely that active pharmaceutical ingredient (API) production carried out in Riverside, as well as vitamin K3 manufacture, will be transferred to its plant in Nansha, China which has the capacity for both.

Operations in Wokingham will be transferred to a facility in Verviers, Belgium which already manages a significant proportion of Lonza's European supply chain.

CEO Stefan Borgas said the closures, which will affect 175 employees and cost CHF140m (€94.5m), will increase the firm’s competitiveness and are “a key element in our endeavor to bring Lonza back to a sustainable growth".

Cel-Sci Validates Manufacturing Facility

Cel-Sci has completed validation of critical utilities and production equipment at its GMP facility which uses cold 4ºC aseptic filling to improve the shelf-life and potency and biologics.

The plant in Baltimore, Maryland, US is now ready for Cel-Sci to begin manufacture of its cancer drug Multikine (Leukocyte interleukin injection) in preparation for a head and neck Phase III clinical trial.

Also, Cel-Sci is now ready to offer contract manufacturing services from the facility and these could begin once it has produced the material required for the Phase III trial.

This could provide an additional revenue stream as Cel-Sci awaits Multikine’s regulatory approval and attempts to recoup some of the $22m (€15m) it cost to build the facility.

Abilene Life Sciences Accelerator Now Research-Ready

The new Abilene Life Sciences Accelerator is now a research-ready laboratory space.

Receptor Logic, Abilene’s only biotechnology company, moved in from its rented space at Texas Tech University’s School of Pharmacy.

Only part of the roughly 20,000-square-foot ALSA building, a more than $10 million project located at Pine and North 13th streets, is open, with construction expected to continue through March.

Money for the ALSA project came from the Development Corp. of Abilene, which uses the city’s half-cent sales tax to fund economic development projects. The DCOA hopes the investment, begun in 2007, will pay off with a cluster of science companies that bring high-paying jobs to Abilene.

Abilene isn’t alone, however, with other mid-sized Texas cities like Georgetown and Temple also striving to built their bioscience industries.

Receptor Logic is renting 3,188 square feet at $25 per square foot, said Richard Burdine, chief executive officer of the Development Corp. of Abilene.

The lease cost was negotiated when Receptor Logic moved from Amarillo to Abilene in 2007, said Burdine, though he noted that the company — whose focus includes cancer-related research — did not receive a cash incentive for moving to Abilene.

The DCOA did purchase equipment for the company to use.

While researchers were busy unpacking lab equipment, construction crews continued to finish other lab space inside the building.

“We’ll have 10 additional labs to lease, ranging from the smallest at 568 square feet, and the largest, at 1,262 square feet,” with suite-style doors that allow for expansion, Burdine said.

For now, however, Receptor Logic, managed by Austin-based Emergent Technologies, is the only tenant, Burdine said.

Late last year, the DCOA signed a deal with Emergent Technologies, which began as a venture capital company, to manage the ALSA building and develop a strategy for recruiting more tenants.

Having a tenant in place is an important milestone, said ALSA Director David Sougstad, something that can be looked at favorably by prospective tenants.

“It’s one thing to say, ‘We’ve got this thing that’s coming together,” Sougstad said. “Then it’s another thing for them to actually see someone in there functioning and it working the way you expect it to.”

Johns Hopkins and Saudi Collaborate on Eye Research

The Wilmer Eye Institute of Johns Hopkins Medicine has announced that it will collaborate in research, education and patient care with the King Khaled Eye Specialist Hospital in Riyadh, Saudi Arabia.

“We at the Wilmer Institute have been interested in the study and cure of blinding eye diseases around the world, and the King Khaled Eye Specialist Hospital is certainly one of the most impressive eye hospitals outside of the United States,” says Peter McDonnell, director of the Wilmer Institute. “Working in close collaboration with the excellent experts at the King Khaled Eye Specialist Hospital, and combining the expertise of our two institutions, will allow for more rapid evaluation of potential new therapies than would be possible with either hospital working alone”.

A major focus of the affiliation will be the training of the next generation of leaders in ophthalmology in both countries and beyond. These are the scientists who will be developing new procedures and new treatments for eye diseases that currently are not curable. Wilmer Institute already has trained more than one hundred chairpersons in departments of ophthalmology in dozens of countries.

“We are delighted to enter into this affiliation with the Wilmer Institute,” says Abdul Elah Al-Towerki, executive director of the King Khaled Eye Specialist Hospital. “We chose the Wilmer Institute because of its commitment to excellence and track record of advancing the field of ophthalmology. Both of our institutions have great strengths, and working closely together in this affiliation will allow us to accomplish more, in a shorter period of time, than we could working alone. This affiliation is supported at the highest levels within the government of Saudi Arabia”.

Several Wilmer faculty members will work at the hospital for extended periods-—treating patients, teaching and conducting research. With financial support from the Saudi Government, joint research activities will focus on developing treatments for blinding eye diseases, such as diabetic eye disease, that afflict patients living in both countries and around the world. In addition, a new endowed professorship at Johns Hopkins will be established to support the work of Hopkins’ faculty.

The Wilmer Institute is one of the largest medical institutes devoted to treatment and cure of eye diseases in the U.S., with more than 130 full-time faculty members, and is recognized as one of the premier research, training and patient-care facilities in the world.

The King Khaled Eye Specialist Hospital is the largest eye hospital in Saudi Arabia, and is one of the top-ranked medical facilities in the Middle East.

Edward Miller, dean of the medical faculty and CEO of Johns Hopkins Medicine, points out that one of Johns Hopkins Medicine’s chief missions is to work with organizations around the world to advance medicine. “We’re pleased by this affiliation and expect it will lead to successful collaborations in teaching, research and improving the care of patients with eye diseases”.

API Production Starts at Evonik's New Plant

Production has begun at the U.S. API plant German chemicals firm Evonik Industries recently bought from drugmaker Eli Lilly.

The Tippercanoe Laboratories unit in Lafayette, Indiana will manufacture a range of active pharmaceutical ingredients (API) for pharma firms, beginning with Lilly, on a contractual basis as part of an expansion of Evonik’s healthcare arm.

Evonik said that the facility, which employs a workforce of 650 people, significantly strengthens its “exclusive synthesis business in the US and offers scope for further long-term growth.”

The 2,400 acre site was sold by which was sold by Lilly late last year as part of the drug major’s strategy to reduce internal manufacturing capacity and buy in more APIs and drug intermediates.

MPI and Bioject Form Alliance

US preclinical CRO MPI Research has formed an alliance with Oregon-based needle-free delivery specialist Bioject Medical Technologies.

The alliance will focus on the early-stage development of injectable therapeutics and provides Bioject with “preferred partner” access to MPI’ range of testing capabilities.

The Michigan-based preclinical contract research organization (CRO) services include preclinical safety and toxicology analysis which will be applied to Biojects in-progress and future development programs.

Perhaps more importantly, the partnership deal also offers MPI Research the opportunity to provide Bioject’s needle-free injection therapy systems (NFITS) technology as an alternate delivery option to client drug manufacturers it works with.

This part of the accord is significant because demand for needle-free delivery systems is expected to increase dramatically over the next few years, particularly as the biologic drug market continues to grow.

Kalorama Information was one of the observers to predict such an expansion, forecasting in a September report that the needle-free technology market will grow to be worth $2.7bn in the medium term.

Bioject and MPI were also positive that the alliance will generate other growth opportunities, highlighting the global vaccines market as an example.

The firm’s predicted that their alliance “increases the possibility that [they will be able] to secure government sponsored grants or funding directed at improvements in drug and device or vaccine and device based treatments.”

Bioject CEO Ralph Makar said the deal “Allows each partner to leverage the strengths, resources and technologies available that we believe will lead to additional new business opportunities for both companies.”

MPI Research CEO Bill Parfet, agreed, suggesting the firms “share an innovative and entrepreneurial spirit that creates a synergy vital to our industry.”

Luitpold Buys PharmaForce for Generic Injectables

Daiichi-Sankyo subsidiary Luitpold Pharmaceuticals has acquired PharmaForce, Ohio, giving it a 40,000 sq. ft. cGMP compliant sterile manufacturing facility and a 20,000 sq. ft. API production plant.

The deal is part of Luitpold’s efforts to diversify its product portfolio and generate growth. In particular Luitpold has identified the generic injectable market as a growth opportunity.

By acquiring PharmaForce it has strengthened its position in the market for difficult to manufacture sterile drugs and generic injectables and bolstered R&D and production capacity.

In addition to the current good manufacturing practice (cGMP) compliant facility and the active pharmaceutical ingredient (API) production plant the deal also includes a 20,000 sq. ft. R&D site.

Acquiring the R&D site immediately boosts Luitpold’s infrastructure, expertise and pipeline, providing it with a platform to become the sole source or first-to-market for generic injectable products.

The acquisition has been cleared by the US Federal Trade Commission (FTC) and Luitpold has purchased 100 per cent of PharmaForce’s stock. Following the deal Columbus, Ohio, US-based PharmaForce’s products will be marketed by Luitpold’s subsidiary, American Reagent.

Daiichi targets Africa

Daiichi-Sankyo, which owns Luitpold, is planning to use Ranbaxy Laboratories’, also owned by the Japan-based pharma, presence in Africa to launch a product in six countries on the continent.

In December 2009 Daiichi outlined its intention for Ranbaxy to launch Olmesartan Medoxomil, originally discovered by the Japanese pharma, in Kenya, Mozambique, Nigeria, Tanzania, Uganda and Zambia.

This will use Ranbaxy’s established presence in Africa and is a continuation of Daiichi’s efforts to benefit from the companies’ respective strengths following its $4.5bn (€3.1bn) acquisition of the Indian generics firm.

Companies Battling for Edge in the Biopharmaceutical Industry

Companies battling for an edge in the biopharmaceutical industry have $2.3 billion in manufacturing plants in development in the Boston area to produce genetically engineered drugs.

For the first time since the early 1990s, new factories — not just expansions of existing ones — are going up in this area, according to the Massachusetts Biotechnology Council. In the early ’90s, about 20 biopharmaceutical companies with about 2,500 workers built manufacturing plants in the state, according to the council.

With development costing about $2,400 a square foot for special materials, equipment and equipment testing, decisions to build in Massachusetts, where the cost of living is high, are not made lightly. But biotech companies come here to mine the region’s research and production talent.

Those already here tend to stay to keep together the teams of scientists, doctors and engineers who create manufacturing processes to grow living cells that produce therapeutic drugs. By contrast, traditional drugs are often made by combining chemicals that react to one another.

Many biotech businesses want to be in Cambridge or Boston, close to mentors, colleagues, friends and competitors in the research communities around the Massachusetts Institute of Technology and Harvard. But in the last few years, several companies have developed space in nearby, less-expensive suburbs.

The companies can build a campus with separate buildings for offices, labs, storage and the factories that must be nearly as clean as a surgical suite to avoid product contamination. If a factory occupies its own building, it is easier to control the environment and avoid costly production slowdowns that can batter a company’s image and stock price. Some suburbs approve new projects in months rather than the years Boston may require.

Seeking a balance between suburban convenience and proximity to Boston and Cambridge, the New York-based Bristol-Myers Squibb Company chose a site about 40 miles west of Cambridge for its largest development: a $750 million, 300,000-square-foot manufacturing and office complex with about 260 workers, a company spokeswoman said.

Construction has just been completed on the self-financed project, which has six buildings. In 2007 the company acquired the 89-acre site at Fort Devens, a former military base that the state converted into an office and industrial park. The company expects to have the factory in commercial production in 2011, said Christopher R. Perley, general manager of the complex.

“Massachusetts is supporting life science in places like Devens where it installed the utilities, wastewater treatment and roads we need,” Mr. Perley said.

This complex gives Bristol-Myers Squibb a chance to become a significant player in biopharma, said John Boris, managing director for investment research at Citigroup.

Bristol-Myers Squibb can now commercially produce the first major biologic drug that the company developed itself, Orencia, for rheumatoid arthritis, rather than contract out production.

“Its future growth depends on positioning itself for the biopharma explosion,” said Mr. Boris. Compared with chemically based pharmaceuticals, biologics are in demand because they can slow and even halt the progression of diseases. “They are life-saving, targeted medicines,” Mr. Boris said. But prices can be 10 times higher, reflecting the cost and expertise needed to produce them, he said. By 2015, he estimated, biologics could generate $3 billion, about 20 percent of annual company revenue, with half coming just from Orencia.

The architect for the new plant is Fluor Enterprises, a unit of the Fluor Corporation of Irving, Tex. Howard Boman, a senior vice president, said that creating a biopharmaceutical plant was very different from other jobs.

“It’s like designing a fine chemical plant with a hospital on top,” said Mr. Boman, in reference to the sanitary conditions required.

Outside, the plant seems to be a red panel and glass suburban office. Inside, it is dominated by two steel 30-ton water tanks and six 25,000-liter stainless-steel bioreactors. These are so large, they hang between floors, and the ceilings are nearly 30-feet high, said Michael A. Benedetto, the project executive for Skanska USA Building, the contractor.

“These facilities have a top-down layout because gravity helps move liquids through the system,” he said. To create an uncontaminated environment, walls and floors are made of easy-to-clean materials like epoxy, urethane and tile that can cost $15 a square foot compared with the concrete floor of a typical factory, which costs 25 cents a square foot. During construction, cleanliness was paramount. Pipes and ducts were sealed during fabrication, transport and construction to keep out dust and dirt. The building was sealed and special walkways set up for the crew “to limit boot and mud traffic,” Mr. Benedetto said.

Given the cost of building, companies want their facilities to be in operation quickly. To speed up the process, sections of the factory were built elsewhere, brought to an assembly plant nearby, then transported to Devens. During six months, 78 truckloads carried modules of tanks, pipes, instruments, platforms and stairs on trips that often required special permits, police escorts and road closings because of load size, he said.

In suburban Framingham, the Genzyme Corporation has just built a $300 million manufacturing complex and $150 million warehouse facility nearby, said Henry Fitzgerald, vice president of facilities operations for the Cambridge-based biotech company. Last month, Genzyme completed construction on a self-financed $168 million, 70,000-square-foot factory in the Framingham Technology Park that is expected to start commercial production in 2011. Genzyme already occupies one million square feet in 18 buildings there, 15 of which it owns, he said.

Framingham approved the new plant in 60 days and invested $12.9 million in water and sewer upgrades.

“It’s striking that $13 million helped us make a $300 million investment, but we can’t grow without infrastructure,” Mr. Fitzgerald said.

A competitor, Shire Human Genetic Therapies, a unit of Shire, based in England, recently uprooted from Cambridge to build a $394 million, 545,000-square-foot production complex in Lexington, where construction will be completed early this year. In Cambridge, its staff was in different buildings spread over several blocks. “In Lexington, it had its pick of spaces,” said Mr. Boris of Citi.

Meanwhile, Organogenesis, a company in Canton, Mass., is designing a 54,000-square-foot production plant across the street from its current site, said Geoff MacKay, the chief executive.

“We make living cells that replace tissue injured by accident, disease or aging,” he said. “A wound center can call us at 5 p.m. and we guarantee that by 8 a.m. the next morning we ship a live product with a 15-day shelf life.

“This is one of those rare instances when it doesn’t make sense to manufacture offshore,” he said. He added: “We have 50 Ph.D. scientists, medical doctors and engineers who work every day shoulder to shoulder with our manufacturing people.” He said that “we’re an M.I.T. spinoff plugged into the academic and scientific community. We didn’t want to lose those ties or our employees.”

