Azopharma Product Development Group, Inc. has announced the addition of Microdosing and Central Lab services to its clinical pharmacology research facility, AvivoClin Clinical Services, located in Daytona Beach, Florida. This extension of services compliments AvivoClin's current offerings of Phase I-III studies and is accommodated by the recent facility expansion.

Microdosing is an important trend among pharmaceutical and regulatory agencies around the world which provides early pharmacokinetic and pharmcodynamic data in humans. AvivoClin is now able to offer Phase 0 Microdosing solutions to clients which include synthesis and labeling of material, formulation, administration of microdoses in a clinical environment and analysis of samples.

Along with Microdosing, AvivoClin will also offer central lab services. By bringing the laboratory testing in house, clients will experience a quicker turn-around time for results, a decrease in errors and a reduction in costs. According to Phil Meeks, Chief Executive Office of Azopharma, “The increased space and capabilities allow us to better serve the growing needs of our clients. Through AvivoClin, Azopharma Product Development Group can support numerous clinical studies simultaneously resulting in higher level of service.

Harmony Completes New Facility in North Carolina

Harmony Labs, Inc. has completed construction and validation of its new 135,000-sq.-ft., state-of-the-art R&D and manufacturing facility. The new facility will house the company's research and analytical chemist team, as well as serve as the central location for the manufacturing of pharmaceutical, OTC, and cosmetic liquids and semi-solids.

“This is a significant milestone in our history and one that signifies Harmony Labs’ continued commitment to being the leading expert in skin care development and manufacturing,” said Will Lynch, chief executive officer and president of Harmony Labs.

With this new facility, the company now occupies more than 200,000 sq. ft. of operations. Services include on-site formulation, development, analytical work including micro testing, and ICH stability, and validation programs for OTC and Rx products.

Biological E’s New Vaccine Campus Inaugurated

Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus.

The 75 acre site, which is located just outside Hyderabad, is being developed in partnership with the Indian government to make products for both the domestic and international markets, including Europe and the US.

Hyderabased-headquartered vaccine maker Biological E, which will run the facility to produce a range of vaccines and biologics for diseases including tetanus, Hepatitis B (HBV), Haemophilus influenza Type B (Hib), and a diphtheria-tetanus-pertussis combination vaccine.

The firm said that it plans to invest a further INR2.5bn in the site over the next few years to “[expand] capacities and [create] infrastructure for the future pipeline products of the company”.

The most advanced product in Biological E’s pipeline is a novel vaccine for Japanese encephalitis, which the firm says it may also produce in Hyderabad if it is approved by the country’s drug regulators.

Earlier this month, government plans to re-open three state owned vaccine markers that it closed in 2007 to cope with a shortfall in its immunization program were heavily criticized.

The firms in question, BCG Lab, the Pasteur Institute of India (PII) and the Central Research Institute (CRI) were shut down after they failed to meet good manufacturing practice (GMP) standards for vaccine production.

At the time the government said it planned to convert the businesses to testing facilities and replace the lost manufacturing capacity with that from Hydreabad and a similar public-private co-funded campus being constructed in Chennai.

For the past year however, the government has sought to compensate by increasing the amount of vaccines it buys from private suppliers both in India and overseas. Despite these efforts, there have been problems sourcing sufficient doses for state vaccination programs.

Last month Union Health and Family Welfare Minister Anbumani Ramadoss told the Indian parliament that a shortage of vaccines affected the Universal Immunization Program “in some states.”

Torrey Pines Hits Biotech Finish Line First

Torrey Pines' 100,000-square-foot building in Port St. Lucie has attracted additional research and development projects.

As the Torrey Pines Institute for Molecular Studies celebrates the opening of its $40 million, 100,000-square-foot Port St. Lucie campus, other institutes are devising plans to join it at the so-called Florida Center for Innovation at Tradition.

Though it came to the Florida biotech game three years after The Scripps Research Institute agreed to open a giant lab in Jupiter, Torrey Pines is opening its campus a month before Scripps. It's also upstaging The Burnham Institute for Medical Research in Orlando, which is scheduled to open in April.

The timing is no accident. Motivated by its underdog status, Port St. Lucie fast-tracked the Torrey Pines building to make sure the city's position in the state's biotech pantheon didn't go unnoticed.

Now, others are following Torrey Pines to the 150-acre research par. Including:

VGTI Florida, an extension of Oregon Health and Science University's Vaccine and Gene Therapy Institute is getting $60 million in state incentives to open an outpost in Port St. Lucie. Core Communities LLC, the park's developer, expects to break ground on VGTI's 105,000-square-foot building later this year. VGTI Florida announced that a prominent HIV-vaccine researcher will move his team of about 36 scientists from Montreal to Port St. Lucie. Starting in March, they will work from Torrey Pines while their building is under construction.

Mann Research Center is about 400,000 square feet of laboratory and office space proposed by a venture of billionaire medical-device entrepreneur, Alfred E. Mann. About 60,000 square feet is slated for the first phase, though no construction start date has been set. Mann Research Center LLC bought the 22-acre parcel in early 2008 and is recruiting companies to move in.

Martin Memorial Health Systems. The Stuart-based health-care provider hopes to build a hospital on 20 acres at the park. It would have 80 beds to start.

Meanwhile, a New York developer is finishing a 111-room Homewood Suites hotel, and Core Communities hopes to lure a conference center and second hotel next door.

All of the deals have been struck since Torrey Pines announced in September 2006 it would move its headquarters to Port St. Lucie, choosing the city over flashier contenders including Boca Raton. Core envisions that the Florida Center for Innovation will be home to about 1.6 million square feet of research and development.

For now, Torrey Pines' building stands alone on the plot of former farmland.

It houses chemistry and biology laboratories, plus an auditorium where workers can video-conference with scientists across the country. Its atrium is dotted with leather chairs and sofas, and institute President Richard Houghten foresees scientists exchanging ideas.

"It's really as much or more than we expected," Houghten said last week, sitting in his lake-view conference room at the new building.

Torrey Pines' 30 employees started moving into the lab this month, hauling equipment from their temporary home at Harbor Branch Oceanographic Institution north of Fort Pierce. By midsummer, another 10 are expected to join them.

Like Scripps Florida and Burnham, Torrey Pines received big incentives to join Florida's fledgling biotech industry. In exchange for the $100 million in state and local perks Torrey Pines got, it must employ at least 189 mostly high-paid workers within 10 years.

The infusion means Torrey Pines can focus on "edgy" research that wouldn't get funded through traditional grants, Houghten said.

A prime example: Its scientists are developing potential pain drugs that would be far more powerful than morphine, without the addictive properties.

"We want to try new things here. I don't think the state of Florida brought us here just to try the same-old, same-old," Houghten said.

Family Health Centers of San Diego Completed

Work on the North Park Pediatric Clinic and Development Center in Hillcrest, a Family Health Centers of San Diego medical office building, was completed, according to Ware Malcomb’s local office.

Ware Malcomb was the project architect for the 7,600-square-foot medical building. The two-story facility includes general medical offices, a pediatric clinic, and group classroom space.

Frakes Construction of San Diego was the general contractor. Construction costs topped $2 million.

The center, on 30th Street near Myrtle Avenue, was developed to alleviate patient overflow from the existing North Park Family Health Center adjacent to the new facility.

The Family Health Centers of San Diego is a private nonprofit community clinic organization.

Burnham Chemical Genomics Center Lands $10 Million Gift

The Burnham Institute for Medical Research has received a $10 million gift for its Center for Chemical Genomics from San Diego real estate developer Conrad Prebys, Burnham said.

The genomics center, which houses multidisciplinary studies focused on drug discovery technologies, will adopt the philanthropist's name and will be called the Conrad Prebys Center for Chemical Genomics.

The center is headquartered in La Jolla, Calif., but it plans to open another facility in Orlando, Fla. this spring. When both facilities are fully operational, the CPCCG will be capable of screening over two million chemical compounds per day.

Burnham President and CEO John Reed said in a statement that the donation will "enable us to advance discoveries farther and faster."

Burnham won a grant of around $100 million from the National Institutes of Health last September to establish a center of the Molecular Libraries Production Centers Network

American Peptide Company Announces Expansion of Its GMP Manufacturing Facility

American Peptide Company, Inc. announced the expansion of its state-of-the-art GMP peptide manufacturing facility in Vista, California. The facility expansion will increase the company’s large-scale peptide production capacity as well as enable it to continue to provide high quality peptides to its growing base of pharmaceutical and biotech customers.

This two-phase expansion encompasses the construction of peptide purification and peptide synthesis suites. Four additional purification suites will be completed in the first phase and commence operation in April 2009. This addition will include new HPLC columns and tray lyophilizers.

The second phase of the construction includes two additional large-scale synthesis suites for both solution and solid phase, and completion is forecasted for Q2 in 2009. A unique component of this expansion are the 1,000 L to 2,000 L reactors for solution phase synthesis, in addition to the 260 L to 500 L SPPS for solid phase synthesis. Storage capacity will be doubled, and a 200 L tray lyophilizer will be installed to accommodate large scale production.

"As American Peptide Company continues to grow, we are investing in our production capacity to account for a larger customer base and bulk orders,” says Takahiro Ogata, president and COO, American Peptide Company. “This facility expansion is yet another initiative we have implemented to meet our customers’ specific needs in the drug development and manufacturing process.”

Earlier last year, American Peptide Company introduced its Total Peptide Management Program, a customized service platform designed to help pharmaceutical and life sciences industries bring new and innovative drugs to market faster. The program offers a broad portfolio of peptides, value-added services, and expert consultation to support customer needs as drug products move from discovery to development and commercialization.

Novavax Announces Operational Status of Its Vaccine Pilot Plant and Commercial Launch Facility

Novavax, Inc. announced that all equipment in its new Good Manufacturing Practice ("GMP") Pilot Plant to manufacture pandemic and seasonal influenza vaccine clinical supplies and commercial batches at a 1,000 liter scale are installed and ready for operations supporting scale-up and validation. The project was initiated in December 2007. The facility demolition, construction and initial qualification were completed in 120 days and were announced with a ribbon cutting in May 2008. The original design by Jacobs Engineering (Conshohocken, PA), which included multiple Wave bioreactors for production of VLPs, has been modified to include stirred reactors based on the potential for enhanced production yield. The stirred reactors, which utilize disposable liners in keeping with the desire to maintain a disposable manufacturing process, were received September 2008 and are now installed in the facility.

The facility is expected to be capable of producing 2-3 million doses of monovalent pandemic influenza vaccine per week at 15 mcg HA/dose (50 - 75 M doses in 6 months) once scale-up and validation are complete. Likewise, the facility can support up to 20 - 25 million doses of trivalent influenza vaccine in six months. The facility is GMP compliant and includes a total of 10,000 square feet of production and support space. The facility also includes media and reagent preparation space and equipment for production of vaccine for clinical trials. Large-scale commercial production, media, reagent and filling of bulk vaccines are planned to be outsourced. The total cost of the project, including demolition, construction, and installation of laboratory and production equipment, was approximately $5 million. The facility had existing mechanical systems in place (pharmaceutical air and water system) that were not included in the project cost.

