PHARMACEUTICAL & BIOTECHNOLOGY

UPDATE

 

October 2009

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

UNITED STATES

 

APC’s New R&D Unit Plans for Sunnydale, CA

Bristol-Myers Squibb Plans 113 Job Cuts in Southern Indiana

Jackson Lab Eyes Expansion into Florida

Schott Plans 24/7 RTF Syringe Production at US Plant

Concordia University to Construct New Building for Genomics Research

Eli Lilly To Sell Manufacturing Plant to Evonik

Virginia BioInformatics Wins $28M for Pathogen Informatics Center

NIAID Awards $67.5 Million for Bioinformatics Resource Centers, But Cuts Number of Centers

American Peptide Company Adds Research And Development Group

SAFC Completes $12 Million Contract Manufacturing Facility Expansion in Carlsbad, CA

NuGen to Open Two New Facilities

Cardiovascular Systems Chooses Houston Suburb for Manufacturing

Specialty Silicone Fabricators Plan Manufacturing for Pasa Robles, California

Chinese Medical Device Firm, Huiheng, to Build Plant in Louisiana

Kavanagh Named Developer for Next Phase at Gateway Park

Indiana Redevelopment Commission Buys 845-Acre Site from Pfizer

LifeTech Initiative Lures Ginkgo BioWorks, Eutropics Pharma to Boston

Dow AgroSciences to Expand Into Purdue Research Park

Hanford Pharma Sells Manufacturing Facility in Syracuse

Three Life-Sci Shops Plan to Expand in Palm Beach County, FL

Ash Stevens Starts $6 Million Expansion in Michigan

MedPlast Has Cleanrooms in Tempe, AZ

Jackson Labs Get Money for Expansion

FDA Renews Lease in Piedmont-Owned Shady Grove V in Rockville, MD

Genentech Inks New South San Francisco Lease for 75K Sq. Ft.

Allegheny Bradford Expands Machinery Production with New Facility

Aushon Expands Facility to Meet Biomarker Service Demand

SUNY-Upstate Breaks Ground on Biotech Center

Ampac Bulks up API Capacity with 3 LLC Units

Medplast Upgrades Arizona Facility

Bayer Sets $100M Retooling of Berkeley, CA, Manufacturing Site

Genzyme Plans $68M Renovation for Northborough, MA, Set to Consolidate Framingham, Allston Operations

Maryland Biotechnology Center Opens Two Offices

Regeneron Pharmaceuticals Expanding in New York

Gerresheimer Invests in Plastics with Two New Plants

MA Life Sciences Approves $90M for Center at Worcester's UMass Medical School

Marine Biological Laboratory Breaks Ground on $25M Renovation of Loeb Laboratory

Michigan Life Science and Innovation Center Opens in Plymouth, MI, Ex-Pfizer Facility

Massachusetts College of Pharmacy and Health Sciences Opens New $10M Academic Center in Worcester

Buck Institute Working on Two Plans to Finance $41 Million Novato Campus

Advanced Electron Beams (AEB) Expands Aseptic Packing

 

REST OF THE WORLD

Siro Clinpharma Ramped Up Clinical Trial Manufacturing in Mumbai

Glaxo to Create UK Science Park

Merial Animal Health Invests $70 Million in Nanchang, China

Catalent Pharma Solutions German Facility Successfully Completes FDA Audit

US CRO Charles River Laboratories (CRL) Cuts Staff at Facility in Montreal, Canada

Charles River Shanghai Facility Gains Accreditations

GlaxoSmithKline Forms Joint Venture with Jiangsu

Ireland’s Almac Gets OK to Build on 5.4-Acre Parcel Near HQ

€14.8 Million Approved for New Systems Biology Ireland Research Center

Vetter Inaugurates its Ravensburg, Germany Site for Pharmaceutical Production

Patheon Opens New Pharmaceutical Development Services (PDS) Manufacturing in Italy

Quintiles Doubles Central Lab Capacity in Expanded Site near Edinburgh

Vancouver, BC, Biotech Firm Radient Consolidating Operations in Edmonton, Alb.

Sirona Biochem Stepping Up Drug Development after French Partner Opens State-of-the-Art Lab

GE Healthcare Invests $1 Billion for Lab in India

French BioMerieux Opening a New Facility at its Crapone, France Site

Nycomed Plans €75m Russian Plant; May up €4.5bn Bid for Solvay

West Pharmaceutical Services Opens New Injection-Molding Factory in Shanghai China

China Packaging Firm Reaps Rewards from Food Safety Law

 

 

 

UNITED STATES

 

APC’s New R&D Unit Plans for Sunnydale, CA

The American Peptide Company (APC) plans to set up an R&D unit at its facility in Sunnydale, California to better serve growing demand for innovative technologies.