Source: New York Times

Kaleida Health Gets Funds for Construction of Global Heart and Vascular Institute

Kaleida Health of Buffalo, N.Y., closed on a $100 million U.S. Department of Housing and Urban Development insured mortgage loan to fund construction of a new global heart and vascular institute.

The $100,253,000 loan is Kaleida's fourth HUD mortgage loan.

"With the challenges everyone is facing with the credit markets and a difficult economy, this is a tremendous accomplishment," said Joseph Kessler, executive vice president and chief financial officer of Kaleida Health. "The HUD loan will have a tremendous impact on western New York. The new global heart and vascular institute is destined to be the flagship hospital here with improved quality and better access for the patients that we serve."

Kessler said the $291 million facility would bring together Kaleida Health physicians and University at Buffalo researchers to deliver state-of-the-art clinical care, produce breakthroughs on the causes and treatment of vascular disease and spin off new biotechnology businesses and jobs.

The building will house four floors of Kaleida Health's $173 million merger of its cardiac, stroke and vascular operations, plus a new and expanded emergency department. It will also house research and development facilities, including four floors for the University of Buffalo's $118 million Clinical and Translational Research Center and a biosciences incubator.

According to Kessler, the complex arrangement brings together a not-for-profit as well as two government agencies, HUD and the State University of New York. He said overall savings are estimated to be between $18 million and $20 million by combining the organizations.

"This is a dynamic, long-term partnership and there are hopes to generate similar savings in the future as we discuss the possibilities of working together on other projects," Kessler said.

When complete, the Kaleida Health-UB facility (including Buffalo General's main bed tower) will house nearly 600 patient beds, 30 operating rooms, 17 interventional labs for cardiac, vascular and neurosurgical procedures, four CT scanners and four MRIs.

Kaleida anticipates that the new emergency department will accommodate more than 60,000 visits a year, while the hospital will discharge nearly 27,000 patients.

Construction, which began Sept. 1, 2009, is expected to take approximately two years to complete, with doors opening in late 2011.

Nuclea Diagnostic Laboratories Received Accreditation

Nuclea Diagnostic Laboratories has received accreditation from the College of American Pathologists for its diagnostic lab operations at Clark University in Worcester, Mass. The firm carries out molecular pathology testing services at the lab.

The Interdisciplinary Center for Biotechnology Research at the University of Florida Uses Data Management

The Interdisciplinary Center for Biotechnology Research at the University of Florida will use GenomeQuest's platform for sequence data management in next-generation sequencing-based services.

Deltagen Has Acquired Benten BioServices,

Deltagen announced that it has acquired Benten BioServices, a Pennsylvania-based contract services organization that conducts biosafety testing, raw materials testing, assay and process validation services, cell banking and characterization services, and technology platform-specific R&D support and consulting services. Deltagen issued 9,126,085 shares of its common stock, which closed at $.07 per share yesterday, to the former Benten shareholders. In addition, it said that Penn Venture Partners and Life Sciences Greenhouse of Central Pennsylvania invested $1,250,000 and $250,000, respectively, in the newly combined company.

Roche Diagnostics Opens a West Coast Training Center

Roche Diagnostics said that it has opened a West Coast training center in Pleasanton, Calif. The new center is housed at a facility owned by Roche Molecular Systems, and will provide customers with training on the firms molecular diagnostics and clinical chemistry/immunochemistry instruments. The firm said it plans to open a similar facility on the in New Jersey next year.

PepsiCo Opens Nutrition Driven Research Lab

PepsiCo is opening a new research laboratory in New Haven to help “fundamentally improve” the nutritional portfolio of its products.

Located next to the Yale University campus, the new laboratory will focus on long-term projects in the field of nutrition. The lab will be PepsiCo’s ninth global regional research centre, joining others in the US, Europe and Asia.

In addition to the lab, the company plans to fund a graduate fellowship in the MD-PhD program at Yale School of Medicine to support nutritional research in areas such as metabolic syndrome, diabetes and obesity.

Taken together, PepsiCo intends for the two projects to help provide the scientific support for a nutritional overhaul of its product range.

“Ultimately, we’re trying to make it easier for consumers to lead healthier lifestyles,” said Dr. Mehmood Khan, PepsiCo chief scientific officer.

Achieving this does not simply mean reducing fat, sugar, and salt levels, and then fortifying products with health ingredients like vitamins and mineral.

Manufacturers are very wary of compromising on taste or making any radical changes to their products for fear of putting people off their brands. Improving the nutritional profile of products is therefore a research heavy endeavor that takes time to complete.

Over the past three years, PepsiCo has increased its research and development spending by 40 per cent. A lot of that extra money has been channeled into giving its core soda and snack products a healthy makeover.

In Europe, for example, PepsiCo has introduced Baked Lay’s and Baked Walkers with 70 per cent less total fat than regular crisps.

Another strategy has been to spread out beyond the soda and snack core of the business in search of healthy growth. Investing in the Tropicana juice brand, and creating new varieties with new flavors and functional ingredients, is one example of this at PepsiCo.

454 Life Sciences to Expand Facilities

Roche's 454 Life Sciences is expanding into a new manufacturing space near its headquarters in Branford, Conn., the company confirmed.

The sequencing technologies subsidiary of Roche will spend $5 million on the 55,400-square-feet building, according to a report in The Hartford Courant. According to the paper, Roche will outfit the building for R&D efforts.

A 454 spokesperson confirmed the plans to build new manufacturing space, but she declined to provide any further details.

PharmaSphere Site Approved for Building

The Planning Board has paved the way for PharmaSphere LLC to break ground as the first tenant in the South Worcester Industrial Park.

The five-member board unanimously approved the definitive site plan for redevelopment of a 75,000-square-foot, vacant brownfield parcel at 49 Canterbury St.

On the site, which is also bounded by Gardner and Southgate streets, PharmaSphere intends to build a 50,000-square-foot bio-processing facility.

Not only is PharmaSphere going to be the first business to redevelop land in the industrial park, it is also the first company to go through the city’s expedited permitting process.

PharmaSphere, which has developed a new way to grow plants for use in cosmetics and health projects through the use of carousels and spheres, will cultivate medicinal plants at its facility. Purified extracts of compounds from the plants will be offered for sale as active pharmaceutical ingredients to pharmaceutical and biotechnology companies worldwide.

Under its agreement with the city, PharmaSphere will buy the parcel at 49 Canterbury St. for $1 and pay to prepare the site for construction.

Earlier this year, the $16.9 million project received a key financing component when the City Council granted a $2.5 million, eight-year loan to PharmaSphere.

The loan will come through the U.S. Department of Housing and Urban Development Section 108 loan program administered by the city.

Other financing components include $6.5 million of equity from Quarry Hill Partners, $4.9 million from the sale of federal tax credits under the New Markets Tax Credits Program, a $3 million, eight-year, Massachusetts Development Financing Agency bond and the Section 108 loan.

City officials have said that 58 full-time jobs will be created through the project, 51 percent of which will go to city residents.

Symmetry Closing Maine Manufacturing Plant

Medical implant maker Symmetry Medical Inc. said it will close a manufacturing plant in Maine as part of broader cost-saving efforts.

The company said the closing will cost between $2.4 and $2.8 million. Symmetry plans to transfer equipment from the plant to its other facilities.

A restructuring charge between $1.8 million and $2.2 million is expected in the fourth quarter, mainly consisting of employee severance costs and impairment of property and equipment.

Excluding the one-time charges, the company set its full-year 2009 guidance in the range of 63 to 68 cents.

Signature Genomic Labs Granted ISO Certification

Signature Genomic Laboratories has received certification from the International Standards Organization for its clinical lab services and products.

The ISO 9001:2008 certification specifically applies to the lab services and design and production of the Genoglyphix research-use-only products, including software, microarrays, and labeled DNA probes.

The Spokane, Wash.-based company performs diagnostic genetic testing of chromosome abnormalities in patients with unexplained mental retardation and birth defects.

"With this certification, our customers can be confident that Signature Genomics has an internationally recognized quality management system that is focused on meeting or exceeding their needs in a timely manner and continually improving all facets of our business," Richard Lloyd, quality manager of Signature Genomic Laboratories, said in a statement.

New California Collaborative Research Facility Breaks Ground

A consortium of three research institutes and a university, all based in the San Diego region, has quietly broken ground on a $126 million research facility intended to advance collaborations — a project delayed more than a year by California's budget squeeze.

The Sanford Consortium for Regenerative Medicine says the new "collaboratory" will pursue joint projects by its members and collaboration partners to invent tools and technologies intended to advance research into stem cells, and to discover and develop diagnostics and therapies.

The consortium's basic research focuses on stem cell growth and differentiation, neuroscience, cardiovascular biology, blood cell development, and vision science. Members of the consortium, formed in 2006 to build and operate the facility, are the University of California, San Diego, the Burnham Institute for Medical Research, the Salk Institute for Biological Studies, and The Scripps Research Institute.

Construction of the collaboratory officially began last week, Debra Kain, a spokeswoman for UCSD.

"The most important aspect of this consortium is for top researchers to work side-by-side in a common facility to create the breakthroughs needed to treat ALS, Alzheimer's disease, cardiac tissue damaged during heart attacks, cancer, and other medical problems," Kain said.

Almost half the collaboratory's cost — $62 million — will be paid for through tax-exempt bonds to be backed by credit support from the University of California, which owns the project's 7.5 acre site in La Jolla, Calif., on North Torrey Pines Road. California's budget problems over the past year delayed the UC guarantee for the project, explaining why it was originally to be completed in the coming year, but will instead open in 2011.

Another $43 million was approved last year by the California Institute for Regenerative Medicine, the state's stem-cell research agency, while $21 million will come from the $30 million gift announced last year by Sioux Falls, SD, philanthropist T. Denny Sanford.

Sanford's remaining $9 million will go toward preconstruction costs plus operation of the 145,087-square-foot facility. In return for accepting the $30 million gift, the San Diego Consortium for Regenerative Medicine agreed to rename itself.

The collaboratory's laboratory and office space is designed to accommodate about 336 investigators, and includes core facilities to accommodate sophisticated imaging technologies, as well as conference facilities including a 4,000-square-foot auditorium.

A formal groundbreaking ceremony is set for early in the spring, Kain said.

Thermo Fisher to Hire 116 at Ohio Facility

Thermo Fisher is planning to upgrade and add more than 100 jobs to a facility in Marietta, Ohio, a company spokesperson said.

The firm made the decision to upgrade the facility after it was announced yesterday that it would receive a seven-year, 50 percent job-creation tax credit from the state of Ohio.

Thermo Fisher will be adding production capacity and general upgrades to the approximately 420,000-square-foot Marietta facility, which manufactures cold storage equipment for laboratories, the spokesperson said.

In addition, the company plans to create 116 full-time equivalent employees in connection with the facility upgrade.

Thermo Fisher is one of 15 companies that will receive tax credits from Ohio to create new jobs in the state, according to a statement issued yesterday by the Ohio Department of Development.

As part of its tax-credit agreement, Thermo Fisher is required to maintain operations at the Marietta project site for at least 10 years, and it will invest at least $1.7 million into upgrading the facility, including $1.2 million in machinery and equipment, $300,000 in facility renovations, and $200,000 in on-site infrastructure improvements.

In March, Thermo Fisher cut 24 jobs from the same facility in Marietta. Though it declined to disclose details of the job cuts at the time, a company spokesperson said that those jobs were eliminated as part of a specific customer service function that was consolidated into the company's Asheville, NC, site.

PepsiCo Opens Nutrition Driven Research Lab

PepsiCo is opening a new research laboratory in New Haven to help “fundamentally improve” the nutritional portfolio of its products.

Taken together, PepsiCo intends for the two projects to help provide the scientific support for a nutritional overhaul of its product range.

“Ultimately, we’re trying to make it easier for consumers to lead healthier lifestyles,” said Dr. Mehmood Khan, PepsiCo chief scientific officer.

Achieving this does not simply mean reducing fat, sugar, and salt levels, and then fortifying products with health ingredients like vitamins and mineral.

In Europe, for example, PepsiCo has introduced Baked Lay’s and Baked Walkers with 70 per cent less total fat than regular crisps.

Class 8 Cleanroom Added to Omega Plastics

Omega Plastics continues its expansion into the medical device industry by completing a 3,000 square foot white room which houses a permanent Class 8 cleanroom. The white room is also accompanied by three portable cleanrooms as Omega looks to offer its clients fast and flexible molding and assembly capabilities. “We know we need to have the flexibility to support our clients’ development as well as capacity to support production,” says Chris Buch, Business Development Manager of Omega Plastics. “The addition of a large white room and another cleanroom allows us to do that for both molding and assembly.”

Omega began cleanroom molding several years ago in order to meet the demands of an ever-growing medical device client base. Omega’s many years of experience in manufacturing “project critical” engineered plastic components was a natural fit for the demands associated with white room and cleanroom molding. “The innovation happening with resins and the intensifying requirements around manufacturing quality for medical devices requires an experience supply-partner armed with the right capabilities. The addition of a white room and cleanroom is one of the ways we express our focus on being a great teammate to our medical clients,” says Jeff Kaczperski, President of Omega Plastics.

Platypus Lands $100K SBIR Grant

Platypus Technologies will use a $100,000 grant from the National Institutes of Health to develop its cell motility products for use in high-throughput screening applications, the firm said.

The one-year Small Business Innovation Research grant will support an expansion of and modifications to the current Oris 96-well cell migration assay in order to make it compatible with automated liquid handling and high content imaging systems.

Platypus Program Manager Renee Herber said in a statement that the advancements "will dramatically improve testing throughput and efficiency, while reducing the cost per assay for researchers."

The Madison, Wis.-based firm said that it has received a total of more than $18 million in NIH support to date, and that it is currently developing technology using liquid crystals for the rapid and low-cost detection of molecular interactions.

Norwich Expands Services with New Pilot Scale Facility

Norwich Pharmaceuticals has a newly built and commissioned pilot scale development facility. The new area's features state-of-the-art equipment, according to Norwich, and a company statement said the facility "offers greatly expanded contract outsourcing capabilities enabling them to work with customers earlier on in the development cycle, continuing right through scale up and commercial launch."

With the addition of compatible bench scale equipment, the facility has significantly increased its capabilities. The new equipment includes a four, eight, sixteen quart PK Blend Master with intensifier bar, an Aeromatic MP1 Fluid Bed Dryer, a Vector GMX-10 and GMX-25 Hi-Shear Mixer and a Vector FL-M-1 Flo-Coater. These new additions provide a working range of one to 25 Kgs.

Norwich also recently added new commercial large scale facility capabilities, including a Niro precision coater for the Niro MP5 commercial scale fluid bed to support customer product scale up from the development suite. This three-column coater has a volume range of 30 to 245 liters.

Toxikon Boosts Biologics Safety Program Services

Toxikon Corporation has expanded the offerings in its immunotoxicology department. To meet increased demand for biologics research, Toxikon has added flow cyctometry to its service offerings, which enables the direct analysis of cells to detect a variety of specifically labeled components.