This facility serves as a prototype for regional 'in-border' pandemic influenza production facilities which are offered to governments who want to ensure a rapid supply of pandemic influenza vaccine for their country. To keep the facility in a state of operational readiness for pandemic influenza production, seasonal influenza vaccine and other future VLP-based vaccines from Novavax may also be prepared.

The next steps for the facility include scale-up and validation of the process at full 1000L commercial scale, production of consistency lots for influenza vaccines, and regulatory review of the manufacturing and validation data once phase 3 clinical results are complete.

"The facility demonstrates the low capital cost of manufacturing with single use systems," said Jim Robinson, Vice President of Technical and Quality Operations. "Other manufacturers are spending hundreds of millions of dollars to build similar capacity. The high cost of typical vaccine manufacturing makes it difficult for a country to afford self-reliance for pandemic flu vaccine supply. Novavax can make a difference in protecting populations through our innovative manufacturing approach and our collaboration with GE Healthcare."

"This $5 million investment is the last significant capital expenditure required for manufacturing until after product launch," said Rahul Singhvi, CEO. "It supports our development pipeline and initial commercial needs. The facility can be expanded with additional bioreactors for additional capacity if needed."

APC Expands Peptide Production Capacity

American Peptide Company (APC) is expanding its manufacturing facility in Vista, California to meet growing demand for high quality peptides.

The expansion is taking place in two phases, the first of which should be finished in April. When complete the work will increase the company’s large-scale production capacity.

APC’s good manufacturing practice (GMP) compliant facility in Vista is already producing peptides but the addition of 2,000 L reactors for solution phase synthesis will help cater for clients’ demands for large orders.

Takahiro Ogata, president and chief operating officer at APC, said: "As American Peptide Company continues to grow, we are investing in our production capacity to account for a larger customer base and bulk orders.

“This facility expansion is yet another initiative we have implemented to meet our customers’ specific needs in the drug development and manufacturing process.”

APC is installing 1,000L reactors for solution phase synthesis in addition to the 2,000 L models. The company is also adding solid-phase peptide synthesis (SPPS) reactors ranging from 260 L to 500 L.

Large-scale production capacity will be further improved by doubling storage capacity and the addition of a 200 L tray lyophiliser.

These form part of the expansion’s second phase, which is due to be completed in the second quarter. The initial phase includes the installation of high performance liquid chromatography (HPLC) columns and tray lyophilisers.

FDA Forces Actavis to Shut Down Plants

Generic drugmaker Actavis has agreed to shut down several plants in New Jersey until they meet U.S. quality standards for the testing and manufacturing of pharmaceuticals.

The Food and Drug Administration said Friday it has filed a consent decree which will bar Actavis Totowa from making or distributing drugs from its plants in Totowa and Little Falls, N.J.

Under the agreement, executives Sigurdur Olafsson and Douglas Boothe will be able to resume production only after FDA confirms the plants meet U.S. regulatory standards.

The agreement also allows FDA to shut down the plants again if violations continue, and to fine the company $15,000 per day thereafter, up to $7 million per year.

FDA said it filed the action against Actavis Dec. 23 in U.S. District Court of New Jersey, and is awaiting a permanent injunction against the company.

Actavis Inc. and Actavis Totowa LLC are units of Iceland-based Actavis Group.

In April, Actavis recalled its generic heart drug Digitek because some tablets may have been twice as thick as they were supposed to be, which would have doubled the dose and created a greater risk of side effects.

In inspections last spring, the FDA found the company kept incomplete lab records of its testing data, and failed to verify that its testing methods matched up with actual conditions under which the products would be used. The company also made drugs at the Little Falls facility that had not been approved by the FDA.

"The FDA will not allow manufacturers to put the public's health at risk," FDA drug center chief Janet Woodcock said in a statement. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."

The federal Department of Justice filed its initial lawsuit against the company in November.

Pfizer cuts Work Force in Company Downturn

Pfizer’s fourth quarter results saw net income plummet by 90 per cent and revealed that the company is to close five manufacturing facilities, laying-off 10 per cent of its workforce.

The fall in profits was largely caused by a spike in costs relating to restructuring and legal matters. However, the company is continuing its cost-reduction drive, laying-off staff in sales, R&D and manufacturing and reducing the company’s facility square footage by 15 per cent.

In addition Pfizer is to reduce the number of manufacturing facilities it operates from 46 to 41. Pfizer has not revealed which facilities it will be closing, with the company assessing areas of overlap with newly acquired Wyeth before making a decision.

These restructuring efforts will result in costs of $6bn, of which $1.5bn has already been incurred. This forms part of the significant drain on Pfizer’s profits in the fourth quarter, with the $1.5bn paid out dwarfing the $250m in the corresponding period of 2007.

However, Pfizer’s legal costs were even greater, with the company paying out over $2.3bn in the fourth quarter to settle investigations into its marketing practices.

Despite these difficulties CEO Jeff Kindler remained upbeat, highlighting that Pfizer had exceeded its cost reduction target and achieved its financial objectives.

He added: “We made significant progress by: Establishing customer-focused business units; reprioritizing and refocusing our research on the greatest opportunities for scientific, medical and commercial success; and increasing our Phase III portfolio by approximately 60 per cent, from 16 to 26 programs at year-end.”

Over the past year Pfizer got a small taste of how generic competition is going to impact its revenues. Norvasc came off patent in 2007 and generic alternatives resulted in the revenues it generated in the US falling by 87 per cent last year.

This amounted to over $500m but compared with the succession of patent losses Pfizer is facing this is small change. The big one is Lipitor which is due to come off patent in 2011.

Revenues generated by Lipitor in the US fell by 12 per cent in 2008 but growth in international markets meant the product still brought in $12.4bn, a dip of 2 per cent.

This amounts to about 25 per cent of Pfizer’s total revenues for 2008 and filling the Lipitor shaped hole that will appear in the company’s balance sheet in 2011 has been a priority for Kindler.

He now believes this problem has been resolved, stating that the deal with Wyeth will “definitely” address the loss of patent protection for Lipitor.

Kindler said in a conference call that the company resulting from the merger will not rely on any one product for more than 10 per cent of its revenues by 2012.

Economy Freezes Expansion Plans for NC's PTRP, Alexandria-Developed Lab Space at George Mason Univ.

The economic upheaval has frozen expansion plans for a pair of projects in neighboring Southeastern states. The Piedmont Triad Research Park in Winston-Salem, NC, has held off on previously announced plans to redevelop 60 acres of the campus now occupied by buildings vacated about a decade ago by Reynolds American predecessor RJ Reynolds Tobacco, PTRP Director Bill Dean said.

"Right now, that's still in process and in discussion and in deliberations. Like everything else, with the economy, we will act cautiously," Dean said in an interview focused on his new role as chairman of the North Carolina Research Park Network.

"The primary thing for us is to provide a development that can bring about improvements in our technologies that are going to improve the economic base of the Triad region and create jobs. That's focus number one for us in the future — influencing the value proposition, if you will, for our community," Dean added.

PTRP and Baltimore developer Struever Bros. Eccles and Rouse have formed a partnership and have discussed redeveloping 2.19 million square feet of space within the tech park's northern district. Both parties have discussed transforming the site into a mix of biomedical, residential, and neighborhood retail uses.

In neighboring Virginia, George Mason University officials told the Washington (DC) Business Journal that Alexandria Real Estate Equities has notified the school it will not start construction as planned on an 80,000-square-foot facility that would have included 50,000 of speculative lab and incubator space for startups, and 30,000 square feet of wet labs for the university. The facility was set to be completed in 2010, but will open at least two years behind schedule.

"We were caught by surprise by the decision," Vikas Chandhoke, dean of GMU's College of Sciences, told the newspaper. "Now we have put everything back on the drawing board."

For GMU, "everything" means reconsidering bids from six other developers that sought to join the university as a co-developer of the project; as well as requesting subsidies for the project from the Virginia and Fairfax County governments — a proposition the Business Journal warned could be risky because both governments are cash-strapped. Virginia is struggling to plug a $2.9 billion budget shortfall; Fairfax County, a $500 million deficit.

GMU has projected its lab space would cost $300 to $400 per square foot to build out, or up to $12 million for its 30,000-square-foot portion. A total project cost has not been made public.

Covance Gears Up for Opening of New Drug Testing Lab Site in Chandler, AZ

Covance has started moving equipment into a 280,000-square-foot complex in Chandler, Ariz., after city officials granted final approval for the contract research organization's plans to transform the site into a new drug testing laboratory set to open in a couple of months.

Covance expects to begin operations around the end of March at the $150 million facility, at 2701 E. Ryan Road, spokeswoman Camilla Strongin told the East Valley Tribune of Mesa, Ariz. The company is installing some 7,000 pieces of equipment, a process it said will take several months.

The lab will provide drug-development services for major pharmaceutical firms, testing the toxicity of new compounds before they are used in humans. Because the work involves animal testing, the project has been opposed by animal-rights activists, who have protested at the construction site and appealed to public officials to keep the project from being built. In addition to arguing that the facility will abuse animals, project opponents have also alleged that the project will worsen area air and water pollution, and increase the risk of public exposure to toxic chemicals and exotic diseases — contentions strongly denied by the Princeton, NJ-based CRO.

The group Physicians Committee for Responsible Medicine sued Chandler officials in Maricopa County Superior Court in 2007 seeking to stop the project, only to see the suit dismissed in February 2008. Also last year, the Arizona attorney general's office ruled the city did not violate the state's Open Meeting Laws, rejecting a contention by the physicians group.

Covance originally planned to locate the lab at Price and Germann roads in the Price technology corridor but avoided a zoning battle by moving the project instead to a 77-acre parcel at Gilbert and Ryan roads.

The company has about 80 employees working in Chandler, a figure that will rise to between 200 to 300 employees once work begins, the Tribune reported. The first phase covers only 27 acres of the 77-acre site, giving Covance plenty of room to expand. The Chandler facility is intended to serve the company's clients on the West Coast.

Chandler officials have said Covance could eventually conduct human clinical trials at the site and employ thousands — as well as serve as an anchor that could lure additional life sciences employers to a city that already has 15 biotech companies with a combined 650 employees, Christine Mackey, Chandler's economic development director, told the newspaper.

URI Opens $59 Million Center for Biotechnology and Life Sciences, with Top Floor Unfinished

Rhode Island Gov. Donald Carcieri and administrators from the University of Rhode Island teamed up to cut a ceremonial ribbon marking the end of construction for the $59 million, 140,000-square-foot Center for Biotechnology and Life Sciences at URI's Kingston campus — though not the completion of the five-level facility, which opened for classes recently.

The center's top floor will remain unfinished until URI can raise the $5 million needed to complete the administrative offices and research space planned there, Jeff Seeman, dean of URI's College of the Environment and Life Sciences, told the Providence Journal. A classroom has been finished on the top floor and is being used.