 

The new unit, which will serve both industry and academia, will provide technologies including glycosylation and pegylation to “more effectively drive bioactive peptides identified as potential drug targets through the discovery and development.”

 

APC sales director Firuz Shakoori, who spoke with in-PharmaTechnologist at this year’s CPhI conference in Madrid, Spain, said it was formed to meet growing drug industry demand for larger and more complex peptides.

 

Shakoori said that customers will provide both the core peptide molecule as well as specific set of production parameters, with APC’s role being to make the compound as per those specifications.

 

He added that the unit can undertake multiple projects in discovery and early-stage development, explaining that because such work does not need to adhere to current good manufacturing practice guidelines (cGMP) APC can take a flexible approach.

 

In broader industry terms, Shakoori said that expansion of the peptide market is causing customers to seek out large-scale production capacity which, in turn, is driving competition among contractors and increasing the need for such firms to differentiate their services.

 

Bristol-Myers Squibb Plans 113 Job Cuts in Southern Indiana

Bristol-Myers Squibb Co. plans to close one of its Evansville, Indiana facilities and cut jobs at Mount Vernon plant.

 

The company says in a state filing that the actions will cost 79 people their jobs as it shuts down its Evansville quality control facility and 34 jobs from cutbacks at its site in nearby Mount Vernon.

 

The New York-based company said that all the job cuts would be made by the end of December.

 

Jackson Lab Eyes Expansion into Florida

Three years after forging the first of its relationships with business and political leaders in and around Naples, Fla., the Jackson Laboratory is considering the region as a possible site for a third facility that would house a new institute focused on personalized medicine.

 

"The community's outreach to the laboratory was certainly a factor" in the Jackson Lab's decision to study the feasibility of expanding into the Naples area, said Joyce Peterson, a spokeswoman for the genetics research institute.

 

"We hope to make the decision whether to proceed by summer 2010," Peterson added.

 

She said the goals of the new institute include applying whole genome sequencing and bioinformatics to discover the genetic basis of human disease and health; translating its research findings into treatments through collaborations with clinical practitioners, researchers, pharmaceutical and biotech companies, and "leading" medical institutions; providing tools and techniques to other researchers worldwide; and carrying out public education about personalized medicine.

 

Jackson Lab has drawn financial and other support in the three years since it first connected with the Naples Business Roundtable, whose members include local corporations and individual business and civic leaders. The research institute is one of three nonprofits that benefit from the Earl Morrall/NFL Alumni Celebrity Charity Golf Classic, held annually in Naples.

 

Naples is one of five regions in the US where Jackson Lab has chapters of its National Council, whose members have all donated at least $1,000 to, and served as advocates for, the research institute. In the fiscal year that ended May 31, 2008, according to its 2008 annual report, Jackson Lab received $9.3 million in private gifts and grants, up from $8.5 million the previous fiscal year — but private donations accounted for only about 6 percent of the laboratory's $160.2 million FY 2008 budget.

 

Another factor in Jackson Lab's interest in the Naples area, Peterson said, was Florida's ability during this decade to attract a half dozen research institutes — the result of more than $1 billion in state and local tax breaks. One of those institutes, the Burnham Institute for Medical Research, on Oct. 8 celebrated the grand opening of its new $85 million, 175,000-square-foot building within the 600-acre 'Medical City' at the Lake Nona mixed-use, master-planned community in Orlando.

 

If the Jackson Lab proceeds with expansion to the Naples area, or somewhere else, it would be the genetics research institute's third location. Jackson Lab now bases some 1,300 staffers at its 160-acre Bar Harbor, Maine, campus, which adjoins Acadia National Park, and about another 90 people at its 85,000-square-foot Jackson Laboratory-West facility in Sacramento, Calif., which officially opened in May following a $40 million renovation.

 

The Maine workforce shrunk this past spring, when Jackson Lab laid off 55 employees and cut the hours of 315 hourly workers, citing the economy. But by August, the full schedules of hourly workers was restored, with Jackson's Chief Operating Officer Charles Hewett telling the Bangor Daily News he was able to do so in part because of a 7 percent year-over-year jump since June in revenue tied to its breeding of mice for other labs worldwide.