Christopher Brynczka, Ph.D., head of immunotoxicology, clinical and histology services at Toxikon, remarked, “This is an opportunity for Toxikon to promote the development of our sponsors’ drugs and medical devices,” said Dr. Brynczka. “If there are findings related to immune function in other preclinical studies, a more extensive evaluation of immunotoxicology is often necessary.”

Immunotoxicology study designs examine the physiological functioning of the immune system and the impact treatment with a test article may have in normal function. “The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell,” said Dr. Brynczka.

A study published last fall by the Journal of the American Medical Association stated that almost 25% of biologic drugs approved in the U.S. and Europe since 1995 have been at the forefront of at least one safety-related regulatory action in the decade since initial market approval, while 11% of the biologic therapies within that one-quarter percentile have been issued a black box warning, the study revealed.

While all newly developed drugs carry risks, said a Toxikon statement, biologics are in a special class because they are derived from biological sources, including antibodies, enzymes and hormones.

The new equipment is just one of several additions Toxikon has added to its immunotoxicology department, offering everything from quantitation of splenic B and T cells to a full battery of host resistance models.

Vetter Adds U.S. Development Facility

Vetter will open Vetter Development Service (VDS), a technologically advanced customer service facility located in Chicago, IL. The site will allow the company to provide greater commitment and support toward the product needs of its North American customers, according to a Vetter statement. Vetter will be capable of aseptically filling very small quantities of products in the new facility, providing faster and more streamlined product delivery and customer service. Headquartered in Ravensburg, Germany, Vetter sees the new facility as a significant investment in Vetter Pharma International GmbH. The 25,000-sq.-ft. facility will open end of 2009.

With its new location in the heart of the U.S., Vetter can now process and test small quantities of materials by bringing the development process closer to key customers, enabling greater cooperation at the earliest stages of development and minimizing the need to transport products, according to the company.

The site is intended to facilitate a shorter time to market for Vetter's North American customers. Peter Soelkner, managing director at Vetter, remarked, “The opening of this new cutting-edge VDS facility shows Vetter’s firm, strategic commitment to the North American market by bringing the state-of-the-art technology to the heart of the U.S.,” said Peter Soelkner. “The support VDS delivers throughout the entire product development cycle can now start earlier, and the proximity to our customers will contribute to streamlining the process and delivering the final product faster.”

Althea Adds Formulation Development to Contract Services Slate

Althea Technologies has added customized formulation development services to its portfolio. The services will be overseen by newly appointed Dr. James Matsuura, who takes the title director of Formulation Development.

According to a company statement, "This investment in an experienced team of formulation and analytical scientists, along with new laboratory facilities and state-of-the-art equipment, enhances and complements Althea's existing expertise and capabilities in cGMP biologics manufacturing and aseptic filling of injectable products, and completes the full integration of development and manufacturing services available for clients from early-stage development through commercial supply."

The new formulation laboratories are an expansion to the clinical manufacturing facility located on the San Diego campus and are further supported by the analytical expertise of Windrose Analytica, which Althea acquired earlier this year. "The addition of our new formulation development laboratories is the perfect complement to our advanced protein and peptide analytical capabilities, and will allow us to bring our clients' products into the clinic with unmatched speed, efficiency and effectiveness," noted Dr. Alan Herman, vice president of Product Development & chief scientific officer.

The expanded facilities include a new development lyophilizer, which allows the group to optimize lyophilization cycles for products requiring enhanced stability. The new formulation laboratory and staff, operating closely with the analytical development group, complete Althea's product development group and enable Althea to support clients with critical development steps, as well as the manufacture of API and finished product.

ABC Laboratories Expands Biotech Development Services

Analytical Bio-Chemistry Laboratories, Columbia, MO, has expanded its offerings to include comprehensive support for large molecule development.

"This recent investment in biotech development services complements ABC's long history of ELISA, RIA and EIA experience and bioanalytical support. It also leverages ABC's extensive analytical capabilities to provide our clients with more comprehensive support for both large and small molecules," said John Bucksath, general manager and senior vice president of ABC's Pharmaceutical Services division.

To lead the development of a dedicated biotech team and laboratory, ABC recruited industry veteran, John C. Anders, Ph.D., who brings more than 24 years of experience in biopharmaceutical development from both the sponsor and CRO sides of the business. Dr. Anders has held several leadership positions building and leading advanced CGMP biotechnology analytical laboratories, and has expertise in time-tested and new technologies in protein chemistry, analytical methods and analysis of macromolecules by various methods. He played a major role in developing a pipeline of seven genomic expression tests for diagnosis and risk assessment of various types of cancer, including the successful completion of a pre-IND application to the FDA and development of a clinical protocol slated to begin soon.

Dr. Anders has assembled a team of biopharmaceutical experts, each with more than 18 years of experience in protein chemistry and chromatography. To ensure the team is well equipped to meet client demand, ABC has invested in a leading-edge biotech lab housed in ABC’s new, 90,000-sq.-ft. pharmaceutical development facility in Columbia, MO.

“Despite a challenging economic environment, 2009 was a positive year for ABC Laboratories,” said Mr. Bucksath. "Recent investments in people, processes and systems have resulted in 13% growth over 2008 and positioned us well to deliver on our customer’s needs in the years to come.”

Lonza in Manufacturing Pact with ProChon Biotech

ProChon Biotech, Ltd. has selected Lonza to manufacture its fibroblast growth factor (FGF2v) variant at its Hopkinton, MA facility. FGF2v is a key regulator of cellular processes involved in blood vessel formation, wound healing and the remodeling of bone and cartilage and is a component of ProChon's BioCart Cartilage Regeneration System.

"With an unparalleled track record in contract manufacturing, Lonza is the ideal partner to manufacture our fibroblast growth factor system," said Patrick O'Donnell, chief executive officer of ProChon. "As we accelerate the BioCart clinical program at medical centers across the country, it is vitally important to have immediate access to our core technology and working with Lonza will make this a reality. We look forward to working with Lonza to develop FGF2v as we move toward our goal of bringing mobility to millions of people who suffer from cartilage injuries."

"We are very pleased to enter this collaboration with ProChon to advance a critical new biotherapy for cartilage regeneration," said Dr. Stephan Kutzer, head of Lonza Custom Manufacturing. "We look forward to supporting ProChon with innovative development services and the latest in biopharmaceutical manufacturing technologies and expect this to be the basis for a successful, long-term relationship."

SMI, Houston, TX, Invests $10 Million in HealthSport, CA

SMI Manufacturing has agreed to invest $10 million into HealthSport, Inc., a formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion. The investment is expected to accelerate HealthSport's growth and strengthen its alliances with large pharmaceutical companies.

"The first phase of our relationship with HealthSport was accomplished in July of this year with the signing of the manufacturing agreement between the two companies. This investment represents the next step in that relationship, which is to begin the process of making this breakthrough technology available to the pharmaceutical industry on a worldwide basis," stated Kevin Taheri, SMI's chief executive officer.

"It has been apparent for some time that there is a very strong synergistic relationship between SMI and HealthSport. We are looking to take advantage of that relationship to not only produce dietary supplement and OTC film strip products, but also to begin working with pharmaceutical companies to enter the highly profitable prescription pharmaceutical market," stated Hank Durschlag, chief executive officer of HealthSport. "Our drug delivery platform is ideal for many drugs already used everyday."

SMI and HealthSport signed a stock purchase agreement pursuant to which SMI will invest the $10 million into HealthSport in exchange for a 55% percent stake in HealthSport. Closing of the transaction is anticipated to occur in the next 15 to 20 days. At the time of the closing, SMI will deliver to HealthSport $2 million and a promissory note for $8 million that SMI will pay in five installments through the final scheduled payment on June 30, 2010. Funds from the investment will be used to strengthen HealthSport's working capital position, provide funds for R&D and enhance HealthSport's current manufacturing plant, creating a state-of-the-art, GMP compliant R&D and production facility.

Metrics Study Examines Active-Only Powder-In-Capsule Dosing

Although active-only powder in capsule approaches are increasingly popular for Phase I trials, they may result in significantly slower, more erratic and less complete in vitro dissolution for some poorly soluble compounds – with the potential to skew in vivo results and delay or abandon work into promising new drugs. So says Dr. Michael Ruff, CPIP, vice president of pharmaceutical development at Metrics Inc. Dr. Ruff presented his research findings during a poster session on Nov. 9 at AAPS.

In a recent study, Dr. Ruff compared the in vitro dissolution of a non-formulated, active-only powder in capsule to that of a formulated capsule in the case of a poorly soluble drug intended for Phase I trials. He reported that his findings represent a cautionary tale for the pharmaceutical industry, which has increasingly taken an active-only, powder-in-capsule approach towards conducting Phase I first-time-in-man trials. This approach enables companies to skip significant formulation and analytical development activities and put prospective new compounds into patients more quickly.

“Going with a drug-only-in-capsule approach can move up first-time-in-man clinical dosing by two to four months, depending on the complexity of the intended dosage form,” Dr. Ruff said. But in his study examining a typically poorly soluble compound, he found that the powder-in-capsule approach resulted in significantly slower, more erratic and less complete in-vitro dissolution. This situation could potentially yield false negative in vivo results, delaying future trials or causing researchers to abandon studies of potentially beneficial new drugs, he warned.

“I recognize that there’s tremendous pressure to reach that first-in-man milestone – it’s what the industry and shareholders expect,” Dr. Ruff said. “So I’m not suggesting that researchers never do active-only powder in capsule. But this limited data supports the theory that agglomeration of micronized, poorly soluble active ingredients can pose a problem for this approach.”

Headquartered in Greenville, NC, Metrics provides pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.

Therapeutics Gets FDA Approval

Azaya Therapeutics, Inc. announced that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its lead product “ATI-1123,” a novel and improved formulation of Taxotere^® (docetaxel), a leading chemotherapy drug with worldwide annual sales of over $2.8 billion.

Azaya’s Phase I clinical study will now open for enrollment at two premier cancer research centers in Texas: South Texas Accelerated Research Therapeutics at the START Center for Cancer Care in San Antonio and The Mary Crowley Cancer Research Center in Dallas. Patients with solid tumors that have not responded to treatment with other anti-cancer agents will be enrolled in the study.

The study is designed as an open-label, dose-escalation study that will determine the safety, tolerability and pharmacokinetics of the drug. The study also provides for the collection of efficacy data.

“The FDA’s acceptance of our IND package is an important milestone in the commercialization of this important and innovative new cancer treatment,” said Michael T. Dwyer, president and CEO of Azaya. "Developing a cancer treatment such as ours takes an extraordinary amount of time and effort, and I am pleased to initiate our Phase I trial for patient enrollment,” he added.

Azaya utilizes a proprietary manufacturing process to produce liposome-encapsulated chemotherapeutics that eliminates the use of toxic carriers and incorporates a naturally occurring protein to stabilize the liposomal encapsulated drug. Preclinical studies have demonstrated improvement in the toxicology profile and an enhanced efficacy of ATI-1123 compared to Taxotere® in a number of tumor models.

University of Arizona Breaks Ground on Bioscience Park

The University of Arizona broke ground on the Bioscience Park, or Bio Park, a world-class development expected to generate stable high-paying jobs, attract capital investment for emerging industries and sustain long-term economic growth for greater Tucson and Arizona.

The 54-acre Bio Park at Kino Parkway and 36th Street will include up to 2.4 million square feet in laboratory and office space, a science and technical high school affiliated with Tucson Unified School District, hotel and conference center and University housing.

Approximately 25 percent of the Bio Park will remain open space and features courtyards and a north-south greenbelt to encourage interaction and a sense of community among employees, residents and visitors.

The Bio Park's phase one development is funded by a $4.7 million grant from the U.S. Department of Commerce, Economic Development Administration as part of the American Recovery and Reinvestment Act, known as ARRA.

The stimulus grant is one of the largest awarded by the EDA for a research park and among the largest ARRA grants awarded to the UA. The federal funds support the development of essential infrastructure including roads, water systems, utilities and perimeter landscaping.

"The new Bio Park complex will enhance the UA's competitive edge in bioscience research and

complements the efforts of southern Arizona's existing bioscience and biotechnology facilities," said UA President Robert N. Shelton.

"The Bio Park will be an important and integral part of the University," said Leslie Tolbert, UA vice president for research, graduate studies and economic development and co-chair of the Bioscience Leadership Council of Southern Arizona. "It will allow the University to link its research efforts to technology commercialization and regional economic development."

The UA announced at the event that Lincoln Property Company, or LPC, will be the development partner for the Bio Park.

In the upcoming months, the UA Office of University Research Parks and LPC will develop the Bio Park's design and development guidelines and implement a national marketing program to begin attracting and recruiting technology and bioscience tenants to the Park.

Construction for tenant space could begin quickly on the site and is not dependent on completion of the infrastructure improvements.

The Bio Park is where scientific discovery connects with entrepreneurial business so research developments can advance to the marketplace. "This park will be a global destination for innovation and collaboration," said Bruce Wright, UA associate vice president for university research parks. "Carefully planned and well conceived, the complex will attract the best and brightest minds in bioscience to southern Arizona." A master land use plan for the park was approved by the Arizona Board of Regents in June of this year.

The Bio Park is designed to provide state-of-the-art commercial bioscience facilities in Tucson and southern Arizona, Wright said. "The design includes all the components needed to support the bioscience industry and features elements and best practices from existing science and technology parks. The complex includes wet labs, clean rooms, culture labs and equipment rooms that reduce start-up costs for emerging companies and are conducive to research and commercialization. We also will have a full range of educational facilities to support workforce training."

"We are actively looking for technology companies who will enhance the vision and help make this one of the most successful bioscience parks in the world," said Molly Gilbert, project manager for the park.

Bioscience is one of the fastest growing sectors of the economy. "In Arizona, the biosciences industry is still in its early stages but growing three times faster than the national average," Wright said. "For a state that has long depended on cyclical industries that produce extreme periods of economic bust and boom, the potential return on investment in biosciences is significant, creating huge opportunities for increased private investment, increased federal funding and high-paying, stable jobs."

The Tucson metropolitan area is home to more than 100 bioscience companies and organizations.

The Bio Park campus is part of a larger 350-acre planned community called The Bridges, which will include residential housing units as well as retail establishments. This is one of the city's largest infill projects and the first major urban-core development to mix homes, stores and employment centers in a single site. Planners envision a vibrant urban center featuring grocery stores, restaurants, cafés and retail shops – amenities currently not available in the area.

The Bio Park has been in development for the past 8 years.

"Early on we wanted to connect the Bio Park to the surrounding neighborhoods and make the residents an integral part of the project," said Gilbert. "We knew that input from all the stakeholders – developers, investors, private and public partners and the community – was critical for this to be a success."

"The Bio Park marks new investment in our community. The Vistas and Pueblo Gardens neighborhoods were built back in the 1940s so that Air Force personnel had a convenient place to live near the base," said local resident Cindy Ayala. "The Bio Park is a welcome addition to this area. We are all looking forward to greater educational and employment opportunities."

"The new Bio Park will help the UA, Tucson and Arizona play a larger role in that viable economic future," Wright said.

The potential economic impact of the Bio Park is reflected in the performance of the UA Science and Technology Park at Rita Road and Interstate 10. In January, the UA released a study of the economic impact of its Tech Park, now in its 15th year. Today that park is home to 41 technology companies and business organizations and employs more than 7,000 employees earning an average of $71,000 annually – which is nearly twice the annual average wage in Pima County.