The $5 million comprises most of an approximately $9 million cost overrun at the facility, for which state voters approved the state issuing $50 million in bonds in 2004. URI has, however, raised $3 million through federal grants, and $1 million through a donation from biotech giant Amgen.

"We continue to aggressively look for money," Seeman told the Journal. "But this is a bad time to look for money from private and company sources."

The center — the largest building project in URI history — includes facilities to support genomics, proteomics, and DNA sequencing.

And while the URI Foundation, an independent fundraising arm of the university, has raised $84 million toward its $100-million capital campaign set to be finished next December, most of that money is earmarked for purposes other than the biotech center, including undergraduate scholarships, endowed faculty chairs and athletics, Glen Kerkian, said the foundation president.

URI has asked state lawmakers to release $5.1 million in capital projects funds to finish the building — a request Carcieri included in his supplementary budget proposal.

State Rep. Eileen S. Naughton (D-Warwick), a member of the state House Finance Committee, told the Journal she would prefer to see incubator space for start-up companies included on the top floor instead of administrative offices: "Incubator space and the promise of job creation was part of the initial vision that sold the voters on this project."

While original plans for the center included incubator space, URI has since opted for additional classrooms and research labs, while saying that space for startups will be built in the research and technology park envisioned for development on campus over the next several years — but not under active development.

South San Francisco, CA, Warehouse/Distribution Plan Could Help Grow City Biotech Sector

The new owner of the 26-acre SFO Logistics Center in South San Francisco, Calif., has filed applications with the city to give the 572,000-square-foot warehouse and distribution facility, on San Mateo Avenue near San Francisco International Airport, a $23 million upgrade and modernization.

Centrum Properties is seeking approvals to renovate the entire building with 32 new loading docks, tenant upgrades, and five new smaller buildings averaging about 10,000 square feet. The project is expected to free up additional acres for redevelopment on the biotech-heavy east side of US Highway 101, said Marty Van Duyn, director of South San Francisco's Economic and Community Development Department.

Centrum and an equity partner, Angelo, Gordon & Co., purchased the property for $36.5 million from the US General Services Agency in August 2008. The property was formerly a half-empty warehouse for the US Postal Service and the Drug Enforcement Administration.

QED to Double Workforce, add Manufacturing Space on Cleveland's East Side

Quality Electrodynamics, a medical imaging startup on Cleveland's East Side, announced plans on Jan. 22 to double its workforce from about 40 to 80 employees, and add to its manufacturing space in the coming year.

QED, which opened in Mayfield, Ohio, three years ago, now occupies 7,200 square feet of office and manufacturing space, a figure that will expand to 27,000 square feet.

QED hires a new employee weekly, Hiroyuki Fujita, president and CEO, told the newspaper. QED released five new products last year and plans to release two more products — improved versions of coils used in MRI machines and other medical equipment — in the next few months, he added.

The company is on track to earn more than $10 million this year, Fujita said. QED coils have attracted customers that include Toshiba, Siemens, and General Electric.

The region has nearly 50 imaging companies with nearly 3,000 employees, according to BioEnterprise, a Cleveland-based nonprofit business development company. Toshiba and GE have operations within the region, as do Philips Medical Systems and Hitachi Medical Systems.

With $2 Million Grant from Indiana, PDS Biotechnology Moving Cincinnati Operations

PDS Biotechnology has received a $2 million grant from Indiana's 21st Century Research and Technology Fund toward a planned relocation of its Cincinnati headquarters and laboratory to Indianapolis.

PDS, a developer of disease-destroying nanotechnology, will move into a yet-to-be announced site in Indianapolis. There, it plans to develop its Versamune platform technology, which allows for delivery of targeted nanoparticles to the body's immune system, stimulating it to destroy infections and cancers, starting with incurable cancers associated with the human papillomavirus. PDS is completing preclinical development of its technology in collaboration with the US National Cancer Institute's Nanotechnology Characterization Lab, and plans to begin clinical trials in the next 18 months.

PDS Biotech is one of 63 businesses to receive more than a total $82 million from the 21st Century Fund since January 2006.

HHS Awards $487 Million Contract to Novartis for First US Cell-Based Influenza Vaccine Manufacturing Facility

The US Department of Health and Human Services has awarded a $487 million multi-year contract with Novartis Vaccines and Diagnostics to build the first US facility to manufacture a cell-based vaccine for seasonal and pandemic flu. The new facility is expected to increase the US capacity to make pandemic influenza vaccine by at least 25 percent.

Robin Robinson of the HHS' Biomedical Advanced Research and Development Authority told In-PharmaTechnologist,com that the plant will allow the US to produce sufficient quantities of vaccine within six months, faster than the timeframe of traditional egg-based manufacturing methods.

Under the contract, announced earlier this month by HHS, the agency and Novartis will split the cost of building the new cell-based influenza vaccine manufacturing facility in Holly Springs, NC. Novartis will cover 60 percent of the plant construction cost; HHS, the remaining 40 percent.

Novartis will also provide two new flu vaccines for seasonal flu or for pre-pandemic use. The new contract also will fund clinical bridging studies to compare existing Novartis vaccines to

new ones, including those developed in the new facility. If licensed by the FDA, the new cell-based vaccines made in the US could be purchased for by the federal government for vaccine stockpiles.

New Jersey-Based Biotechnology Start-Up Nexomics Signs Licensing Agreement with Rutgers

Nexomics Bioscience, a Highland Park, NJ-based biotechnology company, has signed a comprehensive license agreement with Rutgers, the State University of New Jersey. The accord provides Nexomics rights to a portfolio of intellectual property, including a suite of bioinformatics software and an early stage antibiotic screening methodology.

The agreement also gives Nexomics rights to use and further develop a novel ribosomal RNA methyltransferase assay that has applications in control of bacterial gene expression, control of bacterial growth, antibacterial chemistry, and antibacterial therapy.

An additional agreement has been announced with the Center for Advanced Biotechnology and Medicine, a research and teaching center that provides Nexomics access to laboratory space and equipment. Under the service agreement, Nexomics will have access to a number of scientific facilities supporting molecular biology, fermentation, protein purification, and nuclear magnetic resonance.

Kowa Deal Brings BioMed Realty's Center for Life Science | Boston to 91 Percent Leased

Japanese-owned Kowa Company, a conglomerate with a pharmaceutical division that focuses on fighting diseases such as arteriosclerosis, kidney disorder and diabetes, has agreed to lease the approximately 24,400-square-foot 17th floor at the Center for Life Science | Boston, the 700,000-square-foot research building now under construction in Boston's Longwood Medical Area.

The Kowa deal, plus an earlier agreement in which Children's Hospital Boston agreed to expand its space, brings the center to about 91 percent leased, Biomed said.

Makoto Life Sciences Bolts Cambridge, MA, for New Expanded HQ in Bedford, MA

Makoto Life Sciences, a Cambridge, Mass., drug developer specializing in small molecule target identification, has relocated its headquarters offices and laboratories to Bedford, Mass., from Cambridge, Mass. — a move that continues the trend of Boston/Cambridge biotech companies migrating west, north and even south in search of cheaper rents and lower operating costs.

Makoto has agreed to a long-term sublease of its new space, within the entire 20,000-square-foot 15 DeAngelo Dr., from sub-landlord Applied Biosystems, a business unit of Life Technologies. Located between Route 3 and Interstate 95, the building is owned by Alexandria Real Estate Equities. Makoto moved to the Bedford building from about 7,000 square feet at 124 Mt. Auburn St. in Cambridge

"The decision to move to Bedford was based on accessibility of the building to employees; homes, future growth opportunities and economics," Terry Russell, CEO of Makoto Life Sciences, said in a statement.

Jonathan Varholak, Chris McCauley, and Eric Smith of Richards Barry Joyce & Partners represented Makoto; while Cushman & Wakefield represented Applied Biosystems.

Wisconsin Commerce Dept. Awards $100K Loan to Eso-Technologies, Inc. in Waukesha County

Eso-Technologies of Hartland, Wis., a medical device maker focused on monitoring cardiovascular function, has been approved for a $100,000 Technology Venture Fund loan from the state Department of Commerce. The department has also certified the company as a Qualified New Business Venture eligible for early stage and angel investment under the state's Act 255, Gov. Jim Doyle announced.

Founded in 2007, Eso-Technologies developed an esophageal monitoring device designed to be less expensive, less invasive, and more effective than today's pulmonary catheters. The device is also designed for expansion to provide additional monitoring and therapeutic capabilities.

Eso-Technologies will use the state loan for prototype development, clinical trials, and related activities. Total project cost is $3 million.

University of Iowa Opens $8.5M Facility in Coralville with State's Largest Wet Lab Incubator

The University of Iowa has opened the $8.5 million, 35,000-square-foot BioVentures Center in the UI Research Park, a facility that administrators say includes the largest wet-lab business incubator in the state.

The center, at 2500 Crosspark Road in Coralville, Iowa, has 20 wet labs and 16 offices. The facility also features a board room, shared equipment room, break room, conference rooms, and a multi-purpose room that supports meetings of up to 60 people. More than 50 percent of the available space, eight labs and nine offices, is leased or committed.

The project began in November 2007, and was funded through Grow Iowa Values Funds and tax increment financing from the city of Coralville.

ASL Analytical, Cellular Engineering Technologies, Exemplar Genetics, KemPharm, Terpenoid Therapeutics, and Vertex Pharmaceuticals are the first companies set to occupy the facilities, the university said.

Batavia (NY) Med Tech Park's First Occupant May Be Community College's Nursing Program

The new Med Tech Park now in planning stages in Batavia, NY, may welcome as its first tenant the nursing program of Genesee Community College, the school has disclosed in a news release.

The program would occupy the second floor in the first building of the planned tech park, set to rise on roughly 30 acres on Assemblyman R. Stephen Hawley Drive. The second floor would consist of four classrooms, three nursing labs, a large group instruction room, and seminar space, the news release said.

The Genesee County Economic Development Center, which controls the tech park, envisioned it as housing biotechnology companies, medical equipment businesses, and other healthcare-related tenants. GCC's nursing program envisions occupying the new space in the 2009-10 academic year, Vice President for Finance and Operations Kevin Hamilton told the Batavia village Board of Trustees during its Jan. 12 meeting, according to the Daily News of Batavia.

Mass.-Based Proteomics Technologies Firm, Protein Forest, Opens UK Office

Lexington, Mass.-based proteomics technologies firm Protein Forest said that it has opened a European division headquartered in Newcastle upon Tyne, UK.

Protein Forest said that the new European base will include office space and lab facilities to support sales, product demonstrations, applications development, and collaborative efforts with European partners. Protein Forest's primary products include its ProteomeChip sample prep technology for mass spectrometry-based proteomics and bioinformatics products for mass spec experiments.

The new UK office is led by European Business Director Robert Marchmont, who joined Protein Forest from GE Healthcare. Russell Garlick, president and CEO of Protein Forest, said in a statement that Marchmont would be responsible for setting up dedicated sales and customer support teams and distribution networks within Europe.