 

On Aug. 5, the research center broke ground on a three-story, 22,500-square-foot research building in Maine that will house a new importation and isolation facility, including a receiving center for mouse models from other research institutions. The existing facility will be converted into additional R&D space. Construction is set to be completed in November 2010, with operation to begin the following spring.

The new building's first construction phase is being funded with $4.7 million from the $50 million Maine Technology Asset Fund, a competitive award program funded by bonds approved by state voters in 2007, and run by the state-funded private nonprofit group Maine Technology Institute.

 

In addition, last month, Jackson Lab won $2.1 million in funds from the $787 billion American Recovery and Reinvestment Act toward expanding its computational facility and growing its staff over the next five years. The laboratory will grow from 38 research groups to 45 over the next four to five years, Peterson said.

 

"Although we are considering a new branch in Florida, our core operations will stay in Maine," Jackson Lab President and CEO Rick Woychik said in Jackson Lab's Oct. 14 statement announcing its feasibility study of a "southwest Florida" site.

 

"We want to assure our employees, friends, and neighbors that any expansion will be designed to complement our existing scientific capabilities here," he said. "We will maintain and grow our existing programs and facilities in Maine and California."

 

Schott Plans 24/7 RTF Syringe Production at US Plant

The US arm of packaging giant Schott has added ready-to-fill (RTF) glass syringe manufacturing capacity at its facility in Lebanon, Pennsylvania in a $14m (€9.4m) expansion designed to meet growing demand.

 

Schott predicted that North American demand for RTF manufacturing will increase eight to 10 per cent a year, driven by the growth of key therapeutic markets for diseases like diabetes and cancer.

 

The firm, which already manufactures vials, ampoules and cartridges at the Lebanon plant, said it will produce up to 270,000 RTF syringes a day when fully operational and added that it will create 40 new jobs over the next 12 months.

Schott plans to begin round-the-clock production in the next two years and added that a further $30m will be invested to boost manufacturing capacity at the site.

 

Concordia University to Construct New Building for Genomics Research

Judith Woodsworth, President and Vice-Chancellor of Concordia University is pleased to announce the construction of a new building for the Centre for Structural and Functional Genomics (CSFG). The Centre will be built thanks to a grant of $29,345,427 from the Federal and Provincial Governments through the Knowledge Infrastructure Program.

 

The Genomics Centre will house cutting-edge biotechnology and bioinformatics laboratories for interdisciplinary research in genomics and systems biology. In addition to advanced research in cellular and molecular sciences, the Centre supports fundamental and applied research in crop improvement and sustainable biotechnology. Current large-scale projects in biomass conversion, cellulosic biofuels, alternative energy sources and bioproducts aim to develop new cost-effective and environmentally-benign biotechnologies to help secure Canada's future bioeconomy that will be grounded on sustainable development principles.

 

The plan is to expand the Richard J. Renaud Science Complex on the Loyola Campus (7141 Sherbrooke St. West). The Genomics Centre would then be housed in a new wing, measuring 5,400 m2 ( 58,104 sq. ft.). The Centre will support the research programs of its members, their graduate students, post doctoral fellows and research professors drawn from the science and computer science departments at Concordia, and will be accessible to all researchers at Concordia and the external research community who are interested in using its unique infrastructure and knowledge base. The layout of the new laboratories will encourage the cross-disciplinary interactions needed to fully exploit the power of genomics-based research and systems biology.

 

Work on the Centre is scheduled to begin early in 2010 and completed in the spring of 2011.

 

Eli Lilly To Sell Manufacturing Plant to Evonik

Eli Lilly & Co. is selling a central Indiana manufacturing plant where about 700 people work to a German chemical company.

 

The Indianapolis-based drugmaker announced that Evonik Industries AG would take over the Tippecanoe Laboratories near Lafayette by the end of this year. Lilly says that the plant's workers will all be offered jobs with Evonik, which will make ingredients for some Lilly drugs under a nine-year contract.

 

Lilly says it expected its use of the Lafayette facility to decline because patents on some drugs made there will expire soon. The plant had about 1,000 employees before Lilly offered buy-out packages to 250 workers in 2007.

 

Lilly said last month it planned to eliminate 5,500 jobs by the end of 2011.

 

Virginia BioInformatics Wins $28M for Pathogen Informatics Center

The National Institute of Allergy and Infectious Diseases has granted $67.5 million to fund four Bioinformatics Research Centers, including a $27.7 million grant to the Virginia Tech that will support pathogen studies.

 

On top of the $27.7 million granted to Virginia Tech's Virginia Bioinformatics Institute, the BCR funding also was awarded to Northrup Grumman Information Technology, the University of Notre Dame, and the University of Pennsylvania.