The Tech Park contributes annually nearly $2.5 billion to the Pima County economy.

The UA is a known leader in the high-tech fields of optical sciences, astronomy, astrophysics, planetary sciences, hydrology, earth sciences, medicine, biosciences and engineering

Merit Medical Systems will Expand Utah Operations

The expansion is expected to add 392 jobs over the next 10 years.

Merit Medical plans to spend more than $11 million in capital investment and training. The company's expansion is expected to generate more than $25 million in new tax revenue for the state.

The company received a state tax credit incentive from GOED, putting a cap of $4.36 million on total new state taxes paid by the company over 10 years.

The tax credits will be issued to the company annually upon verification of job creation and actual taxes paid.

Founded in 1987, Merit Medical Systems Inc. is a manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures.

Merit employs approximately 1,880 people worldwide, with Utah facilities in Salt Lake City and South Jordan.

Fairchild May Expand in Utah

Fairchild is considering investing $49.5 million to upgrade its existing West Jordan facility. State tax revenues generated by this expansion and retention project are estimated at over $5.3 million.

The GOED incentive consists of a tax credit based on 25 percent of the new state taxes paid by the company and a grant based on retaining 473 jobs in the state for 10 years. Total value of the incentives is estimated at $1,269,200.

If the GOED offer is accepted, Fairchild would convert the wafer fabrication facility from 6-inch wafer processing to 8-inch, which would improve the economic efficiency of the site.

Fairchild first started in Utah in 1974.

Roche Diagnostics Opens West Coast Training Center in Pleasanton, CA

Roche Diagnostics said that it has opened a West Coast training center in Pleasanton, CA. The new center is housed at a facility owned by Roche Molecular Systems, and will provide customers with training on the firms molecular diagnostics and clinical chemistry/immunochemistry instruments. The firm said it plans to open a similar facility on the in New Jersey next year.

Nuclea Diagnostic Received Accreditation for Lab at Clark University

Warnex Receives Money for Work at Lakehead University

Quebec-based Warnex said that it has received C$676,100 (US$639,203) from the Northern Ontario Heritage Fund to work with the Paleo-DNA Laboratory of Lakehead University to develop a forensics database. The new database will be based on mitochondrial DNA and will be the first such database in Canada.

Deltagen Acquired Benten BioServices

Harvard Halts Construction of $1 Billion Science Complex

Harvard University will "pause" construction of its $1 billion Allston Science Complex in Boston next spring upon completion of the current phase, President Drew Gilpin Faust announced in a letter this week to the university and Allston communities.

The action delays the university's plans to move its Harvard Stem Cell Institute, the Wyss Institute for Biologically Inspired Engineering, and a new department of stem cell and regenerative biology, to the new science center.

"The altered financial landscape of the University, and of the wider world, necessitates a shift away from rapid development in Allston," Faust said in her letter, released Thursday. "The most prudent course is to delay the next phase of construction while continuing a rigorous analysis of strategies for resumed activity."

That analysis will be conducted by a three-person team of Harvard professionals. They will examine options that include "co-development with private partners or other institutional partners," Katherine Lapp, Harvard's executive vice president, said in the university's official publication, the Harvard Gazette.

"We expect to take the next year to look at possible opportunities," Lapp said. "We expect to file an updated plan by the end of 2012."

During the pause, Lapp said, Harvard will redevelop space in its Cambridge and Boston (Longwood) campuses for the stem cell institute and department, and other unspecified science uses. But the Wyss institute will move primary operations from Longwood to a nearby non-Harvard building, the Center for Life Sciences, "in the early spring of 2010," Wyss director Don Ingber said in a Dec. 7 university newsletter.

Lapp said Harvard will finish in March the Allston complex's below-grade structure — namely a foundation with 8,000 tons of structural steel, and several below-grade unfinished spaces for lab support, power generation, and underground parking. That project is "93 percent" complete, she said, to be topped by a street-level concrete deck nearing completion.

Harvard slowed down construction earlier this year as the economy slipped into recession. Harvard has blamed the recession for a 27 percent plunge in its endowment in the year that ended June 30, from $36.9 billion to $26 billion.

Also during the pause, Faust said, Harvard will seek to lease out several buildings used for supporting construction operations; improve the buildings, which total 100,000 square feet; extend short-term leases on space already rented to tenants; and complete a new park and landscaping within the 350-acre site, where the 589,000-square-foot science-complex was supposed to open in 2011.

Architects Completes UC Riverside Stem Cell Core Facility Project

Kornberg Associates | Architects has converted part of an existing building (Keen Hall), including a previously unused covered open area, into an innovative stem cell core facility for the University of California, Riverside. Ken Kornberg, president and founder, made the announcement.

"A key project element was to ensure that although the facility was integrated into the campus security system, access control is independent from the rest of Keen Hall," said Kornberg Associates I Architects Principal Mike Mulvey, RIBA, who supervised the project and heads up San Diego operations for the firm. "A video monitoring system was included in the cell culture labs, support rooms and microscopy rooms for educational purposes. Portions of the adjacent 30-year-old building were brought up to current disabled access standards as part of the project."

The facility includes a cutting-edge Nikon BioStation, an automated microscopic cell culture observation device. Cameras in all working areas feed to an LCD screen in the lobby so that students and others can be shown stem cell activities without having to enter the 'clean area.'

Major project funding was provided by the California Institute for Regenerative Medicine established in 2005 following the passage of Proposition 71, the California Stem Cell Research and Cures Initiative. The statewide ballot measure provides $3 billion in funding for stem cell research at California universities and research institutions. CIRM makes grants and provides loans for stem cell research, research facilities and other research opportunities. CIRM inspected and approved the facility in August 2009.

The University of California, Riverside is one of 10 universities within the University of California system. Current enrollment is 17,187 students. The campus is located about 50 miles east of downtown Los Angeles.

Kornberg Associates I Architects (www.kornberg.com), established in 1979, is the world's oldest, independent lab/research design firm. The company provides a full range of architectural services and has completed more than 500 projects worldwide. These have included pharmaceutical and biomedical research labs, clinical care facilities, medical centers, office/administrative buildings, conference centers and schools. Project scale ranges from tenant improvement/renovation to complete buildings and campuses. Offices are located in Menlo Park and San Diego, CA; and Tokyo.

Genomics to Play Key Role in New UK Research Center

The British medical research partnership planning to build a roughly £500 million ($812 million) interdisciplinary laboratory campus in central London says genomic technologies will play a key role in the array of research its partners plan to pursue there.

Cancer Research UK, the Medical Research Council, University College London, and the Wellcome Trust will develop a single building as the new home of their partnership, called the UK Centre for Medical Research and Innovation. The UKCMRI will rise on a 1.5-hectare (3.7 acre) site bordering Brill Place and Ossulton Street, near the St. Pancras International rail station.

The UKCMRI unveiled a rendering by architect HOK London of the building, which will convey the shape of a pair of chromosomes. The facility, set to be completed in late 2014 or early 2015, will house in one location 1,500 employees — including a projected 1,250 researchers from the MRC's National Institute for Medical Research, and from CRUK's London Research Institute.

The National Institute for Medical Research scientists are now based just outside London in Mill Hill, while the LRI has personnel split between central London and South Mimms, Hertfordshire.

"The sheer size of UKCMRI will allow genomics to become an integral part of a broad spectrum of research approaches at the Institute," said Edward Staite, a spokesman for the center. "UKCMRI will recruit research groups using these technologies as their primary research avenue to answer particular biological questions, and its interactive culture will encourage them to work collaboratively with those using other approaches."

"In addition, the comprehensive core technology facilities at UKCMRI will include cutting-edge mass spectrometry, genomics, high throughput RNAi and chemical biology screening platforms, which will be available to institute researchers," Staite added.

UKCMRI says genomics and other technologies will be applied toward its four key goals: research excellence, supporting the UK's biomedical research effort, recruiting and training researchers, and fostering translation of discoveries into new treatments against disease.

"The Centre's broad research remit will address fundamental problems relevant to cardiovascular and circulatory disease, cancer, infection, immunity, tissue and organ development, degeneration and regeneration, and diseases of the brain and nervous system," UKCMRI said in a statement of its scientific vision and research strategy. "It will build on recent advances in human genetics and genetically diverse population studies to investigate human biology."

"UKCMRI will probably be the most exciting project for UK biomedical research in the next 50 years," Scientific Director Sir Paul Nurse, a Nobel laureate and president of New York's Rockefeller University, said in the statement.

Once the center's science programs are finalized, detailed planning will proceed on which labs from the partners will be moved into the new center. Researchers from LRI and NIMR will form the core of the new facility, Staite said, though UCL is expected to provide mathematicians, chemists, engineers, and computer scientists.

UKCMRI will not conduct clinical trials at the new facility, but partner with area hospitals. Staite said the center is confident that University College London Hospital will work with it, and also hopes to team up with UCL's specialized hospitals in London, including Great Ormond Street Hospital for Children, the Hospital for Tropical Diseases, the National Hospital for Neurology and Neurosurgery, and Moorfields Eye Hospital.

The UKCMRI site — purchased for £85 million from the British government, which rejected higher bids from other would-be buyers — is just north of the British Library, which will work with the center on joint research projects as well as new bioinformatics resources.

Those efforts fall within the center's aim of positioning the UK as a global leader in medical research, on a par with campuses in the US and Asia.

"UKCMRI provides the potential for the UK to compete and collaborate with other global hubs of scientific and medical excellence, such as the Allston Initiative at Harvard and the Howard Hughes Medical Janelia Farm Research Complex in the US, and Biopolis in Singapore," Wellcome Trust said in a September statement to the House of Lords' Science and Technology Committee.

Between 45 and 50 percent of building costs would be paid for by the Medical Research Council, its Chief Executive, Sir Leszek Borysiewicz, said at a Dec. 7 press conference. Of the remaining cost, he said between 25 percent and 30 percent from Cancer Research UK, a firm 20 percent from Wellcome Trust, and between 5 percent and 10 percent from University College London.

The Medical Research Council will raise funds by selling its Mill Hill property, while CRUK will likewise find a buyer for LRI's facility at Lincoln's Inn Fields site. "Details of this are commercially sensitive and we cannot disclose further information," Staite told GWDN.

As for operational costs, Staite said that those will initially be funded through core funding to Cancer Research UK and the Medical Research Council, at levels comparable to the budgets of the current LRI and NIMR. LRI is the largest of five regional institutes funded with about one-third of the £355 million spent by CRUK on research; a precise figure was not immediately available. The NIMR operates on a £25 million per year budget.

Other operational costs, he said, will come from Wellcome Trust and the other groups involved in funding development of the center.

Even if money is ultimately no obstacle, UKCMRI faces another potential hurdle. Many opponents have promised to stop the project because it would test on smaller animals; and would include a high category 3 lab, allowing for study of some infectious diseases such as flu viruses. Opponents have said that the proposed center would be too close to homes near the project site, and that officials should instead stick to earlier plans for creating below-market "affordable" housing on the site.

The UKCMRI has ruled out tests on larger mammals such as primates, cats, and dogs, though not on smaller ones like mice and rats. And the center has said it won't study the most dangerous pathogens, such as the Ebola virus, which are restricted to category 4 labs.

"We have begun to talk to local residents about our plans – to keep people informed and hear their views," Staite said, citing public discussions to be held from today through Saturday. "This will include ongoing dialogue with local politicians and community groups, as well as key stakeholders and third parties."

Because UKCMRI is funded by charitable donations and taxpayers' money awarded on the premise it will be spent on medical research, "it is therefore not appropriate to spend charitable and public money on the development of housing," he added.

Plans for UKCMRI were first announced in 2007, and won support from Prime Minister Gordon Brown. He and his Labor party seek re-election in the general election scheduled for June, while votes for members of local councils will be held a month earlier. Several polls have shown Labor's popularity trailing the opposition Conservative party led by David Cameron, but still ahead of the Liberal Democrat party led by Nick Clegg.

Staite said the general election won't affect the timing of the planning application, to be filed with the Camden Council in the spring. "Our proposals will be considered after the local elections in May 2010."

"We believe all political parties understand the strategic importance of UKCMRI for London and the UK as a whole," Staite added.

U.S. have been selected as Category Winners in the Sixth Annual Facility of the Year Awards

(The 6^th Annual Facility of the Year Awards (FOYA) program is sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.

The winning companies and respective award categories include:

Biogen Idec, winner of the Facility of the Year Award for Operational Excellence for its facility in Research Triangle Park, NC.

Genentech, winner of the Facility of the Year Award for Project Execution for its facility in Tuas, Singapore

MannKind Corporation, winner of the Facility of the Year Award for both Equipment Innovation and Process Innovation for its facility in Connecticut, U.S.

Pfizer Biotechnology Ireland, winner of the Facility of the Year Award for Sustainability for its facility in County Cork, Ireland

Pfizer Ireland Pharmaceuticals, winner of the Facility of the Year Award for Facility Integration for its facility in Dublin, Ireland

The Facility of the Year Awards program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now in its fifth year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.

The Facility of the Year Awards program is truly global, as submissions over the past six years have been received from more than 25 different countries and territories. Each of the submissions was reviewed by an independent, blue-ribbon judging panel of global representatives from the pharmaceutical design, construction, and manufacturing sectors.

Facility of the Year Award Winner for Operational Excellence: Biogen Idec

The over-arching mission of Biogen Idec’s global Technology Map Program was to upgrade the infrastructure of the company’s bulk biologics production facilities and reduce challenges associated with downstream processing bottlenecks. The program involved analyzing the assets in its facilities, evaluating new technologies, preparing for newly developed processes, incorporating sustainability methods, and balancing current commercial operations with future strategic capabilities to support the company’s growing product pipeline.

Upon conclusion of the Large Scale Manufacturing (LSM) Technology Map project at the company’s world-class Research Triangle Park, North Carolina, USA site, Biogen Idec completed the largest renovation of a licensed manufacturing facility in the company’s 30-year history. The upgraded facility provides a 300% increase in yield over its previous production output by incorporating new technologies and de-bottlenecking operations at an existing site at a fraction of the cost of building new facilities. The resulting higher throughput comes, in part, from facility and equipment improvements that achieve faster and more streamlined technology transfers and process changeovers within the multi-product facility. It further provides more flexibility to take advantage of increasing external collaborations and acquisitions.

The project team, including IPS, Yonkers and CAI, successfully implemented and achieved this strategic upgrade utilizing exceptional up-front project planning; project management; integrated, lean design and construction techniques; and rolling plant shut-downs at a scale that few, if any, have attempted to execute at one time.

Facility of the Year Award Winner for Project Execution: Genentech

Genentech’s bacterial manufacturing facility was built in Tuas, Singapore to increase the production capacity of Lucentis? (ranibizumab injection), which is used to treat patients with wet age-related macular degeneration. Genentech established a highly ambitious schedule that would be the defining challenge: to take a project from engineering kick-off through initiation of GMP qualification batches in 24 months. The facility was initially developed by Genentech, a wholly owned member of the Roche Group, and is now operating as Roche Singapore Technical Operations.