New Biotech Center at URI Not Quite Fully Developed

A new $59-million biotechnology center officially opened at the University of Rhode Island, the centerpiece of an ambitious expansion of the Kingston campus and a potential catalyst for economic growth in Rhode Island.

The 140,000-square-foot facility boasts a 300-person auditorium and multiple laboratories, classrooms and research space.

What the biotechnology center lacks, however, is a finished top floor.

Despite the fact university officials have known since at least the summer of 2006 that the building would cost closer to $60 million than the $50 million voters approved in a 2004 bond referendum, the project remains about $5 million short. That’s how much it will cost to complete the administrative offices and some research space on the top floor of the five-level building, said Jeff Seeman, dean of the College of the Environment and Life Sciences.

When the building opened for classes last week, a classroom on the top floor was ready for use, but a research wing and the area designated for offices were incomplete.

At a July 2006 hearing at the State House, lawmakers questioned why offices for Seeman and his staff were planned for the biotech center. URI officials responded that it was not uncommon to include dean’s offices in major academic buildings and that they had been part of the original plan.

At the same hearing, URI officials told lawmakers they knew the project was running over budget by $8 million to $9 million due to escalating construction and material costs, and they planned to cover the difference through private fundraising.

To date, about $3 million has been raised through federal grants and a $1-million donation from pharmaceutical giant Amgen.

“We continue to aggressively look for money,” Seeman said. “But this is a bad time to look for money from private and company sources.”

URI’s independent fundraising arm, the URI Foundation, has already raised $84 million as part of a $100-million capital campaign that is scheduled to be finished next December. However, most of that money is earmarked for other purposes, such as undergraduate scholarships, endowed faculty chairs and athletics, said Glen R. Kerkian, the foundation president.

Instead, the state Budget Office says URI is asking lawmakers to release $5.1 million in taxpayer money — state RICAP funds used expressly for capital projects — to finish the building. The request is part of Governor Carcieri’s supplementary budget proposal. The General Assembly would have to approve the release of the money.

URI officials said that while incubator space was part of the original plan, they decided in the end to dedicate more space to classrooms and research. Since the conception of the biotech center, URI President Robert L. Carothers has proposed the university develop a research and technology park that would include incubator space. However, it is unclear when, or if, the park will be built.

The project has sparked other flash points. Last year, some lawmakers criticized the way URI oversaw construction, which was done by Rhode Island-based Gilbane Building Co. Lawmakers allowed URI to use a “construction manager at risk” method, which allowed the university to “fast track” the project and gave URI greater control — including over containing costs, said Robert A. Weygand, URI’s vice president of administration.

In the end, a legislative report found the “construction manager at risk” method did not make the project more costly. But lawmakers said they disliked the fact that several smaller contracts and purchase orders were not individually signed by university officials, potentially leaving the state open to liability.

Weygand said URI stands by the way the project was handled, and said that high-profile projects usually receive, and deserve, close public scrutiny.

“The Ryan Center was controversial at the time because it was expensive and it received a lot of attention,” Weygand said. “The fact is, we do more capital projects than anyone else in the state, with the exception of the [Department of Transportation], and we do them well.”

Weygand said the purpose of the building should not be obscured by controversy.

“This is a spectacular, state-of-the-art building,” he said, “and when people see it, they will understand why we are so proud of the design.”

Spending $26 Million to Expand Capacity at its Facility in Walkersville, MD

Lonza is spending $26m to expand capacity at its facility in Walkersville, Maryland, US as regulatory progress made with Osiris’ Prochymal looks set to kick start the era of cell therapies.

The firm will install three class 10,000 cell production suites as well as the requisite cleanroom and processing space at the plant, all of which will be housed in a 44,000 sq ft, purposed designed building.

A company spokesman said that a key function of the facility will be to provide manufacturing space for its contract work, including for the production of Prochymal under a contract signed with Osiris Therapeutics last year.

The drug, a graft-versus-host-disease candidate for transplant patients, was recently the subject of a “successful pre-Biologics License Application meeting” with the US Food and Drug Administration, according to Osiris and development partner Genzyme.

The Lonza spokesman also said that when fully operational at the end of Q1 2010 the Walkersville site will be capable of working with, keratinocytes, fibroblasts, vascular endothelial cells, renal cells, dendritic cells and myoblasts.

He commented that: “Cell therapy is still at an early stage of its life cycle. Currently, it is only a small portion of the total Lonza revenue. As cell therapeutics move from clinical development to commercial products, Lonza expects the revenue generation to become more significant.”

“Currently, demand for the cell therapy companies and products are primarily in North America and Europe. During this phase of development it is easier for manufacturing to be closer to the client company and to patients. Lonza plans to expand its cell therapy manufacturing base to other areas…as the market demand requires.”

The Walkersville site, which was bought from Cambrex in 2007 for $460m, currently employs 450 people in the fields of cell research, endotoxin detection and cell therapy manufacture. The expansion will create around 80 new manufacturing jobs.

Cogenics Enters Partnership with SinoGenoMax on Clinical Genotyping Services to China

By partnering with an established force in the Chinese genomics market Cogenics is hoping to gain access to clients beyond its primary markets in the US and Europe.

SinoGenoMax provides genomic services to local and international universities, research institutes and pharmaceutical companies. The partnership should give Cogenics access to these clients and expand the range of services that the companies can offer.

Michael Lutz, Global Manager of Cogenics, said: “The extensive pharmaceutical and biotechnology infrastructure and large number of clinical trials conducted in China make this an increasingly important market for clinical genotyping services.

“Our partnership with SinoGenoMax provides us with an established presence in China and an experienced international service partner who operates with similar platforms and high quality standards, thus expanding Cogenics’ offering to our growing global pharmaceutical customer base.”

Cogenics claims its clients include the top 20 pharmaceutical companies operating in the US and Europe. Companies in China will now have greater access to these services, which include next generation sequencing, gene expression and clinical and non-clinical genotyping.

In addition Cogenics can provide biomanufacturing support, nucleic acid extraction and biobanking for research and regulated environments.

Cogenics entry into China suggests it believes that the number of clinical trials conducted in the country will continue to grow, driving demand for related services.

Kendle to Increase Presence outside the U.S. with Establishment of Second Office in Ahmedabad in Western India

The company has had a presence in New Delhi, India since 2004 and has been expanding to allow its clients increased access to the nation’s favorable research conditions.

Asia/Pacific has been targeted by the company as a region that will help it maintain its impressive organic growth in a difficult operating environment.

Candace Kendle, PharmD, Chairman and CEO, said: "Expansion in the Asia/Pacific region, and India in particular, is essential to our continued success as a top global CRO.

“Our increased presence and capacity in the region will allow us to better meet the needs of our customers who are seeking to capitalize on India's cost-effective, yet high-quality clinical research capabilities to develop their compounds."

By continuing to expand outside of its regional base in New Delhi Kendle has given itself access to a greater proportion of the Indian population, which is one of the big attractions to companies looking to conduct trials in the country.

In addition to easing the recruitment of patients for clinical trials having access to a broad geographic area gives Kendle access to more of the talent pools spread around India.

Ahmedabad has become a focal point for the Indian pharmaceutical industry and multi-nationals looking to set up in the country.

This has been underpinned by the presence of renowned scientific education establishments and Zydus Cadila and Torrent Pharmaceuticals establishing their headquarters in the city.

Pfizer Signs Deal to Get Xoma’s Antibody Technology

Yet another sign of pharma heavyweight Pfizer's moves to break onto the biopharma scene emerged, with news that the company has signed a multi-million dollar licensing deal to get its hands on US firm Xoma's antibody technology.

Pfizer has paid an upfront fee of $30m for non-exclusive worldwide rights to Xoma's patented bacterial cell expression technology, gaining access to use the system for phage display and other research, as well as development and manufacturing of antibody products.

Xoma will also receive milestone payments and royalty fees on future sales of all products subject to the license, including products currently in late stage clinical development.

Pfizer is just the latest major pharma to pick up on Xoma's antibody discovery and development platform, with over 40 other companies having signed licenses to gain access to the company's bacterial cell expression (BCE) technology.

Biologics is a key area of future growth for Pfizer, who appears to be expanding rather rapidly in a bid to make sure it has the resources available to exploit this booming field and be a contender in the burgeoning biopharma market.

The BCE technology that Pfizer has banked on to help establish itself in the biopharma field is touted as an enabling technology for antibody discovery and production, and with fellow licensees in the form of Merck & Co, Genentech and Genzyme among others, Pfizer would appear to be in good company.

Genentech's drug Lucentis (ranibizumab) for wet age-related macular degeneration was in fact the first product manufactured under a license using Xoma's BCE technology, and was approved in the US in June 2006 with EU approval following in January of this year.

Worldwide sales of Lucentis over the second quarter of 2007 totaled $285m, with the drug representing the major contributor to the $4.3m in royalties earned by Xoma over Q2.

Cimzia (certolizumab), an anti-tumor necrosis factor (TNF) alpha antibody fragment developed by UCB is another late stage drug produced using Xoma's BCE technology, and has been submitted for regulatory approval for Crohn's disease.

Xoma has mammalian and microbial expression technologies in its portfolio designed to increase product yield. The company's microbial production system produces high level expression of recombinant proteins in E. coli, and both the mammalian and microbial systems utilize Xoma's proprietary vectors, cell lines, animal product-free media and protocols.

That Pfizer is pushing ahead with it biologics plans comes as no surprise. Biopharmaceuticals is the fastest growing sector in the industry, with biologic drugs expected to make up a significant portion of pharma firm portfolios within a matter of years.

Only last week US-PharmaTechnologist.com covered the expansion of Pfizer's biologics R&D site in Chesterfield, Missouri, a $50m investment that will effectively double the size of the facility.

The company is also toying with the idea of a small scale biologics manufacturing plant in Ireland, though is being very cagey regarding concrete plans for the site in Shanbally.

Pfizer's first therapeutic monoclonal antibody is due to be launched in the next year, according to a company representative talking at this month's Drug Discovery and Development of Innovative Therapeutics (DDT) conference in Boston, an anti-cancer treatment that will target the CTLA-4 receptor.

By 2009, the company hopes that biologic drugs will make up 20 per cent of its portfolio.

Sanofi-Aventis to Sell Liquid Drug Manufacturing Plant in Colomiers, Southwest France, to Unither

Unither, which bought Sanofi’s Coutances plant in 2001, will continue to make several products at Colomiers on the latter’s behalf on a contractual basis, including the world leading cough syrup Rhinathiol (carbocistein).

A Sanofi spokesman told in-PharmaTechnologist that the firm’s decision was in response to a decline of the global market for liquid forms that has been going on for the last few years, rather than falling sales of any one particular drug produced at the site.

He explained that: “Most of the drugs [made at the facility] are moving to over-the-counter status and, as a result, are not likely to see dramatic growth in the future.”

The Sanofi representative added that the firm had decided to enter into the transaction and explained that it will be discussed at a consultation with the facility’s workforce, as is required by French law.

He also said that Amiens-headquartered Unither will maintain full production operations at the Colomiers plant and is expected to retain the facility’s 200-strong manufacturing workforce.

Despite these comments, the meeting may well be a difficult one for Sanofi given that its Colomiers employees were described as being “surprised” to learn of the sale in a report on the Ladepeche.fr news website.

Unither, which was set up by former Sanofi employees in 1993, currently has manufacturing facilities in Amiens, Bessay, Bordeaux, Gannat, Paris and Coutances at which it employees nearly 600 people.

Novartis Will Receive a Further $487 Million (€366m) from the U.S. HHS for Its Cell-Culture Flu Vaccine Plant in Holly Springs, NC

The facility, which will boost US vaccine production 25 per cent when fully operational in 2012, has been under construction since 2007 when Novartis won its original Department of Health and Human Services (HHS) contract.

The new deal calls for Novartis to develop two new vaccines, for either seasonal or pandemic use, and provides funding for clinical bridging studies designed to compare the firm’s vaccines to existing products in terms of safety and efficacy, potentially expediting their approval by the US Food and Drug Administration.

As Robin Robinson of the HHS’ Biomedical Advanced Research and Development Authority (BARDA) said, the plant and the flexibility it provides are vital to the country’s pandemic plans.

“In a pandemic we would need vaccine ready within six months,” Robinson explained, adding that this goal could not be accomplished using traditional egg-based manufacturing methods.

Andrin Oswald, CEO of Novartis Vaccines and Diagnostics commented that: "The site will provide jobs for more than 300 highly skilled people with the capability to produce cell-based seasonal flu vaccine, pre-pandemic vaccine and 150m doses of pandemic vaccine within six months of the declaration of an influenza pandemic."

The ability to freeze cell cultures means that they can be made available for large scale production in a fraction of the time taken to procure the millions of hens eggs needed to make vaccine using the traditional approach, significantly reducing manufacturing lag.

Such flexibility and speed means production can be delayed until the specific virus strain responsible for an epidemic, or pandemic, has been properly identified. This avoids the best -guess, blanket approach of combining several likely strains in a vaccine that is necessitated by the longer manufacturing times needed for egg-based production.

Novartis is at the forefront of cell-culture vaccines through its partnership with Dutch firm Crucell and access to the latter’s popular PER.C6 cell line. In 2007, Novartis’ Optaflu, production of which is due to be switched from the firm’s plant in Marburg, Germany to Holly Springs, became the first cell culture-derived vaccine to be cleared by European regulators.

Joerg Reinhardt, Novartis COO said: "We believe that this contract award underscores the US Government's commitment to ensure pandemic vaccine supply, and reflects their confidence in Novartis.”

The announcement of the new contract coincides with the release of a HHS report highlighting “major gaps” in the country’s strategy for coping with the predicted influenza pandemic.

The authors said that although progress has been made, the protection of government workers as a way of maintaining vital infrastructure was not being given sufficient thought, commenting that “even the best plans can fail if managers cannot accommodate significant absenteeism.”

Syral Centre of Excellence to Boost Innovation

Syral is building a new centre of excellence which it hopes will strengthen innovation by working directly with its customers in the application of its sweeteners and proteins, among other ingredients.

The new building, next to the ingredients company’s European headquarters in Marckolsheim, France, will include analytical laboratories, a large pilot hall and facilities for sensory research.

Syral’s ingredients portfolio includes starches, sweeteners (glucose syrups, dextroses, maltodextrins and polyols) and vegetable proteins.

A spokeswoman for Syral told FoodNavigator.com that the centre would bring R&D facilities under one roof to make it easier to meet customers and work with them on product development, trials and on presentations about new product concepts or improved products.

She added that the centre was scheduled to open late spring this year and it followed Syral’s acquisition of part of Tate & Lyle’s European starch ingredients business in 2007.

The spokeswoman said: “With this acquisition we have increased our operations capabilities.

“We have many customers who were previously supplied by Tate & Lyle so we want to provide something more. “Our strategy is development. We want to increase innovation.

“I think the building of this application centre is proof that we are increasing our capacity in innovation from the application point of view.”

Equipment in the pilot hall will cover a range of food applications, from confectionary and bakery to convenience food and meat, as well as dietetic products.

Syral said it will focus on customer-oriented research and development which will enable the company to develop new and improved products that meet consumer requirements.

The company also announced it will be enlarging its technical support team to assist customers in industrialization and problem solving.

The centre can be used for ingredients across its portfolio range including areas such as fiber enrichment, protein enrichment and texturing properties. However, there is a focus on sweeteners.

Anne Wagner, vice president innovation at Syral, said: “The pilot and laboratory facilities will be open to our business partners in order to develop innovative sweetener formulations or to rework existing ones, specifically but not exclusively aiming at nutrition and health claims, which have been our main research topic for the last two years.”

Syral has a pro forma turnover of €930m and claims to be the third largest producer of glucoses and other starch-based sweeteners in Europe.

On October 1st, 2007, Syral finalized its acquisition of five Tate & Lyle production facilities, having obtained the approval of EU competition authorities.

It now owns six production sites: Marckolsheim, Nesle (France), Aalst (Belgium), Greenwich (UK), Saragossa (Spain) and Saluzzo (Italy).

Robinson Pharma Audit Confirms cGMP Compliance

Robinson Pharma Inc (RPI), a dietary supplement contract manufacturer, has said its latest quality audit has confirmed continued cGMP compliant operations.

The audit, performed by Specialized Technology Resources (STR), grants the company continued certification under the Retail Qualification Program (RQP). These standards were originally established to assure the safety, purity and label claim compliance of supplements sold in a major national retail chain.

According to Robinson Pharma’s vice president of marketing Kenn Israel, the firm’s investment in quality has already allowed it to expand into the private label market.

“Partnering with STR, along with other key strategic initiatives, has facilitated the transformation of RPI from a contract manufacturer to a competitive private label supplier of some of the leading marketers of dietary supplements in the United States and other international markets,” he said.

The STR audit – which confirms the purity, safety and labeling of products – tested Robinson Pharma’s standard operation procedures, staff qualifications and staff training program. It also evaluated facility adequacy and cleanliness.

Aspects of the manufacturing process that were reviewed include receipt and authentication of ingredients, the production process, post production product analysis, product handling, packaging, storage, and record keeping, said RPI.

The firm first committed to the Retail Qualification Program last year.

Certified quality standards are now becoming indispensible in all levels of the supplement manufacturing industry after the introduction of new quality regulations last year.

FDA’s good manufacturing practices (cGMPs) for supplements, designed to ensure quality, safety and consistency, have already been adopted by large manufacturers in the US (over 500 employees). Mid-size companies are expected to comply by June this year, while small firms (less than 20 employees) have until June 2010 to comply.

Robinson Pharma, which can produce 12bn soft gel capsules per year, said it has made “significant investments” in manufacturing systems that ensure constant monitoring of all aspects of its production process.

It said it has designed systems for ingredient receipt and testing, pharmacy and pre-production processing, manufacturing, post production testing and packaging.

Much of this work was conducted in partnership with STR, which RPI said provided “guidance and objective perspective” on its progress and execution.

HHS Agencies Offering New SBIR Grants

Several branches of the Department of Health and Human Services have invited eligible businesses to apply for Small Business Innovation Research grants, according to the National Institutes of Health.

The new SBIR grants will be made by NIH, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Administration for Children and Families.

Small business concerns in the US that have the research capabilities and technological expertise may apply for Phase I or Phase II funding. Phase I grants are designed to establish the technical/scientific merit and feasibility of the proposed studies, and offer up to $100,000 for a period that is normally less than six months.

The aim of Phase II grants is to continue the research and development efforts begun in Phase I, and they may provide up to $750,000 for two years. The second phase grant award levels and project periods are "statutory guidelines, not ceilings," NIH said in the announcement.

The SBIR program is intended to stimulate technological innovation in the private sector; strengthen the role of small business in meeting research needs; increase the commercial application of Federally-supported research results; foster and encourage participations by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program; and improve the return on investment from federally-funded research that benefits the nation.

NCRR Gives USC $22.2 Million for National Bioinformatics Center

The University of Southern California has landed a $22.2 million grant from the National Institutes of Health to become a central coordinating point for a national bioinformatics and biomedical data collection and integration project, according to NIH's Biomedical Informatics Research Network.

The National Center for Research Resources funding, which will span five years, will support the establishment of the Biomedical Informatics Research Network Coordinating Center at USC, which the university said will make it "a central clearing house" for information from the BIRN.

BIRN, which was launched in 2001, was formed to foster large-scale collaborations in biomedical science by using new information technologies, and it aims to implement and distribute shared resources that will be usable to all biomedical researchers involved in disease diagnosis and treatment studies.

The need for a center for biomedical data springs from the "overwhelming quantity of data that geneticists and others produce," which can keep medical researchers from connecting with new discoveries and therapies.

The center will be led by USC Professor Carl Kesselman at the Viterbi School of Engineering Epstein Department of Industrial and Systems Engineering and the USC Information Sciences Institute. "Without a sophisticated bioinformatics capability — which only top engineers can provide — we cannot hope to translate the basic science into drugs and treatments that will improve the quality of life," Kesselman said in a statement.

He also said that the BIRNCC program "can accelerate the rate of discoveries for many areas of biomedical research."

The BIRN program has data centers at universities across the country that are involved in data collection, storage and management, quality assurance and analysis, and data sharing, integration, and discovery.

Barack to Business in 2009

GEN News Highlights

By Stephen K. Klasko, M.D.

As with any morning after a big party, the election of Barack Obama to the presidency of the United States in one of the most difficult economic, social, and political times in our history has brought a mixture of optimism and concern among many different sectors of the economy.

There are no areas, however, with the potential for more explosive political change than healthcare, biotechnology, and information technology. From the vantage point of a dean and CEO of an academic medical center that has thrived on an entrepreneurial academic model and on partnerships with industry and the private sector, the landscape the new president will face on the day after the inauguration appears to pose several challenges.

More than any other candidate, President Obama has bought into the Institute of Medicine’s statement that “the American healthcare delivery system is in need of fundamental change. The current care systems cannot do the job. Trying harder will not work. Changing systems of care will.” The desire to fundamentally change how we do business in healthcare has implications for everyone touched by healthcare, namely all of us. Most importantly it will impact healthcare information technology, the NIH and federal funding of research, FDA and pharmaceuticals, as well as investment and ease of operation for biotechnology start-ups.

Impact on Big Pharma

There has been much written about President Obama’s tripartite policy on pharmaceuticals—increased use of generics, importation of drugs from other developed countries, and the repeal of the Medicare Drug Improvement and Modernization Act, so that Medicare can negotiate prices with pharma similarly to the VA system. In fact, almost half the expected investment in evidence-based medicine and healthcare information technology will likely come from these savings.

The question remains how the totality of the Obama plan will impact pharma and device companies. While drugs account for only 5% of healthcare costs in this nation, they represent half of Medicare out-of-pocket costs. In fact, in this depressed economic time, I see patients on a regular basis who have self-adjusted their medication dosages so as to extend the time before they need a refill.