Meeting an ultra-fast-track schedule on an international project required a collaborative team to develop and execute an innovative strategy. With its contractors Jacobs Engineering Group and Bovis Lend Lease Pharmaceutical, Genentech developed a strategy utilizing large-bay modules integrated with traditional stick build construction. The team also developed a parallel work strategy that enabled a 90% overlap of design and construction efforts ? as well as the most aggressive qualification and validation schedule ever attempted by Genentech for a facility of this scale and type leading to significant overall schedule savings. With design activity taking place in four locations spanning 12 time zones, the Genentech team selected “typical” design tools and procedures to eliminate learning curves, and their online, real-time data model allowed immediate design review and comment. This online process proved so effective that planned on-site reviews were greatly reduced, saving travel costs and time, as well as the lag between design and design approval.

As with any project of this size and complexity, the Genentech team encountered numerous challenges but overcame each through outstanding project execution techniques. The team’s planning, dedication, and innovation enabled delivery of a fully integrated, high-quality facility in record time.

Facility of the Year Award Winner for Equipment Innovation and Process Innovation: MannKind Corporation
MannKind Corporations’ signature drug, an ultra rapid-acting insulin therapy, was developed to offer the millions of people suffering from diabetes a non-invasive treatment option. At the heart of the drug lies MannKind’s proprietary Technosphere molecule that can deliver not only insulin, but also a wide variety of other macromolecules into systemic circulation through the pulmonary route. The Technosphere particle and Technosphere Insulin (TI) were so revolutionary and specialized that no existing facility in the world was capable of producing them. For this reason, the company designed and built its own production facility.

While the facility itself is a striking merger of form, function, and efficiency, it is the custom process line it houses that impressed the judging panel and inspired them to also award this project the Facility of the Year Award for Process Innovation. MannKind engineered an innovative manufacturing process line from start to finish. It begins with the creation of the Technosphere particle itself. The particle is then combined with insulin in a specialty mixer, and the resultant slurry is freeze-dried to isolate the powder. Once dried, the powder is transported to the fillers, and then filled into capsules and packaged for distribution. At every point in this process, MannKind designed new technology or applied innovative adaptations to existing technology to meet their needs.

Begun in early 2007 and completed in mid-2008, another distinguishing feature of MannKind’s $163 million, 23,400 square meter facility is a first-ever solid-dosage pharmaceutical adaptation of a cryopelletizer, for which the judges awarded the Facility of the Year for Equipment Innovation. MannKind worked with Cryogenic Equipment Services to modify the cryopelletizer to create uniform pellets from the slurry so that the water could be removed quickly and consistently during the bulk lyophilisation process. This revolutionary adaptation dramatically improved the quality of the drug and the efficiency of its production. In addition to the new lyophilization technique, MannKind also made unique adaptations to the specialty mixer where the TI particle and the insulin are combined; designed a highly cost-effective method to move bulk powder from the lyophilizer to the filler; and designed a filling system that could work at high speed while remaining safe for the operators and supremely precise in the metering of the bulk powder. All test batches and full-scale development batches of TI were produced successfully in the new facility.

Facility of the Year Award Winner for Sustainability: Pfizer Biotechnology Ireland

Pfizer Biotechnology’s Ireland’s Monoclonal Antibodies Small-scale Facility was built using industry best practices for sustainability and Pfizer’s green building guidelines that included the extensive re-use of existing assets, waste minimization procedures, recycling utilization in both construction and operations, the inclusion of energy-efficient fixtures and equipment, and minimized air change rates to meet comfort conditions and classification standards.

This Phase 2B/3 clinical trial product facility is Pfizer’s first biotechnology greenfield development and the site was chosen for a variety of reasons, including its proximity to the adjacent Pfizer Ringaskiddy site which allowed the new facility to use spare capacity of the existing wastewater treatment plant and fire main system rather than building a new treatment plant or bringing in new tanks and pumps for fire water retention. Other outstanding sustainability elements of this project included the re-use of 5,000 cube meters of crushed rubble from an old adjacent facility for the new facility substructure and 30,000 cubic meters of excavated material for general site fill and landscaping; the use of an eco-seal, grey, insulated roof membrane to reduce the heat island effect; and site orientation to optimize solar gain.

The project was executed with an excellent safety record and delivered on target according to a very aggressive timeline of 29 months, 35% better than the biotechnology industry benchmark average.

2010 Facility of the Year Events

There will be several opportunities to meet the 2009 Facility of the Year Award Winners and learn first-hand about the facilities being honored as “best in their class.” These events include:

INTERPHEX2010 – Meet the Category Award Winners at the Facility of the Year Awards Display Area at booth number 1059 in the exhibit hall of the Jacob K. Javits Convention Center. This is your opportunity to meet personally with representatives from companies of the Category Winners to discuss the success stories associated with these pharmaceutical manufacturing facilities. To register or for more information, visit www.interphex.com .

ISPE 2010 Annual Meeting – Learn first-hand who the Overall Winner of the coveted 2010 Facility of the Year Award is during ISPE’s 2010 Annual Meeting, 7-10 November in Orlando, Florida, USA. For more information, visit www.ISPE.org .

At each event, a Facility of the Year Awards display will feature the 2010 Category Award Winners. Additionally, comprehensive coverage and publicity will be conducted by ISPE and Pharmaceutical Engineering magazine, INTERPHEX, and Pharmaceutical Processing magazine.

Visit www.facilityoftheyear.org for more information about the awards program and detailed information about each Category Winner’s project participants.

REST OF WORLD

GSK to Shift Avodart Production to Poland in 2011

GSK says it will start making its BPH drug Avodart (dutasteride) at its facility in Poznan, Poland when it completes a PLN70m (€17m) capacity upgrade in January next year.

The UK drugmaker said that the plant, which will take over production from a facility in France, will be fitted out with PLN54m worth of new manufacturing equipment and produce around 600m Avodart soft gelatin capsules each year

GlaxoSmithKline (GSK) Poland said that while the move is motivated by a desire to reduce costs, the transfer also indicates the breadth of its global drug manufacturing network.

Jerzy Toczyski, president of GSK Poland, explained that: “The fact that the product will be manufactured and packaged in Poznan shows great potential and confidence [in the unit’s facilities and personnel].”

The plant, which has been the focus of some PLN400m of infrastructure investment since GSK acquired it from Polfa Pozana in 1998, will supply Avodart to around 80 pharmaceutical markets around the world.

Over-clad Kalzip Solution for Influenza Resource Centre

Straight and smooth curved Kalzip aluminum standing seam and galvanized liner sheets have been used to create the tightly sealed, insulated and weatherproofed building envelope of the Influenza Resource Centre (IRC) & UK Stem Cell Bank in South Mimms. The Kalzip is over-clad in white chestnut timber to satisfy local planning requirements for this environmentally sensitive rural location. NIBSC (National Institute for Biological Standards & Control - a centre of the Health Protection Agency) appointed Design & Build contractor, Morgan Ashurst to do the construction work with cross-discipline design consultants, Morgan Professional Services (MPS) handling the detailed design and site support stage of the project.

As the IRC comprises mostly classified cleanroom laboratories, the main concern beforehand was to provide a well insulated and weatherproofed envelope capable of keeping out all external contaminants and preventing any internal biological agents from escaping into the environment. "Kalzip was the obvious choice to achieve the suitably sealed envelope with an efficient rainwater management system and able to cope with the structural loading of the timber rain screen required to achieve the aesthetic appearance of this uniquely designed building," says MPS Design Manager, David Downing.

After consulting with Kalzip's technical team, MPS produced a specification with indicative details for each cladding junction. At this point, Kalzip's Approved Teamkal Contractor, Rossway Dowd became involved and took responsibility for the external envelope. A series of design development meetings followed which resulted in the production of a comprehensive set of detailed drawings.

As a precautionary measure, Rossway Dowd then produced a full scale 'Test Rig' mock-up of the complex curved part of the roof area in their workshops in order to pre-test the proposed design solution rather than risk dealing with any unforeseen problems on-site. This proved to be a wise decision as it highlighted a few issues that had not been evident from the drawings. "It was this proactive approach in achieving the correct design solution that led to the successful installation of the building envelope which meets the client's high expectations," concludes David Downing.

The solution involves the use of straight and curved extruded aluminum T-section supports which form a series of continuous vertical ribs along the building's length to create the desired envelope shape. The T-section supports are mounted on angle brackets attached to Kalzip aluminum seam clips that are fastened to the standing seam without penetrating the Kalzip. A continuous hidden gutter is installed just above top window level and 6 meter lengths of white chestnut cladding are affixed to the T-section supports in staggered formation to form the rain screen.

Employing this over-cladding construction technique means that an infinite variety of creative design options are available to architects by using the Kalzip standing seam system to insulate and weatherproof the building envelope and carry virtually any type of rain screen cladding as an aesthetic façade.

bioMerieux Acquires Chinese Rapid Test Manufacturer Meikang Biotech

bioMerieux announced the acquisition of the rapid test manufacturer, Meikang Biotech, and its large production site in Shanghai. This important milestone will reinforce bioMerieux's position in the Point of Care and rapid test markets for both emerging and developed countries. The acquisition highlights bioMerieux's continued business expansion in fast-growing emerging markets, giving the company fully-owned, integrated manufacturing and R&D capabilities in China.

"With this acquisition, we are gaining a strategic foothold in China, the country that should drive the most growth in the next 10 years, and significant assets to enhance our product offering for Point of Care, a segment with a double digit annual growth rate. We are now poised to become a major player in Point of Care with manual rapid tests including the QuickVue range and the automated handheld device from our Philips partnership announced last week," said Stephane Bancel, bioMerieux Chief Executive Officer. "This also represents a significant step in the globalization of our company: bioMerieux will now have leaders based in three corporate hubs, in Marcy l'Etoile, France, Cambridge, USA and Shanghai, China."

Pharmaron Acquires Bridge Laboratories China

PhArmaron Holdings Ltd. has acquired Bridge Laboratories China, a provider of GLP-compliant toxicology services to pharma and biopharmaceutical companies. With this acquisition, Pharmaron becomes an integrated CRO in China supporting clients with drug discovery and development processes in support of IND filings. Bridge Laboratories China has 84,000 sq. ft. of facilities, including animal vivariums that are both AAALAC multi-species accredited and U.S. GLP-compliant. Terms of the acquisition were not disclosed.

“Pharmaron has built an exceptional team of scientists specialized in the areas of discovery and process chemistry, biology, DMPK, pharmacology and GMP manufacturing. The acquisition of Bridge Laboratories China enhances our drug R&D service capabilities by adding world-class expertise in western standard GLP-compliant toxicology and safety pharmacology to our diverse service portfolio,” said Pharmaron chairman and chief executive officer Dr. Boliang Lou. “Pharmaron is now the first CRO in China to provide fully integrated drug discovery and development services, from discovery chemistry to IND filings.”

“As a premier provider of drug discovery services, Pharmaron was an ideal partner given the company’s diverse customer base of leading biotech and pharmaceutical companies,” said Bridge Laboratories chief executive officer Tom Oakley. “The addition of Bridge’s U.S. GLP-compliant toxicology expertise will make Pharmaron the first company in China to provide truly integrated drug development services from discovery to IND.”

Johns Hopkins and Saudi Collaborate on Eye Research

The Wilmer Eye Institute of Johns Hopkins Medicine has announced that it will collaborate in research, education and patient care with the King Khaled Eye Specialist Hospital in Riyadh, Saudi Arabia.

The King Khaled Eye Specialist Hospital is the largest eye hospital in Saudi Arabia, and is one of the top-ranked medical facilities in the Middle East.

Gerresheimer and Novo Nordisk Set up New Production Facility in Brazil

The Gerresheimer Group has set up a new facility for medical plastic systems in Indaiatuba (Brazil). The plant is to commence operations early in 2010. On the basis of a long-term cooperation agreement with Novo Nordisk, components will be produced with state-of-the-art technology for insulin pen systems for diabetics.

Insulin pens are drug-delivery devices in ball-point pen format which allow diabetes patients to inject themselves with the regularly required insulin dose safely and almost painlessly. Novo Nordisk as the world's leading insulin producer has contracted Gerresheimer to manufacture components for its insulin pens. Novo Nordisk has a large insulin plant in Brazil which will in future be supplied locally by the new technology center of the Gerresheimer Group. For Gerresheimer this is already the fourth production plant in South America in addition to two existing plants for standardized pharma plastic packaging in Brazil and one in Argentina.

Apart from the new production facility in Brazil, Gerresheimer already has two other production facilities for pen systems in Europe.

"Cooperation with Novo Nordisk in Brazil is of substantial strategic importance for us. We support the customer in developing new markets and at the same time expand our technological base in South America," says Gerresheimer CEO Dr. Axel Herberg.

New U.K. Center for Regenerative Medicine to Receive Over $13M in Funding

A regenerative medicine manufacturing center is to be established at the University of Loughborough with a portion of a £70 million (about $111.49 million) U.K. Government investment. The Engineering and Physical Sciences Research Council (EPSRC) Centre for Innovative Manufacturing in Regenerative Medicine will carry out research and test new ideas in clinical and industrial settings.

The center aims to create next-generation platforms for manufacturing regenerative medicines and inform business models, policy, and public debate. Investment from the EPSRC will total £5.3 million (roughly $8.44 million) over five years, with 28 industrial and government partners contributing an additional £3 million (approximately $4.78 million).

The £70 million government funding also includes the established of a Centre for Innovative Manufacturing in Photonics at the University of Southampton and a Centre for Innovative Manufacturing in Liquid Metal Engineering at Brunel University in London.

Zydus Cadila Indian Pharma to Begin Clinical Trials

Zydus Cadila has become the first Indian pharma company to begin multi-centre clinical trials of a H1N1 vaccine after it received approval from the Drug Controller General of India (DCGI).

The company believes that demand for H1N1 vaccine in India in the initial phase will be 50 to 60m doses. Zydus is now positioned to be the first Indian company to develop a H1N1 vaccine, with a predicted launch date of April 2010, giving it an opportunity to capture a slice of the market.

Pankaj Patel, chairman and managing director of Zydus, said that the company’s “researchers and vaccine experts have worked round-the-clock to strengthen our armory in this fight against the H1N1 virus”.

This team of researchers has developed an egg-based, inactivated H1N1 vaccine which will now enter clinical trials. Zydus is hoping for a speedy completion of these trials and fast track approvals to help it reach the market by April.

The H1N1 approval is the latest step in Zydus’ efforts to strengthen its vaccine capabilities. This has seen it set up a vaccine technology centre and receive World Health Organization (WHO) prequalification for its rabies vaccine.

Dubai establishes Nucleotide Research Complex

The Nucleotide Research Complex, the largest such facility in the Middle East, is now operational and ready to house companies’ research and development, analytical, diagnostic and equipment training activities.

Dubai is attempting to create a knowledge economy by using significant amounts of money and incentives to attract pharma, biotech and associated service companies to the emirate.

This has resulted in some big pharma and contract research organizations (CRO), including Pfizer and Ergomed, establishing operations in Dubai and the Nucleotide Research Complex is intended to continue this trend.

The four storey complex includes 256,000 sq. ft. of leasable area and 160 level III biosafety laboratory units. Dubai Biotechnology and Research Park (DuBiotech), the organization behind the project, believes this is an attractive proposition for biotech, life science and pharma companies.

Marco Baccanti, executive director of DuBiotech, explained that “the Nucleotide Lab Complex is the biggest laboratory facility in the Middle East”, adding that it will house “some of the world’s most talented researchers and business development managers”.

DuBiotech claims that the ground floor of the complex is already fully booked, with tenants currently installing instruments and finalizing fit-outs, and is now seeking residents for the remaining space.

DuBiotech was established in 2005 with the goal of creating the biggest life sciences cluster in the Middle East. To achieve this goal the emirate has attempted to put in place the infrastructure and incentives needed to attract pharma and biotech companies.

Despite the difficulties facing the pharma sector, and the wider economy, the DuBiotech life sciences cluster grew in 2009 from 46 to 65 business partners.

CBI and GL Merger to Create World’s Largest Preclinical Peptide Supplier

US CRO Commonwealth Biotechnologies (CBI) is moving forward with plans to buy Chinese peptide supplier GL Biochem.

The acquisition, first mooted in October 2009, is designed to expand CBI’s presence in the global custom peptides market, which the firm predicts could be worth as much as $990m (€686m) this year.

Under the proposed deal CBI will receive all of the stock of the GL Biochem’s holding company, Wise Century Group, from its current shareholder in return for 78 per cent of its then-outstanding shares.

The merger, which still needs shareholder approval, will create the world’s largest supplier of preclinical peptide reagents and custom peptide synthesis services, demand for which is likely to increase according to Virginia-based CBI.

The firm explained that: “Large pharmaceutical and biotechnology companies typically have limited capabilities in-house but choose to outsource much of their research and development work to specialist providers such as GL Biochem.

“Pharmaceutical companies are now unable to generate the large number of necessary candidate compounds in-house, and this phenomenon has led to an increasing trend for outsourcing of drug discovery research.”

Shanghai, China-headquartered GL, its workforce of over 800 employees and two manufacturing facilities, are also a good fit for CBI in terms of its wider growth strategy in the emerging Asia-Pacific drug discovery sector.

The U.S. contract research organization (CRO) already owns a research unit in Shanghai through its Hong Kong-based subsidiary Venturepharm, which also has operations in Japan specializing in process scale-up, formulation development, manufacturing and clinical trial management.

Additionally, CBI also operates a dedicated peptide discovery and research organizations with its Sydney, Australia-based Mimotopes unit.

Lab Research Develops First Simultaneous Cardiopulmonary Monitor

Lab Research (LR) claims it is the first preclinical CRO laboratory to develop a cardiopulmonary monitoring telemetry system.

The Canadian contract research organization (CRO) said that the system provides real time quantitative pulmonary monitoring of cardiovascular and respiratory parameters in conscious freely moving animals.

LR went on to explain that the ability to monitor both parameters simultaneously allows for more accurate interpretations of safety results in preclinical cal drug development.

The firm also suggested that the technology, which is expected to enter the good laboratory practice (GLP) validation process sometime this year, will offer significant time and resource management benefits.

CEO Luc Mainville said that completion of the project: "Signals our continued efforts to validate novel laboratory systems that offer alternatives to or reduced reliance on the use of animals for research and development.

“The improvement in interpretation of safety pharmacology results and allocation of valuable resources during the drug development process will greatly benefit our clients while reducing the total number of animals used in such studies by 80%.

Mainville added that LR hopes to make the technology available to its pharmaceutical industry clients for preclinical drug development and safety testing projects before the end of the year.

The new technology follows hot on the heels of a three year, C$65m (€41.8) laboratory expansion program at LR’s facilities in Denmark and Hungary.

Med BioGene Plans Expansion

Med BioGene was founded in 2002 and its state-of-the-art laboratory and offices are located in Discovery Park on the University of British Columbia campus. Med BioGene's common shares are listed on the TSX Venture Exchange under the symbol "MBI".

MBI is a life science company focused on the development and commercialization of genomic-based personalized clinical laboratory diagnostic tests. MBI is committed to advancing personalized medicine by commercializing tests that provide clinically relevant information to improve patient treatment and reduce health care costs.

Luitpold Buys PharmaForce for Generic Injectables

Daiichi-Sankyo subsidiary Luitpold Pharmaceuticals has acquired PharmaForce, giving it a 40,000 sq. ft. cGMP compliant sterile manufacturing facility and a 20,000 sq. ft. API production plant.

The deal is part of Luitpold’s efforts to diversify its product portfolio and generate growth. In particular Luitpold has identified the generic injectable market as a growth opportunity.

By acquiring PharmaForce it has strengthened its position in the market for difficult to manufacture sterile drugs and generic injectables and bolstered R&D and production capacity.

In addition to the current good manufacturing practice (cGMP) compliant facility and the active pharmaceutical ingredient (API) production plant the deal also includes a 20,000 sq ft R&D site.

Daiichi-Sankyo, which owns Luitpold, is planning to use Ranbaxy Laboratories’, also owned by the Japan-based pharma, presence in Africa to launch a product in six countries on the continent.

In December 2009 Daiichi outlined its intention for Ranbaxy to launch Olmesartan Medoxomil, originally discovered by the Japanese pharma, in Kenya, Mozambique, Nigeria, Tanzania, Uganda and Zambia. This will use Ranbaxy’s established presence in Africa and is a continuation of Daiichi’s efforts to benefit from the companies’ respective strengths following its $4.5bn (€3.1bn) acquisition of the Indian generics firm.

Germany Building Center for Cancer, Neurodegenerative Protein Biomarker Research

The government of Germany has committed at least €37 million [$53 million] to create what is expected to be Europe's largest center devoted to developing new protein biomarkers for cancer and Alzheimer's and Parkinson's diseases.

The German state of North Rhine-Westphalia provided the funding to create a new research facility at Ruhr University Bochum where scientists will attempt to discover, verify, and validate new biomarkers, and develop test kits based on them.

Construction of the 65,000-square-foot facility is slated to begin next year and to be completed in 2013. When finished, it will house about 150 researchers and administrative staff, according to Helmut Meyer, one of four researchers who will lead the center, currently called the European Protein Research Institute PURE (Protein Research Unit Ruhr within Europe).

Negotiations are under way with the German research organization Fraunhofer Society to rename it the Fraunhofer Institute for Protein Analytics and Biomarker Development, said Meyer, who is also director of the Medical Proteome Center at Ruhr University Bochum.

Planning for the center and negotiations for its funding began about two and a half years ago, said Meyer, who estimated that when all is said and done, funding could reach about €100 million [$143 million] during the next five years.

The money will come from the North Rhine-Westphalia Ministry for Innovation, Science, Research & Technology, the German federal government, and the German Social Accident Insurance, an umbrella organization of insurance institutions that provides coverage for occupational accidents and diseases.

The center will use the funding to hire new personnel and purchase new equipment, including an Orbitrap mass spec from Thermo Fisher Scientific; a MALDI mass spec; a system for laser microdissection; and a platform for infrared spectroscopy or Raman spectroscopy.

Initially, the center will direct research at the discovery of novel biomarkers for cancer — specifically bladder, liver, and lung — and for Alzheimer's and Parkinson's diseases.

The three cancers were chosen because they are of special interest to the German government, which is exploring whether certain jobs may contribute to workers developing those diseases, Meyer said.

"We have many people who have a higher risk to get such a disease … and those people are regularly tested yearly or every other year [to see] if they have any increased risk of getting sick," he said. The goal of the PURE research would be to discover and develop better methods of diagnosing individuals with disease at an early stage "before it's too late" for to medical intervention.

In addition to Meyer, another center head is Thomas Brüning, director of the Research Institute of Occupational Medicine German Social Accident Insurance at Ruhr University Bochum. Klaus Gerwert, chair of the biophysics department at Ruhr University of Bochum; and Jens Wiltfang, a professor in psychiatry and psychotherapy at the University Hospital in Essen, are the other two heads.

In the area of Alzheimer's and Parkinson's diseases, PURE researchers are following "new routes and new hypotheses" that explore autoimmune-related antibodies, "which may show up very early in the course of such a disease," up to 20 years before clinical symptoms appear, Meyer said.

By the time symptoms appear, the diseases are at a stage when treatments for slowing down their progression are extremely difficult, if not impossible, he said, and the hope is to catch them at a point when therapeutics may have efficacy.

While he and his colleagues wait for the center to be built, additional space at Ruhr University Bochum has been allotted for research related to PURE, and work is already being carried out there and at the University Duisburg-Essen.

At least in the beginning stages, some of the research builds on Meyer's work. Meyer is co-chair of the Human Brain Proteome Project of the Human Proteome Organization and has done extensive research on a broad range of diseases and proteomics-related subjects. As a result, he said, he has firsthand knowledge about what doesn't work and what could be done to achieve greater success in proteomics research.

Indeed, rather than dong high-throughput proteomics, the center will use a strategy called "high-performance proteomics." In a 2007 article in Proteomics describing the approach, Meyer and his co-authors said that the problem with a high-throughput approach is that it leads to a long list of "qualitatively identified proteins" that may not actually be indicative of disease states.

Dubai Establishes Nucleotide Research Complex

Dubai is attempting to create a knowledge economy by using significant amounts of money and incentives to attract pharma, biotech and associated service companies to the emirate.

The four storey complex includes 256,000 sq. ft. of leasable area and 160 Level III Biosafety laboratory units. Dubai Biotechnology and Research Park (DuBiotech), the organization behind the project, believes this is an attractive proposition for biotech, life science and pharma companies.

Despite the difficulties facing the pharma sector, and the wider economy, the DuBiotech life sciences cluster grew in 2009 from 46 to 65 business partners.

Jubilant Plans New Niacinamide Facility

Jubilant Organosys will build a new niacinamide and 3-Cyanopyridine plant to cater for growing demand in the drug and nutrition industries.

The facility, which is expected to be operational at the end of next year, will produce 10,000 tons of each compound per year primarily for the vitamin B3 manufacturing industry as Jubilant CEO Pramod Yadav explained.

“Our decision to set up a new facility for niacinamide reflects our commitment to our customers and vitamin B3 market. Through our in-house research we have developed a very cost efficient and environmental friendly process for the manufacture of these products which will translate into value for our customers.”

For the pharmaceutical industry, the custom research and manufacturing service (CRAMS) firm’s new facility will increase the global supply of key components for a wide range of products, including diabetes treatments and blood pressure drugs.

Merck & Co to Buy Avecia Biologics

US drug major Merck & Co will buy into the UK's contract biologics manufacturing sector with the acquisition of Tees Valley-based Avecia Biologics.

The unit, currently part of privately owned Avecia Investments, comprises a process development and scale-up manufacturing facility in Billingham that employs around 500 people in the production of drugs for cancers, heart disease and stroke.

One of these drugs, according to the Associated Press, is an anti-inflammatory owned by Dyax that is soon to be launched under the Kalbitor brand name.

Merck, which will also acquire Avecia’s existing manufacturing contracts, said it will speak with the UK firm’s customers about ongoing requirements after the deal is concluded next year.

Like many Big Pharma firms facing the loss of patents on top selling drugs, Merck has been ramping up its biologics capacity, beginning last December with the launch of its BioVentures unit, which will make both branded and generic biotech drugs.

Merck followed this up with, in February, the $130m acquisition of a manufacturing facility from fellow US group Insmed and, in November, with the addition of biologics capacity owned by Schering-Plough after the firms’ $41bn mega-merger.

The move also comes at the end of a busy few weeks for the UK sector that has seen GlaxoSmithKline (GSK) confirm plans to invest in a new biomanufacturing facility and, more recently, Recipharma move for contract manufacturer Cobra.

John McCubbins, SVP of biologics and therapeutics at Merck’s manufacturing unit, said the deal is part of the firm’s ongoing biologics expansion strategy.

He added that: “This transaction follows an initial strategic development and supply relationship with Avecia Biologics and will provide us with an operational facility staffed by an experienced workforce that is highly skilled in a broad portfolio of bioprocess systems."

In response, Steve Bagshaw, Avecia’s president, said the deal recognizes his firm’s ten year track record in biologics production and bioprocess development and “provides the exciting opportunity to focus on advancing Merck's broad early and mid-stage portfolio of biologic candidates."

Avecia’s US contract oligonucleotides production business, based in Milford, Massachusetts, is part of the Merck acquisition.

Center for Nanomedicine in Copenhagen

A 34 MDKK grant will be used to establish a Center for biomembranes in nanomedicine at the University of Copenhagen.

The grant comes from the Lundbeck foundation. Work at the centre will be focused on the basic biological processes that occur in the cell membrane, and that makes it possible for cells to communicate by transferring chemical signals. The researchers hope that the results will contribute to new ways to treat diseases of the brain, bacterial infections, biological nanosensors for diagnostics, and drug delivery systems for targeting cancer cells.

About Nano Connect Scandinavia

Nano Connect Scandinavia is an EU-funded collaboration project involving eight universities and institutes, as well as five regional public bodies, in Sweden and Denmark. The objective is to boost nanoscience and nanotechnology in the region and to increase the commercialization of research.

DKK 30 Million to New Nanomedicine Center

Aarhus University has been awarded a grant of DKK 30 million by The Lundbeck Foundation to build a nanomedicine research centre.

The management consists of Professor Allan Flyvbjerg, Specialist Physician, Faculty of Health Sciences, Aarhus University and the Aarhus University Hospital, and Professor Jørgen Kjems, Department of Molecular Biology and Vice-director of the Interdisciplinary Nanoscience Center, iNANO.

"It's obvious that the potential of nanomedicine is enormous and that new forms of treatment could be developed. There's a great need for research in this field, and the Lundbeck initiative is therefore extremely visionary and timely. Nanomedicine is a cornerstone in Aarhus University's research strategy, which is now provided with crucial funds," says Centre Director Allan Flyvbjerg.

The Lundbeck Foundation has supported the initiative, which aims to bring together leading international research in biomedicine and nanotechnology and thus create breakthroughs in the future treatment of disease.

About Nano Connect Scandinavia

UK's Babraham Institute to Build Bioincubator

The commercial arm of the UK's Babraham Institute will raze its "200 series" of small incubator buildings on its campus in the coming year, replacing them with a single, new roughly £4 million ($6.5 million) bioincubator intended to house up to 16 early-stage biomedical startups.

Babraham Bioscience Technologies Ltd. says construction of its planned 8,800-square-foot Maia Phase I bioincubator is set to start in January, with the new bioincubator available to tenants in September, 2010.

BBT now houses within its current incubator space about 30 tenant startups occupying spaces of 500 to 1,000 square feet at the 450-acre Babraham Research Campus, some 6 miles south of Cambridge. Tenants include the bioinformatics services and software company Eagle Genomics; and Population Genetics Technologies, or PopGen, created to commercialize technology invented by Nobel laureate Sydney Brenner for obtaining sequence information from thousands of genomes simultaneously.

"The space is available to any company that is a biomedical enterprise, so we would expect to get additional genomics and proteomic companies attracted to the site," said Derek Jones, CEO of Babraham Bioscience Technologies.

Babraham will use current staffers to run Maia Phase 1, "but may consider additional hires," he said.

Jones said the new space, as with current incubator space, will be open to startups whether spun out of the institute or from elsewhere. The institute's most recent spinout, Crescendo Biologics, said in October it had raised £4.5 million in seed funding from Paris-based Sofinnova Partners with Aitua, Avlar BioVentures, and the UK government-created £10 million Rainbow Seed Fund also participating.

"We are hoping to have an MRC spinout here too," he said, referring to the Medical Research Council Laboratory of Molecular Biology in Cambridge.