On the one hand, if there is truly an expansion of healthcare coverage, then the increase in the number of units sold may outweigh any Medicare-negotiated price decreases. While most of the chatter has been about the effect on big pharma, of concern to us in academia is our reliance, especially with decreased NIH funding, on investment from biotech start-ups as well as their reliance on partnerships with big pharma.

Embryonic Stem Cells

The expected immediate repeal of the embryonic stem cell ban will stimulate research as long as there is a concomitant increase in stem cell funding. If there is only an opening of the disapproved lines without additional funding, it may actually cause a reduction in investment for the very areas of adult stem cell research that American researchers have had to develop given the current restrictions imposed by the Bush administration.

The federal restrictions have also spurred significant state funding of stem cell research, most notably in California. Given the current economic crises, it may be easy for the states to assume that all is well and now the federal government will carry that burden. So, despite all the optimism, the jury is still out as to whether or not there will be increased global stem cell funding.

Funding Basic to Translation Research

From an academic medicine perspective, nothing has been more depressing than the decrease in NIH funding, especially since much of our faculty and research hiring in the ‘90s was consistent with the then expansion of translational research funding. There are many of us who expect this administration and Congress to approve a 3% or 4% increase in available funding from the NIH with the potential for a $1 billion or more stimulus package.

More important than the numbers, however, is this administration’s commitment to funding in specific areas. Senator Obama in 2006 sponsored the Genomics and Personalized Medicine Act, which increased funding for research in how a person’s genetic makeup affects their propensity for disease and response to treatment.

This Act also expanded the genomics workforce, provided a tax credit for development of diagnostic tests that can improve the safety and effectiveness of drugs, and invested in protecting genetic privacy. Those of us who are on the academic or entrepreneurial side of this industry should see significantly increased opportunities.

Finally, we look at the fate of the SBIR and STTR initiatives, which are important factors in the growth of biotechnology academic entrepreneurialism. Some of the greatest technology in development will be lost and unavailable to commercialization if the government does not look for ways to help the NIH increase its funding for true translational research.

James Greenwood, president of BIO, made this clear immediately after the election. “You can’t simply go after big pharma on pricing and not expect it to have an impact on the most innovative young companies.” Future healthcare issues that decrease the ability of any company, big or small, to recoup and make a reasonable profit on the sale of drugs or devices will have a profound impact on future R&D of new products, relationships with academic scientists, and the very cycle of innovation that President Obama will need to drive the future of healthcare.

Healthcare IT

Any explosive change cited in this article, however, pales in comparison to the goal of achieving universal implementation of interoperable electronic health records within this term. In fact, President Obama has been very specific about spending $50 billion dollars over five years to achieve that goal. To put that in perspective, President Bush stated in 2005 that all records should be electronic by 2014, and he invested $100 million per year to achieve that goal.

Despite the huge increase in funding, it may not be enough. There are many analysts who believe that it will take about $28 billion per year in infrastructure and incentives. While prognosticating in print is a dangerous exercise for journalists or deans, I suspect that when you wake up in 2015, much will have changed. For one thing, the day of the scribbled prescription will be over. It is a $6 billion dollar problem in this country, and there is no other part of our life where we would take an unreadable piece of paper, stuff it in our pocket, hand it to a clerk, who hands it to another professional, and hope that it works out alright. Nonetheless, we trust our healthcare with that process.

Change Is Inevitable

So it’s the morning after the inauguration, the heady hope of change has been in the air since early November, and the reality of the challenges ahead for healthcare and the biotechnology industry are as real as the coffee on our breakfast table. The one thing that everyone agrees with is that healthcare is a $1 trillion plus industry in transition, and there will be opportunities available that have not occurred since the formation of Medicare some 40 years ago.

Whatever side of the healthcare equation you are on—patient, provider, industry—change is in the air. There will be winners and losers, and not all is certain, except that technology will expand as will patient demands and expectations. If you are in a healthcare-related business, strap yourself in—the next six years will test us to an unprecedented degree. Most of us believe that when the Obama library is being constructed, very little about healthcare and biotechnology will look as it did in 2008.

Stephen K. Klasko, M.D., is CEO, USF Health, dean of the College of Medicine, University of South Florida.

Small Biotechs Falling Ill

While Maryland's largest and most successful biotech, MedImmune, proceeds at full speed on its expansion projects in the state, many of its smaller counterparts are struggling amid the recession.

Numerous smaller biotechs, including Avalon Pharmaceuticals of Germantown and Novavax of Rockville, have announced layoffs. Venture capital, a significant source of funding for life sciences businesses, fell by 21 percent last year from 2007 to $28 billion, according to Thomson Reuters and the National Venture Capital Association.

Moreover, 92 percent of venture capitalists foresee less venture investment in 2009 from last year, according to a survey by the Arlington, Va., association. But in one sign of hope for biotechs, the sector was seen as the second-most-attractive industry for investment stability and growth, behind only clean technology.

"Getting institutional vesting is harder in this economic climate, more so for small biotechs," said Tricia J. Richardson, senior manager for investor relations for Novavax. "We are all feeling the pinch and taking proactive measures."

Biotechs are particularly vulnerable to recessions, as they have a great need for capital, said Anirban Basu, chairman and CEO of the Sage Policy Group, a Baltimore economic and policy consulting firm.

"Many of them are still trying to get a product to market," Basu said. "It's a capital intensive industry."

The recession is also having an impact on foreign orders, said Martha Knight, executive and scientific director of CC Biotech. The company, which works on new separation technology, has maintained an office in the Maryland Technology Development Center incubator in Rockville since 2006.

A customer in South America recently postponed an order due to volatility in exchange rates, although another from Japan went through as planned, Knight said.

"We have worked on lower-cost technology to help us get through these times," she said.

Meanwhile, MedImmune, which is owned by British pharmaceutical giant AstraZeneca, created some 400 new jobs last year in Maryland and will have about the same number of new positions this year with an expansion in Frederick, said Perla Copernik, a company spokeswoman. The company has some 3,000 employees, with at least half in Maryland, she said.

MedImmune is adding 355,000 square feet to its 91,000-square-foot manufacturing facility in Frederick, where it manufactures its biggest money-maker, Synagis, a treatment for children's respiratory problems. The expansion is due for completion this year, although its manufacturing process requires the approval of the U.S. Food and Drug Administration, which could take until next year, Copernik said.

Plans are in the works to add a 250,000-square-foot research facility to MedImmune's Gaithersburg headquarters. Construction is slated to start by summer and be completed by 2011.

Having well-positioned products at the right time is key to MedImmune's success, said Richard A. Zakour, executive director of MdBio, a division of the Tech Council of Maryland. "They are farther along in the cycle," he said.

MedImmune even has its own venture capital funding division, which formed in 2002. This week, MedImmune Ventures led a $22 million funding round for Hydra Biosciences, a Cambridge, MA, company working on new pain relievers with fewer side effects than current treatments.

"Hydra Biosciences' strong management team and expertise in [transient receptor potential] ion channel receptor drug discovery has the potential to create first-in-class drugs for significant diseases, such as pain, inflammation and pulmonary disease," said Maggie Flanagan LeFlore, managing director of MedImmune Ventures, in a statement.

Among Maryland companies that have benefited from MedImmune Ventures funding is Sequoia Pharmaceuticals of Gaithersburg, which is developing new treatments for HIV/AIDS and hepatitis C virus-induced hepatitis.

Human Genome Sciences of Rockville is another large biotech expecting growth in the near future. Better times are just around the corner, CEO and president H. Thomas Watkins said in a recent conference call. He expects revenues to reach $250 million this year, as HGS delivers 20,000 doses of its anthrax vaccine to the federal government.

The company reported positive results of Albuferon's first phase 3 trial to treat chronic hepatitis C. Results of Albuferon's second phase 3 trial are expected in March, and if those are successful, global marketing applications will be filed in the fall, Watkins said. Applications for another product, LymphoStat-B, to treat lupus are also expected by the first half of 2010, he said.

For the first nine months of 2008, the company reported that revenues increased by 21.5 percent to $35.6 million from the same period in 2007. Its net loss widened to $189.3 million for the first nine months of last year from a net loss of $169.6 million in the same period of 2007.

"We are very much looking forward to 2009 and 2010," Watkins said.

For the 2009 legislative session, industry leaders would like to see the biotech investment tax credit doubled to $12 million and more support provided for higher education and infrastructure. But Gov. Martin O'Malley's budget released this week has the tax credit program funded at only $6 million in fiscal 2010.

Support for such incentives, along with higher education and strong infrastructure, cannot be turned away from, even in a recession, because they provide a solid foundation for economic growth and stability, said Edward M. Rudnic, chairman of the Tech Council and former CEO of MiddleBrook Pharmaceuticals in Germantown.

Last year, O'Malley unveiled Bio 2020, a $1.3 billion, 10-year initiative that includes subsidies and a Maryland Biotechnology Center to serve as a one-stop shop for life science companies wanting to relocate or expand in the state.

His 2010 proposed budget includes $70.9 million for Bio 2020 programs, which the report says exceeds O'Malley's original promise by $12 million.

The budget proposal also includes $5 million for the new Maryland Biotechnology Center within the Department of Business and Economic Development, $18.4 million for stem cell research, $32.2 million in capital funds for the Germantown Bioscience Center and $5 million in capital funds for the East Baltimore Biotechnology Park.

On the federal side, Rachel King, CEO of GlycoMimetics of Gaithersburg, called for more research funding for the National Institutes of Health in Bethesda in testimony before a U.S. House Energy and Commerce subcommittee late last year. NIH is a key source of funding for many local biotechs through grants and other mechanisms.

Anthony S. Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, said he expected a slight increase in federal research funds next fiscal year.

"I think we will see that level of support increase more after next year," said Fauci, who spoke at the Health for All Blue Diamond Inaugural Ball at the Smithsonian Institution's National Museum of Natural History this week. One of the organizers of that event was the Vineeta Foundation, a health and human rights organization that was the brainchild of late North Potomac epidemiologist Vineeta Rastogi, who died of cancer in 1995 at the age of 27.

BIO, a Washington, D.C., trade lobbying group, is calling for government financial relief for the industry. The organization recommends changing tax laws to help biotechs with drugs in the early stages of development that have not yet made money.

Among the bills that Congress is expected to consider this year is one allowing NIH funding of more embryonic stem cell research. King also recommended more federal tax incentives to reinvigorate investment in the biotech industry.

"The biotechnology industry can serve as an engine to build an innovation-based economy and help create economic growth by creating high-value, high-wage U.S. jobs," King said.

Maryland's Bioscience Industry

More than 370 bioscience companies.

Seventeen are publicly traded bioscience companies, with more than 20 companies conducting clinical trials for new biotherapeutics.

More than 34,000 private-sector bioscience employees, with a comparable number in university and federal research institutions.

State investment of more than $450 million in bioscience infrastructure.

Source: Maryland Department of Business and Economic Development

WORLD

Bayer Builds World's Largest Production Plant for Carbon Nanotubes in Chempark Leverkusen

Bayer MaterialScience has begun work on the construction of a new facility for the production of carbon nanotubes (CNTs) in Chempark Leverkusen. The new plant will have a capacity of 200 tons/year, making it the largest of its kind in the world. The company is to invest around EUR 22 million in the planning, development and construction of the plant, which will create 20 new jobs. "We are investing in a key technology of the future that will open up a broad range of new applications for us. We intend to utilize this opportunity to the full. At the same time, the construction of the new CNT facility is a declaration of faith in Leverkusen and the State of North Rhine-Westphalia as an industrial location," said Dr. Wolfgang Plischke, the member of the Bayer AG Board of Management responsible for innovation, technology and the environment, at a press conference to mark the start of construction. Current forecasts predict that the global market for carbon nanotubes will grow by 25 percent a year. In ten years, annual sales of these products are expected to reach US-Dollar 2 billion.

Following the official start of construction work, representatives of the Innovationsallianz "CNT - carbon nanomaterials conquer markets" - in brief: Inno.CNT - met in Chempark Leverkusen for their kick-off event. In this alliance, which is supported by the German Federal Ministry for Education and Research (BMBF), more than 70 partners from industry and science have joined together to develop new technologies and applications for CNT-based materials.

Bayer MaterialScience is one of the few companies that can produce carbon nanotubes of consistently high quality on an industrial scale. A pilot plant with an annual capacity of 60 tons has been in operation in Laufenburg in southern Germany since 2007. Production involves a catalytic process in which the carbon nanotubes are obtained from a carbon-containing gas at elevated temperature in a reactor. "Bayer is investing in this, the world's largest CNT production plant, because we are convinced of the technological and economic efficiency of the process," said Plischke.

With the company's know-how, Bayer can now take a product from the research laboratory and smooth its progress into a broad spectrum of applications relevant to society, such as energy, the environment, mobility, safety and construction. Baytubes® - the brand name for Bayer's carbon nanotubes – are already being used to produce tough, extremely strong, lightweight materials. This means, for example, that rotor blades for wind turbines are more energy-efficient, that transport containers weigh less and that sports equipment can be made more robust.

Four Indian Vaccine Makers have License Suspended after Failing GMP

Four of India's biggest vaccine manufacturers have had their licenses suspended by the Indian government after failing to meet good manufacturing practice (GMP) requirements, according to local media reports.

The firms involved are the Pasteur Institute of India in Tamil Nadu, Haffkine Bio-Pharmaceutical Corporation in Mumbai, BCG Vaccines in Tamil Nadu and Central Research Institute (CRI) in Himachal Pradesh, according to India's Economic Times.

Reportedly, the Central Drugs Licensing Approving Authority, headed by the Drug Controller General of India (DCGI), has immediately halted production at the sites, which make vaccines for a range of diseases such as malaria, cholera, rabies, polio, diphtheria, tetanus, yellow fever and typhoid.

Their licenses have been revoked until the companies make changes to their infrastructure and processes and begin to fully comply with GMP standards. This might take "six months or a year", a government source said.

According to an Express India source, the CRI was found to be in "serious violation" of GMP norms after an inspection by a team of experts and drug officials was conducted in August, 2007. At the time, the institute reportedly sought a grace period of two years to remedy the situation and requested between 35 crore ($7m) and 55 crore for the purpose, but despite this, the team visited the CRI again in the first week of January this year and upon finding that the violations still persisted, served the organization with the suspension order shortly after.

The proactive move may be part of a crackdown by the Indian government, keen to claw back its international reputation after the country was identified by the World Health Organization (WHO) for having manufacturing standards that fall short of GMP, particularly in the field of vaccines.

According to the Economic Times, it was the WHO that recommended the suspension of the four firms' licenses and was even considering removing India from its list of countries to source vaccines for its global projects.

This would have been a severe blow to the industry, as most of the vaccine makers, including those in the private sector, have large contracts with WHO.

However, according to India's Organizer, some smell a conspiracy, citing the CRI as an example, which is famous for its work in the research, testing and manufacturing of vaccines for countries around the world.

The CRI manufactures vaccines and medicines and makes supply of worth 20 crore to the Indian government at a very cheap price and according to an Organizer source, this was "a cause of worry" to the multinational companies (MNCs) in the region, who were being prevented from "capturing the market of vaccines".

In addition to a suspension of its manufacturing license, company sources told the Organizer that the CRI has also had its supply of medicines to the government stopped until further notice, meaning that "in the present circumstances, the huge market of vaccines would be in the hands of MNCs".

HHS Establishes FDA Presence in India

HHS secretary, Mike Leavitt, and FDA commissioner, Andrew C. von Eschenbach, M.D., reported the opening of HHS/FDA offices in New Delhi and Mumbai. The aim is to improve safety and quality, which will facilitate the smooth flow of trade.

HHS/FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the U.S. Along with the office director, HHS/FDA will have four inspectors and five senior technical experts who will cover food, medical devices, and medicines.

These HHS/FDA personnel will provide technical advice, conduct inspections of facilities that export to the U.S., and work with Indian government agencies and the private sector to develop certification programs to allow the efficient flow of safe HHS/FDA-regulated goods between the U.S. and India.

“Through these offices, we can work more closely with manufacturers to share best practices and ensure producers build quality and safety into food and medical products,” remarks Leavitt.

In January 2008, Leavitt and von Eschenbach visited India to start discussions with Indian industry about the issue of product safety and with the Indian government on the potential of posting HHS/FDA personnel to the U.S. embassy in New Delhi and the U.S. consulate in Mumbai.

India is the fourth-largest exporter by volume of drugs and biologics, especially generic pharmaceuticals, to the U.S. India is also a significant exporter of food products.

These offices are part of HHS/FDA’s Beyond Our Borders Initiative, which will place 35 HHS/FDA personnel in 14 locations around the world. The goal is to expand HHS/FDA consumer-protection efforts beyond the U.S. and form collaborative partnerships with governments and industry on product safety.

With the opening of these offices, HHS/FDA now has an in-country presence in China, Central America, India, and Europe. HHS/FDA also plans to post FDA personnel to several more locations in 2009, such as Mexico, South America, Europe, and The Middle East.

NUI Opening Mass Spec Facility Using Agilent Instruments

Agilent Technologies announced the opening of a mass spectrometry facility focused on functional genomics, proteomics, lipidomics, and metabolomics research on the National University of Ireland's Galway campus.

The collaboration is part of Agilent's Academia Program, which is aimed at assisting universities and creating research partnerships. The new Biological Mass Spectrometry Facility will rely on Agilent's Q-TOF and QQQ platforms, which will also be used for demonstration purposes for the company's customers. For its part, NUI will provide application notes and data for applications using the Agilent mass spec platforms.

The mass spectrometers will be run by primary investigators David Finn, a pharmacology and therapeutics lecturer and co-director of NUI Galway's Centre for Pain Research; Niclas Karlsson, a bioinformatics researcher; and Brendan Harhen, a biochemistry graduate who will support the center's quantitative needs.

NUI Galway Vice President for Research Terry Smith said the move is part of the institution's recent efforts to increase its mass spectrometry capacity, particularly as it applies to life science research.

Quintiles Works with India’s Apollo in Clinical Trials

Contract research organization (CRO) Quintiles has announced a deal with India’s Apollo Hospitals Group that will see the two firms collaborate in opening a Phase I clinical trials unit.

The move will allow Quintiles to bolster its presence in the fast-growing Indian clinical research market, which is expected to more than double in size by 2012, according to research published earlier this month by research firm RNCOS.

The new unit is due to open in early 2010 on Apollo’s hospital campus in Hyderabad, and will start with a capacity of approximately 50 beds, which will increase to 100 beds if demand develops as predicted.

Apollo is the largest private hospital chain in India, while Quintiles is the biggest CRO globally with 14 per cent of the world market. Their new unit, which will evaluate compounds developed both within and outside of India, will be Quintiles’ fifth location in India, but the first offering Phase I services.

Quintiles’ other Phase I units are located in England, Kansas in the US and Sweden (Lulea and Uppsala).

India is increasingly attractive as a hub for clinical research thanks to a huge patient pool representing both chronic and infectious diseases, as well as easy recruitment of patients. RNCOS also estimates that cost savings afforded by locating trials in India can be 50 to 75 per cent.

“This new Phase I unit will draw on the existing experience of Quintiles staff in India, including our established cardiology group,” commented Eddie Caffrey, Quintiles’ senior vice president, global Phase I.

Quintiles and Apollo anticipate their combined investment for the new unit will be around $6m.

Norway’s Biotech Industry Gets Stimulus Package but EuropaBio is Still Waiting

Norway’s biotech industry has been thrown a lifeline with the implementation of a stimulus package but EuropaBio is still waiting on an EU wide financial boost.

The Norwegian government has decided to pump in just under $300m to support the beleaguered biotech industry, which like its compatriots around the world has been struggling.

Oslo Cancer Cluster has welcomed the funding, saying it could save 50 per cent of the 25 companies it represents that are due to run out of cash in the next 12 to 18 months.

Kristin Halvorsen, Norway’s finance minister, said: “This is the most ambitious fiscal stimulus proposed in more than 30 years to boost growth and employment, and a strong stimulus also when compared with measures introduced in other countries.

“The measures are aimed at addressing the emerging problems in the Norwegian labor market. It is vital to ensure that the measures we implement are targeted, temporary and will contribute to sustainable growth.”

However, the rest of Europe, coffers less swelled with oil money, is still awaiting a stimulus package. A few days before Norway unveiled its plan EuropaBio called for the EU to implement an economic package that “rewards research excellence and stimulates innovation”.

EuropaBio is calling for the EU to be more coherent in its approach, particularly highlighting the fragmentation in the intellectual property regime, and to better coordinate funding.

The amount of money the life science sector received in the fourth quarter of 2008 fell by 33 per cent in comparison with the previous year, according to a report by PricewaterhouseCoopers (PwC) and the National Venture Capital Association (NVCA).

Funding for the year fell to $8bn, down from $9.3bn, with the biggest drop occurring in 4Q when recession fears properly took hold.

Despite these difficulties the report tries to maintain an upbeat tone, with Mark Heesen, president of the NVCA, saying the financial problems may create “a time ripe with opportunity”.

2009 Facility of the Year Awards (FOYA) Winners Announced

Six pharmaceutical manufacturing facilities constructed by companies located in Belgium, India, Ireland, Germany, and Switzerland have been selected as Category Winners in the fifth annual Facility of the Year Awards program sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. The companies and respective award categories include:

Aseptic Technologies, located in Gembloux, Belgium, winner of the Facility of the Year Award for Equipment Innovation
Centocor Biologics Ireland, located in Ringaskiddy, Cork, Ireland, winner of the Facility of the Year Award for Sustainability
Centocor R&D Schaffhausen, located in Schaffhausen, Switzerland, winner of the Facility of the Year Award for Facility Integration
Hameln Pharma, located in Hameln, Germany, winner of the Facility of the Year Award for Operational Excellence
Orchid Chemicals & Pharmaceuticals, located in Aurangabad, India, winner of the Facility of the Year Award for Regional Excellence
Roche Pharma Biotech Production Basel, located in Basel, Switzerland, winner of the Facility of the Year Award for Project Execution

In addition, GlaxoSmithKline Manufacturing was awarded an Honorable Mention for the company’s project in Verona, Italy.