Maia Phase I will expand to about 70,000 square feet Babraham's total bioincubator space. That space, now 92 percent occupied, includes the 20,500-square-foot Minerva building, completed in 2006; the 20,000-square-foot Meditrina building which opened a year later; Building 405, which offers lab and office units as small as 324 square feet — and the "200" series, which Jones said will be demolished "in due course" to make way for Maia Phase I.

The newer buildings are all named for Roman goddesses: Maia was the goddess of growth and fertility; Minerva, wisdom; and Meditrina, medicine.

"We have space and planning consent for an additional building like Meditrina, Maia Phase 2, although at this stage we have no idea if and when Maia Phase 2 will be built," Jones said.

Selling points for Maia Phase 1, as with existing space, will include communal laboratory equipment and meeting areas; access to the institute's academic experts — and access to BBT's Technology Development Laboratory, a biology and chemistry laboratory designed for proof-of-concept stage users in molecular biology, protein biochemistry, cell biology, and medicinal and synthetic chemistry.

BBT welcomed its newest tenant on campus within the past month, and is in late stages of talks with a prospective tenant interested in moving to the campus at the end of January.

"We hope to have created a campus environment and culture rather than a research/science park environment," Jones said.

Roche Unveils Plans for New Main Office Building In Basel

Roche is unveiling the plans for Building 1, the new office building that the company intends to build at its Basel site. The project, which will accommodate some 1900 attractively designed workplaces, is the alternative to the “Twist 2 Spirals” scheme that the company decided not to continue a year ago. It meets all Roche’s requirements in terms of functionality and engineering.

Work in the year ahead will focus on official approval processes, and the aim will be to finalize the legal aspects of the development plan and obtain approval for the new building.

“Roche needs a new office building in Basel”, commented Roche CEO Severin Schwan. “We are convinced that having all the company’s departments – Research, Development, Production, Marketing and Corporate – close to each other will be crucial in ensuring that they work together successfully. That’s why we will be bringing the 1,800-plus employees who currently work in offices all over town back to the main site."

“The new building is a harmonious fit with the rest of our site and meets all our requirements in terms of functionality and engineering”, added Matthias M. Baltisberger, Head of Roche’s site in Basel. “The new office building will enable us to offer our employees attractive workplaces and a top-quality infrastructure.”

The new building continues the predominantly white color scheme that is typical of the Roche site and which has also been adopted for the research and development building currently being built on Basel’s Wettsteinallee. Both new buildings have been designed by Herzog and de Meuron and tie in with the architectural idiom defined by Otto Salvisberg. The new office building thus continues the longstanding tradition of high-quality industrial architecture that characterizes site development at Roche.

Details:

1900 workplaces
76’000 m2 (817,760 sq. ft.) floor space
Costs: approx. 550 million Swiss francs
Energy efficiency: Swiss Minergie standard
Earthquake-resistant construction

Timeline:

Official processes and demolition of old building: 2010/2011
Scheduled start on site: 2012
Scheduled completion: 2015

FDA Expands Presence Outside U.S.

As part of its continuing effort to buttress food and medical product safety in this country by working with its regulatory partners overseas; the U.S. Food and Drug Administration has announced the opening of its Mexico City post. This is the Agency’s third post in Latin America and its tenth international post in the past 13 months.

“The opening of this office represents an important step as we re-design our product safety strategy. We, like our partners in the Mexican Government, realize that prevention is the key. For example, more than a third of the fresh fruits and vegetables we eat come from Mexico as do a large amount of our medical devices. Having FDA experts located permanently there will be mutually beneficial to both our countries and respective citizens,” says U.S. FDA Commissioner Margaret Hamburg.

Staff assigned to the FDA’s Mexico City post will work with their counterparts in the Mexican government to harmonize regulations and guidance standards and to work on other collaborative initiatives. These collaborations will include, for example, information-sharing on the respective regulatory systems and joint workshops on the safety of food and medical products. Agencies in both governments also will make efforts to find opportunities for joint training on food-borne illnesses and the oversight of food traded internationally.

FDA staff also will offer collaboration on the use of the latest laboratory techniques, foster other collaborative initiatives to ensure the safety of food and medical products marketed in the two countries, and be a “portal” to the FDA for counterpart Mexican agencies and the US-export industry in Mexico.

“FDA staff will work with industry in Mexico as well,” says Murray Lumpkin, U.S. FDA Deputy Commissioner for International Programs. “FDA experts in Mexico City will work closely with local industries that ship food and medical products to the United States to improve their understanding of U.S. safety and product quality expectations. Their activities will include providing technical advice and working with government agencies and the private sector to develop certification programs.”

To date, the FDA has opened 10 international posts, including posts in China, India, Europe, and Latin America, along with its USA-based staff. The other posts in the Latin America Office are located in Santiago, Chile, and at the FDA’s Latin America Office headquarters in San José, Costa Rica.

Sanofi Boosts Syringe and Vaccine Capacity at French Plant

Sanofi Aventis has revamped operations at its sterile injectables plant in Le Trait, France, adding three new production units that double syringe making capacity and diversify its vaccine manufacturing capability.

The expansion is primarily designed to boost production of prefilled syringes for the low molecular-weight heparin product Lovenox, demand for which is growing at around 13 per cent a year according to the French major.

Speaking at the unveiling ceremony, Sanofi CEO Christopher Viehbacher, said: “Le Trait is one of many examples of Sanofi-aventis’ desire to invest in France in order to be able to meet worldwide public health challenges.”

Viehbacher explained that over 90 per cent of the million syringes made at the facility each day are exported, with around 25 per cent being shipped to the US.

The investment has also expanded the range of vaccine production and manufacturing operations Sanofi can undertake at the plant.

While the facility already makes the seasonal influenza vaccine Vaxigrip in collaboration with the firm’s Sanofi Pasteur unit, starting later this month will begin packaging an infant meningitis for the Japanese market.

Additionally, Sanofi will begin making its intradermal influenza vaccine Intanza early next year.

The €87m ($127m) expansion includes new filling, inspection and syringe packaging lines as well as innovative, “operator-free” isolation technology to prevent contamination during manufacturing operations.

The “operator-free” approach is borrowed from safety and containment principles employed in the nuclear industry which, according to Sanofi, are being applied in a number of sectors, citing French carmaker Renault as an example.

The firm also highlighted the addition of electron beam (e-beam) sterilization technology to the product filling lines installed at the facility, which it believes will offer a way of accelerating manufacture by reducing the time it takes to decontaminate components during the process.

Covance Sets Up in Seoul and Mumbai

US CRO Covance says its new development offices in South Korea and India will improve access to patients and reduce clinical development timelines.

The firm explained that the South Korean unit in the capital Seoul will act as a key support hub for its network of clinical research associates (CRA) across the Asia-Pacific region, with the new Mumbai office providing the same service in India.

Covance’s move into the Asia-Pacific market began nearly 20 years ago with offices in Australia and Singapore. More recently the contract research organization (CRO) established units in Shanghai and Beijing in China.

Nick Wright, general manager of Covance’s operations in the region, "Our new Asia-Pacific offices support our global expansion strategy, which targets the most qualified investigators and appropriate patient populations in a region that is increasingly important to clinical trials."

He went on to say that "These offices will help us increase our clients' Phase II/III clinical trial productivity by providing additional capacity to execute clinical studies with a full range of services."

The firm has also expanded existing units in Hong Kong and in Tokyo, Japan to try and capture a share of the region’s rapidly expanding clinical trials market.

The Tokyo facility will also offer additional central laboratory services, assay kit customization services as well as sales and administration support as a result of the expansion.

Company clinical development services president Rick Cimino explained that the new offices, which increase the number of countries in which the firm operates to 55, are part of a concerted customer support and growth strategy.

"To enable us to meet this commitment and provide more effective clinical trial solutions, we have significantly expanded our presence in emerging markets in 2009 by opening nine new offices in Asia Pacific, Latin America, and Eastern Europe."

Icon Triples Capacity at Dublin Lab

CRO Icon says the expansion of its central lab facility in Dublin, Ireland will provide better support for its clinical investigators worldwide.

The new facility, which at 3,800sqm (40,888 sq. ft.) is three times the size of Icon’s previous central laboratory, houses capacity for microbiology, molecular diagnostics, flow-cytrometry, endocrinology and radio immunoassays (RIA).

The contract research organization’s (CRO) laboratory also features four times as much sample handling capacity, which will provide a number of operational advantages according to CEO Peter Gray.

He suggested that: “The extra capacity in our Dublin laboratory enables Icon to extend our capabilities to support clients’ demands for more sophisticated testing.

“Icon Central Laboratories Dublin will continue to act as an important central hub for global trials and we look forward to delivering effective laboratory services to an even greater number of sponsors and investigators around the world.”

NextPharma Plans German Cold-Chain Logistics Facility

NextPharma unveiled plans for a new cold chain and logistics unit to bolster its European distribution operations.

The facility, located in Werne, western Germany, will house some 15,800sqm (170,000 sq. ft.) of warehouse space, sufficient for up to 19,000 pallets, when fully operational in August next year.

CEO Bill Wedlake, CEO NextPharma agreed and said that the emergence of the high-tech drug market was a key driver for development of the new facility.

“We are aware that more and more products in the Pharmaceutical and Biotech industry require special handling and storage and we are excited at the prospect of being able to meet our customers’ requirements to an even higher standard through this state of the art facility.”

To this end the Werne site, which will employ a staff of 40 people, will have under floor heating, hot-air blowers and air conditioning to ensure drugs are kept at the appropriate temperature prior to distribution.

NextPharma added that it will seek both wholesaler authorization and a manufacturing license for manual re-packaging, bundling and labeling of secondary packaging for pharmaceutical products.

Werene is situated between Munster and Dortmund, near the region’s major motorway, the A1, which makes it “a fantastic new addition to the NextPharma CLS network," according to company managing director Jost Bunse.

Specifically, the town is easy to access from NextPharma’s existing cold-chain distribution centers in Waltrop and Bielefeld.

The new facility, in addition to the two existing German units and other in Stockerau, Austria and Turbenthal, Switzerland, provides NextPharma with a significant European cold-chain storage and distribution reach.

Dishman Partners with Saudi API

Dishman Pharma says its new Saudi Arabian joint venture (JV) will establish the first API production plant in the Middle East.

The Indian contract manufacturing organization (CMO) has a 30 per cent share in the new

business, with the remainder of the firm being split between formulation firm Spimaco, ACDMA and the Capital Advisory Group.

The unit, which is scheduled to be up and running in just over a year’s time, will operate from a purpose-built active pharmaceutical ingredient (API) making facility that is currently being built just outside the Saudi capital Riyadh.

Dishman spokesman Henk Pluim said: “The detailed engineering of the API production facility will be completed by end of January and construction of that facility will start early March.”

Pluim explained that although the Middle Eastern market will be the initiation focus, “The facility will be fully cGMP compliant [so] it also offers in the second phase access for certain APIs to customers in the rest of the world.

“Currently the Saudi Arabian and Middle East markets … are fully served from abroad and, for Dishman, [are currently] of minor importance and therefore this [JV} offers for us a nice growth potential in this region.”

According to a report in the Business Standard the Saudi Industrial Development Fund has offered a $55m (€38m) 15-year loan to support the project.

The Riyadh plant is not the only one in which Dishman is investing at the moment. In November the firm opened HPAPI and vitamin D analogue high containment cGMP laboratory in the Netherlands.

Dishman is also spending INR1.5bn (€22.2m) to expand its contract manufacturing facility in Bavla, India and plans to invest a up to INR6bn in four facilities in special economic zones (SEZ) in the country over the next five years.

And finally, Dishman’s Arabian wing has entered into a second JV in Saudi Arabia, this time partnering with Takamul to set up a disinfectant making facility.

Hospira Acquires Orchid's Generic Injectables Unit

Hospira will acquire the generic injectable finished-dosage form pharmaceuticals business of Orchid Chemicals & Pharmaceuticals for approximately $400 million.

The acquisition includes Orchid's beta-lactam antibiotics manufacturing complex (comprising cephalosporin, penicillin and carbapenem facilities) and R&D facility at Irungattukottai, Chennai, as well as its generic injectable product portfolio and pipeline. Beta-lactam antibiotics represent a class of drugs with a wide spectrum of antibacterial activity.

In addition, the companies signed a long-term exclusive agreement for Orchid to supply APIs for the acquired generic injectable pharmaceuticals business. This agreement builds on the existing product development and commercialization relationship between Hospira and Orchid.

According to a Hospira statement, the move provides several benefits:

Hospira acquires a proven-quality, cost-competitive generic injectables manufacturing site that has approvals from international regulatory authorities, including the FDA, as well as an R&D facility and a talented base of approximately 450 employees dedicated to the development and production of beta-lactam antibiotics.

The move secures full ownership of Hospira's primary beta-lactam portfolio and pipeline that were previously part of a commercialization agreement with Orchid.

Hospira can establish a direct presence in India, providing a platform for future commercial growth.

"This acquisition aligns perfectly with Hospira's strategy to improve our margins and cash flow, by lowering our cost position for a key product line, and to invest for growth, by expanding our presence globally and reinforcing our leadership position in generic injectables," said Terry Kearney, chief operating officer, Hospira. "Orchid's quality, speed to market and productivity are hallmarks of its business. We look forward to welcoming our new colleagues from Orchid and leveraging their collective knowledge to meet the evolving needs of Hospira's customers."

"This transaction and the long-term API contract are a testimony to the competitiveness of Orchid's product portfolio in the global pharmaceuticals landscape, and its established capabilities in aseptic product manufacture. We are confident that Hospira will take our generic injectable pharmaceuticals business to even greater heights and provide enhanced career prospects to the employees being transferred. This transaction will provide Orchid with the financial flexibility to pursue new growth opportunities, and build upon our successful track record of value creation for our shareholders," said K. Raghavendra Rao, managing director, Orchid.

In 2005, Mayne Pharma Ltd. (now part of Hospira) and Orchid entered into a strategic commercialization and development agreement. Subsequent agreements have added to the scope of the relationship. The acquisition is expected to be completed in 1Q10. To help facilitate the transition process, the two companies will enter into transitional services agreements for approximately 12 months.

Recipharm Announces its Intention to Acquire Cobra Biomanufacturing

Recipharm AB, a contract pharmaceutical development and manufacturing organization (CDMO), has announces its intention to acquire Cobra Biomanufacturing plc, a UK-based, cGMP compliant contract manufacturer of biopharmaceuticals.

This move will considerably broaden Recipharm’s biologics offering whilst providing access to new markets and technologies including the production of proteins, viruses, DNA and cells for use in pre-clinical through to Phase II clinical trials.

With facilities located in Oxford and Keele (UK), Cobra Biomanufacturing is an established provider of DNA for gene therapy. The company has the capability to utilize the MaxXpress maximum protein expression system, harnessing the power of UCOE technology, to deliver high productivity cell lines and strains and reduced manufacturing costs for its clients. Cobra has also established a significant I.P. portfolio around its own oral vaccine technology, ORT-VAC, based on their patented high plasmid maintenance technology. The ORT-VAC technology has the potential to deliver a wide range of vaccines that would be taken orally.

The acquisition of Cobra Biomanufacturing will form an integral part of Recipharm’s strategic goal to increase its footprint in biologics and offer higher volumes of GMP production together with a wider range of services. The move is set to more than double the size of Recipharm’s biologics business

Long-term, Recipharm plans to provide a full suite of ‘one-stop shop’ biologics capabilities, expanding on its current biomanufacturing services and its ability to fill and finish active pharmaceutical ingredients.