The Facility of the Year Awards (FOYA) 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.

“We were truly impressed with the quality of this year’s submissions, as well as the depth and breadth of each organization’s innovative solutions for pharmaceutical manufacturing challenges,” said Robert P. Best, ISPE President and CEO. “It seems that each year the best and brightest minds in the industry raise the bar for quality, creativity, and ingenuity…which will ultimately benefit people worldwide,” said Best.

The Facility of the Year Awards program is truly global, as submissions over the past five years have been received from more than 20 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 Equipment Innovation: Aseptic Technologies

To address the incidents that are still recorded each year due to the injection of contaminated products, and the complexities of vial component preparation, high-speed stoppering, and aluminum cap crimping, Aseptic Technologies, a subsidiary of GlaxoSmithKline Biologicals, developed the new Crystal® Closed Vial technology for aseptic filling of injectable products. As this technology was completely new, Aseptic Technologies decided to install the first Crystal Closed Vial Filling Line (CVFL) in its own Gembloux, Belgium facility and operate it as a contract manufacturing organization to help clients obtain stability data and fill clinical batches before making large financial investments.

The site is located in the center of Europe, 60 km away from Brussels, the capital of Belgium and European Community. It is composed of two buildings: AT01 which is dedicated to offices meeting rooms and workshops and AT02 that includes workshop, offices and a filling suite of 400-square-meters with all of the necessary equipment to perform aseptic filling in the Crystal Closed Vial technology.

Facility of the Year Award Winner for Sustainability: Centocor Biologics Ireland

In 2001, Centocor started looking at options to provide additional manufacturing capacity for two promising new drugs in their pipeline. However, its existing manufacturing sites were built-out, so it was necessary to consider a greenfield site. In June 2004, after three years of study, Centocor approved funding to establish a new cell culture and purification site in Ringaskiddy, County Cork, Ireland. The overall mission of this project, dubbed BioCork, was to have 180kg-per-year biologic API capacity approved for market by June of 2010.

The BioCork team worked closely with local residents to mitigate the impact of this large, complex project on the community. The project provided traffic mitigation alternatives, utilized advanced membrane waste water treatment, captured rainwater for recycling, and installed a biomass (woodchip) boiler for base steam load. This project also involved extensive landscaping that included planting 70,000 trees to mitigate visual impact and air quality. BioCork is 40% more energy-efficient than internal benchmark biotech facilities and there was a 90% reduction in the carbon footprint versus fossil fuel. In addition, through careful preparation, communication, and implementation of safety planning, BioCork is one of the safest large projects ever built in Ireland.

Through use of integrated budgeting and scheduling, coupled with full user participation, this complex project was completed ahead of schedule, under budget, and exceeded capability requirements in all areas, most especially in the sustainability category.

Facility of the Year Award Winner for Facility Integration: Centocor R&D Schaffhausen

Several years ago, Centocor Research & Development recognized that it did not have the capacity or capabilities in its existing fill finish facility to meet the future needs of its expanding product pipeline. Subsequently, plans were developed to build a new 670 m2 fill finish pilot plant facility (F2P2) on its Schaffhausen, Switzerland campus. Centocor’s new F2P2 R&D fill finish plant replaces an older existing facility and offers a state-of-the-art technology portfolio that mirrors the set-up of commercial facilities to ease process comparability and scale-up. The facility produces biological drug product for early- and late-stage clinical trials and also plays a key role in the transfer of fill finish operations into a commercial plant, also located on the Schaffhausen campus.

F2P2 contributes significant advances to the pharmaceutical manufacturing industry by creating a unique solution for a multi-product, multi-format R&D clinical fill finish facility. The facility was strategically located within the Schaffhausen campus to take advantage of adjacencies for central utilities, quality unit offices, and analytical group. It has been well-integrated into the existing campus and has the possibility for expansion by adding floors above the existing structure. It also demonstrates the superior integration of facility and equipment designs that provide maximum flexibility with high levels of sterility assurance (RABS and VHP decontamination concept) and an efficient operation.

The facility was designed, built, and qualified in 30 months. It produced its first batch of drug product in March 2008.

Facility of the Year Award Winner for Operational Excellence: Hameln Pharma

Hameln Pharma’s new, 9200-square-meter sterile production plant, located at the headquarters of this 50-year-old, family-run business in Hamelin, Germany, was built to significantly increase production capacities in the area of parenteral contract manufacturing, create expansion possibilities for the company, and ensure reliable compliance with international regulatory standards.

Lean production concepts were consistently implemented throughout the design and construction of this facility. For example, the U-shaped structure of the filling systems reduces the footprint in the highest cleanroom class and increases productivity. The work areas within the sterile production plant were constructed using a materials flow simulation to prevent any form of waste of capacities, personnel and materials movement, resources, area or time. With the aid of integrated locks and hatches, materials are always transferred by the shortest route from one production step to the next.

The arrangement of the cleanroom classes to each other and a consistent lock design ensure that employees only need to cover short distances and go through as few clothing changes as possible, saving time and improving safety significantly. The consistent standardization of rooms, equipment, inventory, production resources and processes increases employee productivity and thus the efficiency of the entire production process since employees are able to continuously orient themselves and work in a quick and organized manner. A pharmaceutical cleanroom ceiling that is 100% accessible – meaning that it can be walked on everywhere – allows the exchange, installation, and maintenance of basic technical equipment, such as lamps and filter units, from above the ceiling, keeping production undisturbed.

The planning of this streamlined plant began in March 2006. Only 25 months later, Hameln was able to put a highly innovative and flexible sterile production facility into operation.

Facility of the Year Award Winner for Regional Excellence: Orchid Chemicals & Pharmaceuticals

To accommodate the growing number of development products and promote the application of new technologies, Orchid Chemicals & Pharmaceuticals created a new facility with modern and flexible cGMP aspects to manufacture internationally acceptable products. The Carbapenem Production Facility project is located in Aurangabad, India, 400 kilometers away from Mumbai and consists of four well-integrated production blocks (Intermediate/API/Sterile/Hydrogenation), with each block designed with dedicated service and production areas. All critical operations are contained in clean rooms, and advanced technical systems are used in all sections of manufacturing.

Orchid took several measures to conserve energy and reduce manufacturing costs during facility design, including the implementation of a horizontal scrubbing system that uses 30% less power than conventional scrubbing systems, as well as the installation of energy-efficient vacuum systems, a multi-stage evaporator, water-cooled refrigeration systems, and fluorescent lighting. In addition, they implemented automated systems for nitrogen blanketing for centrifuges, flash steam recovery, and secondary steam generation from evaporators to save energy. The team also implemented equipment designs that enabled significant reduction in cycle time, such as an ultrasonic crystallizer and agitated Nutsche Filter Dryer.

In addition, there are several aspects of this project that are unique and innovative for this geographic location. The Carbapenem Production Facility employs one of the first cGMP operational systems for bulk API handling in India. And not only was the high degree of facility automation critical for providing operational ease, improved safety and process integrity, and consistency in production, but it is also a completely novel concept in India.

In the end, Orchid successfully completed a sizable, fast-track project to meet market demand using a combination of innovative engineering concepts and state-of art equipment to produce quality products in a safe, consistent, and environmentally sound manner. Being able to successfully accomplish these goals, while dramatically increasing their productivity using all in-house expertise, was one of the major reasons for their selection as a Regional Excellence Category Winner.

Facility of the Year Award Winner for Project Execution: Roche Pharma Biotech Production Basel

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. Their Monoclonal Anti Bodies (MAB) 95 Facility was conceived to provide additional production capacity for the API of Avastin®, a successful new treatment medication used in the fight against cancer.

The primary business driver of this ultra fast-track project was to make this innovative product available to patients as quickly as possible. To do so, Roche expertly planned, designed, and constructed a unique vertical MAB facility on the site of a former chemical production plant in a busy residential area of Basel. By industry standards, the timelines were exceptional for a project of comparable size, complexity, and environmental sensitivity. Standing 40 meters tall with eight floors above ground and two floors underground, the small building footprint and absence of adjacent construction lay-down areas tested the ingenuity of the project team at every turn. (For example, the construction staff occupied a project office located on an elevated platform over the main public roadway.) To reduce congestion in and around the already tight project site, cutting-edge communication technology was applied whenever possible in the day-to-day running of the project. Extensive use was made of video conferencing, documentation was exchanged via the Internet prior to joint reviews, site access was restricted to key personnel, and all project participants were encouraged to conduct as much communication as possible through electronic media. As the facility had to be arranged vertically, and as all systems are fully integrated, the normal option of sequential completion proved to be too slow when modeled in the schedule. This forced the project team to develop the tactics necessary to complete the whole facility as a single entity (i.e., work on everything in parallel). The project team competently faced this and other project challenges with a “no blame, fix the problem” mentality.

Through teamwork, innovative design, and precise construction management, this state-of-the-art project was successfully realized in only 35 months, six weeks ahead of an already aggressive schedule and nine percent under budget.

Facility of the Year Award Honorable Mention: GlaxoSmithKline Manufacturing

GlaxoSmithKline’s Italian operations have been based in Verona, Italy since 1932 and the region has become a centre of excellence for the production of sterile cephalosporin powder products. Knowing that the greatest risk to sterile processes is the possibility of people contaminating the product, GSK decided to create the necessary conditions for its production process to take place without people being present in critical areas. Hence, GSK’s decision to revamp its Aseptic Powder Filling Facility 4 located in Verona.

The target of the project was to implement technological and operating solutions to assure, in the long-term, a state-of-the-art process suitable for the antibiotic business as an alternative to isolator technology. This approach included an innovative approach to equipment, environment, handling, and storage that is unique in the industry. GSK effectively created a template for aseptic powder filling and designed several elements specifically for this project to make the process reliable and repeatable.

The revamp of GSK’s Aseptic Powder Filling Facility 4 was completed in March 2007 and its main solutions to existing API challenges include in-line particle counting monitoring, increased line performances, enhanced protection of operators from API, performing routine operations using glove ports, Grade A continuity, the completion of semi-automatic set-up using glove ports, and pre-assembling product contact machine parts before sterilization.

2009 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:

· INTERPHEX2009– Meet the Category Award Winners at the Facility of the Year Awards Display Area at booth number 1059, Level 3 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.

· SPE 2009 Annual Meeting – Learn first-hand who the Overall Winner of the coveted 2009 Facility of the Year Award is during ISPE’s 2009 Annual Meeting, 8-11 November in San Diego, California, U.S.

· At each event, a Facility of the Year Awards display will feature the 2009 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.

McIlvaine Company,

Northfield, IL 60093-2743

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

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