Recipharm intends to both retain Cobra Biomanufacturing’s existing expertise and will actively recruit additional personnel to bolster its newly combined biologics business.

Commenting on the news, Thomas Eldered, CEO and managing director of Recipharm, said, “Our intended acquisition of Cobra Biomanufacturing is yet another example of our stated goal to develop world-class development and manufacturing solutions for the biopharmaceutical industry. This operation will run alongside our existing biologics facility in Sweden and complements very well our established capabilities in small molecules. This I believe creates a very strong offering, enabling us to further develop our customer base amongst both emerging biotechnology and large pharmaceutical companies.”

Commenting on the acquisition, Simon Saxby, CEO of Cobra, said, “The acquisition by Recipharm of Cobra is a welcome and essential step in order for Cobra to be able to provide the long term stability and increased scale needed for our clients. In a combined organization with Recipharm we will be able to compete very strongly and more effectively in the global biomanufacturing market”.

Alcan Packaging Plant Targets Emerging Markets

Alcan Packaging has started production trials at a new flexible packaging plant in the Czech Republic as part of its strategy to strengthen its position in the growth markets of Central and Eastern Europe.

“We are already very strong in Western Europe and see expansion in Eastern Europe as a key to broaden our markets”, said an Alcan spokeswoman.

The France-based company, which is a subsidiary of Rio Tinto, announced the €17m facility in Novy Bydzov will focus mainly on the production and printing of high quality rotogravure flexible packing.

The factory, the company’s fourth in Eastern Europe, will employ 100 workers when it reaches full production capacity, has been earmarked to supply emerging food markets in Central and Eastern Europe as well as the Germanic and Nordic regions.

The announcement on the plant, which is scheduled to reach full production by the end of January 2010, comes just days before the European Commission is due to gives its decision over the proposed takeover by Australian company Amcor.

“For now we continue to work business as usual for Alcan Packaging and we remain a competitor of Amcor until a final decision is made," added the company spokeswoman.

Michael Cronin, president, Alcan Packaging Food Europe, said: “This state-of-the-art facility is another important step in our strategy to follow our customers to the growth markets of Central and Eastern Europe.”

The packaging chief highlighted the swift pace of the company’s project planning and execution, saying the initiative had gone from decision to start up in 17 months.

“[It] clearly demonstrates our ability to respond rapidly to our customers' demands and requirements,” Cronin added.

Alcan Packaging Food Europe, a leading flexible packaging player in Europe, operates 31 plants in 18 countries. The business is expected to be sold off as part of the $2.025bn takeover by Amcor. In a recent statement, company managing director Ken MacKenzie said the business would “complement Amcor’s existing operations in higher growth regions”.

Amcor said it would be willing to sell off one of its own flexible packaging units to address European Union anti-trust fears over its proposed takeover of Alcan. The announcement came after the Commission said it would push back its review of the deal by two weeks from 30 November to 14 December.

Patheon to Consolidate Manufacturing Operations in Puerto Rico

Patheon, a global provider of drug development and manufacturing services to the international pharmaceutical industry announced its plan to consolidate its Puerto Rico operations into its manufacturing site located in Manati, and ultimately close or sell its plant in Caguas.

Commenting on the decision, Wes Wheeler, Chief Executive Officer and President of Patheon Inc., said, "We remain committed to growing our contract manufacturing business in Puerto Rico. We believe our customers continue to need a high quality and reliable supplier on the island. However, we have decided that it is not practical to operate two plants within close proximity of each other. We will consolidate our people, resources and investments at Manati and therefore concentrate on growing one 'flagship' site. We will work carefully with our customers, employees and authorities in Puerto Rico to affect a smooth and seamless transfer of existing products."

"We are keenly aware that the closure of Caguas may impact many of our employees and their families. With this in mind, we are developing plans to offer affected Caguas employees available positions at our Manati site. For those employees who are not able to be accommodated in Manati, we will work to assist them in the transition," added Wheeler.

"It is my biggest desire to be able to join municipal efforts to those of Patheon's to drive economic growth in our city," said Juan A. Cruz Manzano, Mayor of Manati, Puerto Rico. "We will continue to work in support of the valued employers in our area."

Luis Fortuno, Governor of Puerto Rico added, "We appreciate Patheon's contribution to the continued economic growth of the northern most region of the island, as well as its efforts to maintain its operations as the sole provider in Puerto Rico of contract development and manufacturing services to the global pharmaceutical industry."

The company estimates this consolidation will result in total repositioning expenses of approximately $7.0 million, of which approximately $2.4 million will be booked in the first quarter of fiscal 2010. Patheon also expects to book an impairment charge of approximately $1.3 million in the first quarter of fiscal 2010 in connection with the consolidation plan. The consolidation will be completed by the end of fiscal 2011, and will also result in accelerated depreciation of Caguas assets of approximately $7.0 million during the 2010-2011 fiscal year period.

University of Leeds Pioneering New Methods of Drug Manufacture

Engineers at the University of Leeds have developed a simple technology which can be used in existing chemical reactors to ensure "right first time" drug crystal formation.

Ensuring drug crystals are formed correctly is crucial to their efficacy and the efficiency of pharmaceutical manufacturers' operations. Using self-assembled monolayers, the team has been able to show that crystals form into their desired product form with the correct shape and particle structure, without the usual problems of polymorphism which results in huge losses to the pharmaceutical sector each year.

"If you imagine the way that oil sits on top of water, that's similar to how the monolayer works," says Professor Kevin Roberts of University's Faculty of Engineering. "We've shown that we can produce a well-defined crystal structure using a self-assembled monolayer bound onto a metal substrate within a regular reactor. This is exciting stuff, because it's a relatively simple system, but could make a huge difference in the efficiency of drug manufacture."

One of the first stages of the crystallization process is called nucleation. During nucleation, particles are introduced into a reactor to encourage the formation of crystals. However, the way in which this is currently carried out is difficult to control and can often lead to the wrong shape, size or structure of drug crystal, something which affects the usefulness and efficacy of the compound.

The new system proven to work by the Leeds team, working alongside Ana Kwokal from Croatian pharmaceutical company PLIVA, has shown that introducing a self-assembled monolayer - a layer of self-organizing molecules that is attractive to the substance being crystallized - into a reactor enables consistent crystal formation.

Professor Roberts says: "Because this is a really simple solution to ensuring consistent crystallization, it has huge potential commercially. Our next steps are to make sure it's just as efficient on an industrial scale."

This work draws on previous research and experimental systems developed through the Chemicals Behaving Badly II initiative, an Engineering and Physical Sciences Research Council (EPSRC) program which includes universities and industrial partners.

The 2008 Research Assessment Exercise showed the University of Leeds to be the UK's eighth biggest research powerhouse. The University is one of the largest higher education institutions in the UK and a member of the Russell Group of research-intensive universities. The University's vision is to secure a place among the world's top 50 by 2015.

Dynavax Hep-B Vax Site Approved

Dynavax Technologies' GMP manufacturing facility in Duesseldorf, Germany has been approved for the commercial production of hepatitis B surface antigen, a key component of HEPLISAV, the company's investigational adult hepatitis B vaccine. The approval comes as a result of an upgrade, expanding production capacity. With an updated EU GMP manufacturing license in place, Dynavax can meet the initial commercial production demands for the anticipated launch of HEPLISAV, according to a company statement.

Dynavax's German subsidiary Rhein Biotech has manufactured the hepatitis B surface antigen for HEPLISAV clinical trials in this facility since 2006. The facility upgrade also enhances integrated product development and manufacturing services Rhein Biotech provides to third party partners.

Telangana Plans Disrupt GSK and Eisai in India

GSK halted production in Rajahmundry and Eisai postponed the opening of a new manufacturing facility in Vizag after protests over Indian government plans to create a new state, Telangana, within Andhra Pradesh.

GlaxoSmithKline (GSK), which has now resumed production and Eisai took the action after days of unrest about the controversial proposal.

The Telangana plan, which has been discussed for many years, was passed by the Indian government on December 9 becoming a “mere formality” according to Home Affairs Minister P Chidambaram.

However, while the subsequent resignation of local legislators and members of parliament, as well as ongoing public protests may still mean the decision is reversed, the furor it has created is already impacting the region’s drug manufacturing sector.

M Narayana Reddy, former president of the country’s Bulk Drug Manufacturers Association (BDMA), stressed this point in an interview with the Press Trust of India (PTI) on December 12.

Reddy told the PTI that, across the region as a whole, the production of drugs, active pharmaceutical ingredients (APIs) and intermediates worth around INR4bn (€58m) worth had been interrupted.

He also suggested that these stoppages will continue to have an impact for some time because drug and API manufacturing rely on many continuous processes that will take time to restart.

Aside from the manufacturing stoppages, uncertainty about the region’s future, particularly its approach to the taxation, may have an impact on national and international investment, which is an idea also touched upon by Reddy.

He argued that because “business runs on trust. Even a slightest doubt, in their minds, may create a blockade for investments in the State.”

Others, however, were less downbeat about the likely impact the creation of Telengna will have on local drug manufacturing industry.

Pennar Industries’ chairman, Nrupender Rao, told the Economic Times that key pharma players based in the region such as Dr Reddy’s, Aurobindo and Shantha Biotech are unlikely to move in the short-term.

Rao argued that: “Other industries, largely those in the manufacturing sector, have offices in many parts of the country. Therefore, the creation of a separate state wouldn’t likely have much of an impact.”

London's Biomedical Research Institute Takes Shape

Tight budgets could mean operations begin with fewer researchers.

Plans for the UK Centre for Medical Research and Innovation are crystallizing. Details of a new £520-million (US$850-million) biomedical research centre in central London were revealed, giving some insight into its proposed scientific scope and architecture.

The UK Centre for Medical Research and Innovation (UKCMRI) will bring together four leading UK research institutes in one building on a 1.5-hectare site near London's St Pancras International rail station. The centre will accommodate the Medical Research Council's National Institute for Medical Research (NIMR), currently based in Mill Hill, just outside London, and Cancer Research UK's London Research Institute, which has laboratories split over two sites — one in central London and the other near Potters Bar in Hertfordshire. Also partners in the project are University College London and the biomedical-research charity, the Wellcome Trust.

Biologist and Nobel laureate Paul Nurse, president of the Rockefeller University in New York, is leading the scientific planning for the UKCMRI. He told journalists today that the centre will aim to be a "magnet" for attracting and training the best young researchers from all over the world, with the hope that they will then move to other UK institutions. "UKCMRI will be a feeder for other research institutes in the UK," Nurse said.

The institute will have "no particular" research focus but will aim to cover all aspects of human disease by building on the science expertise of its partner organizations, including fields such as infectious disease and brain cancer. However, he proposed that research areas could, for example, include the use of stem cells to grow human organs in the lab. University College London will contribute research in non-biomedical areas including computer science, engineering and physics.

Animal research will be carried out at the institute, but pathogens, such as the Ebola virus, that require the highest level of biological containment, category 4, will not take place. It is not clear what will happen to the category 4 research that is currently undertaken at the NIMR. A more detailed science plan will be developed over the next few years, Nurse said.

Clinical research will not be done in house — instead, UKCMRI scientists will collaborate with nearby hospitals and research centers. Translating that research into products and services will be something that is embedded in the institute's culture, rather than being an afterthought when research projects come to an end. But the building will not house biotech companies — one proposal that had previously been floated for the centre.

The centre will be an open-plan environment without "artificial departments", and will have communal break-out areas to encourage collaboration and discussion between the institute's researchers. It will also have networking and training centers that can be used by external researchers. Much of the front of the building will be glass, letting the public see researchers at work in their labs.

The building was originally estimated to cost £500 million, but the need to build an extra basement floor has added to costs. Nurse said that a definite figure for the building costs would not be available until the construction contract goes out to tender, but noted that the budget "will be tight".

The Medical Research Council will pay for 45–50% of the building costs, while 25–30% will come from Cancer Research UK, 20% from the Wellcome Trust and 5–10% from University College London.

Nurse said that if construction goes over budget they will seek to find savings, which may include starting operations with fewer than the intended 1,250 researchers, and building up their numbers over time.

He also added that no concrete plans are in place for how to choose which researchers at the partner institutes will move to the UKCMRI, but that staff will undergo a review and assessment to help inform the decision.

Nurse noted that he was not concerned for the institute's future if the current Labour government loses power to the Conservative party at a general election due to be held next year. He said that the Conservatives had shown "support" for the project in informal discussions.

Planning permission for the building is expected to be submitted to the local council next year.

IFF Targets Russian Tastes with New Moscow Facility

International Flavors and Fragrances cut the ribbon on a new facility in Moscow, which will help it get closer to its customers and understand tastes in the high-potential Russian market.

IFF, one of the world’s top three flavor firms, has been represented in Russia by agents since the early 1990s. In late 2007 it decided to set up its own operations, as Russia is recognized as a major emerging market with much potential for future business.

Hernan Vaisman, group president for flavors at IFF, said that the company strategy is to put more resource into all emerging markets. This year new creative centers have opened in Sao Paolo, Russia, and Shanghai, China.

The aim is to be amongst the leaders in the Greater Russia flavor sector – and that means having a stronger presence in the area.

“It makes a huge difference if you are working remotely or if you have people on the ground,” said Helga Moelschl, regional sales director for Russia, Ukraine, Belarus, and Central Asia.

Vaisman did not disclose the proportion of IFF’s sales that currently stem from Russia or from emerging markets overall, but between 70 and 75 per cent of the company’s sales are outside the United States.

The new facility, in the Moscow City business district, occupies a 460-square-metre building. It includes a test kitchen, application kitchens and a laboratory – as well as space for sensory and consumer insight analysis, and offices.

IFF has been recruiting local employees for the last 12 months, who will help bring greater understanding of tastes in the region. Since IFF has a global organization, the team in Moscow will be supported by expertise at other sites in France, The Netherlands and the UK.

Karen Crofts-Hotston, VP regional general manager EAME flavors, said:

"While we are very proud of this facility, the best tools and equipment are meaningless without passionate people with energy, expertise, creativity and drive. I am proud to say that we have some of the best talent working here with one goal in mind: To create the very best flavors and fragrances for our customers."

Russia is considered a market of high potential for the food industry as rising incomes are having an effect on eating habits.

“The population is very sophisticated and young, and people are catching trends coming from the West,” said Vaisman. The major trends in Russia are the same as those seen in other parts of the world, but with local taste twists.

In snacks and culinary flavors, for example, a very typical taste is dill; in beverages, tomato juice has a huge consumer following; and in confectionery the flavor profile of condensed milk is popular.

On the other hand, people are very curious to taste new things and are keen to try ethnic foods.

Touran Cheraghi-Kroon, director C&A, innovation EAME, said that preference profiles do differ across Greater Russia in subtle ways. One important driver in Belarus and Central Asia she pointed out is a need for cost-cutting. “That is more relevant than in Moscow.”

One of the big challenges to going business in Russia is geography, said Vaisman. “It’s a big country, and the plan is to cover all territories in the years to come.”

He explained that every company on the ground is facing the same challenge – how to bring your goods to a customer that may be very far away. IFF will be working hard to secure its distribution network, so it can be sure that even if a consignment must travel far, it will still embody the company’s standards, vision and mission on arrival.

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