 

The BRC funding will go to integrate information on pathogens, support scientists in their research, and help them analyze genomic, proteomic, and the other data that their research generates.

 

At VBI, the grant will specifically support the CyberInfrastructure Group, which has led its own BRC over the past five years and has worked with others around the country, according to CIG Director Bruno Sobral, who is a principal investigator on the project.

 

The BRC grant will fund the CIG's pathogen studies and efforts over the next five years.

 

"As we move ahead, we will be working hand-in-hand with a wide range of partners, including medical schools and public health institutions interested in translating the very latest scientific discoveries and innovation into practical health benefits for society at large," said Sobral.

 

The overall program will include the four centers and a new gateway portal for the entire project, which CIG will develop.

 

Each BRC will focus on one type of pathogen, including bacterial species, viral families, protozoan species, and invertebrate vectors of human pathogens.

 

NIAID Awards $67.5 Million for Bioinformatics Resource Centers, But Cuts Number of Centers

The National Institute of Allergy and Infectious Diseases has awarded $67.5 million over five years to four Bioinformatics Resource Centers for Infectious Diseases, which collect, annotate, and host genomic, proteomic, and metabolic information and datasets, and offer analysis and visualization tools to study pathogens.

 

The grants, which renewed BRCs at Northrop Grumman Information Technology, the University of Notre Dame, the University of Pennsylvania, and Virginia Polytechnic and State University, cut the total number of centers to four from eight.

 

BRCs led by SRA International, the University of Chicago, the J. Craig Venter Institute, and the University of Alabama, Birmingham, will not have their funding renewed in the current round of grants.

 

NIAID initially launched the BRCs in 2004 in funding in an effort to provide bioinformatics support for researchers studying organisms classified as Category A, B, or C pathogens. There were five centers awarded under the initial funding, and the number of BRCs was increased to eight a year later, with total funding of $88 million for the eight centers.

 

The BRCs are intended to be public repositories of genomics and related data generated by NIAID-supported genomics research and contracts as well as publicly available data generated by the scientific community.

 

According to NIAID's solicitation for the program, the grant continues funding for some of the BRCs and involves "expansion" of the effort to include collaboration on experimental research projects to "apply bioinformatics techniques to investigate and support experimental biology research" in infectious diseases.

 

One of the BRCs will be charged with maintaining a central BRC portal, launched in 2005, to make available analytical resources and bioinformatics services along with genomics data and other research data on infectious diseases caused by human pathogens.

 

The awards are welcome news for the institutions whose grants were renewed, but the others will either cease support for certain resources or transfer their data and tools to the funded centers.

 

The grant to the University of Pennsylvania, for $14.6 million, will continue to support the work of biologist David Roos and his team and also supports the Eukaryotic Pathogens Database, which holds information, tools, and datasets on organisms such as Giardia, Leishmania, and Toxoplasma.

 

The award to the University of Notre Dame, for $12.2 million, supports biologist Frank Collins and a team of researchers to support VectorBase, which includes information and tools on arthropod vectors of human pathogens.

 

Virginia Tech was awarded $27.7 million to continue to support the Pathosystems Resource Integration Center, or PATRIC. The resource hosts information and comparative genomics tools about bacteria such as Brucella and viruses such as the hepatitis A and E viruses and Lyssavirus.

 

Northrup Grumman was awarded $13 million under the current round of grants, though it is unclear which of the databases it will support. Northrup Grumman had previously developed BioHealthbase — which focuses on the influenza virus, Mycobacterium tuberculosis, and Francisella tularensis — along with the University of Texas Southwestern Medical Center; Vecna Technologies; and Amar International. However, BioHealthBase has posted a note on its website stating that itsBRC contract ends in December, "at which time the BioHealthBase resource will cease to exist."

 

According to the website, support of Ricinus communis, a plant from which the protein toxin ricin is extracted, "will be discontinued," while the PATRIC team will support all pathogenic bacteria, including Mycobacterium and Francisella."

 

As for the other BRC grants that were not renewed, the J. Craig Venter Institute had hosted Pathema, which focused on pathogens such as on B. anthracis and Clostridium botulinum.

 

Earlier this year, NIAID funded JCVI with $43 million for five years as one of the Genomic Sequencing Centers for Infectious Diseases.

 

Another BRC to not get renewed was the Enteropathogen Resource Integration Center, led by SRA International and the University of Wisconsin, Madison, which was devoted to information on the bacterial family Enterobacteriaceae, including Shigella, Salmonella and Yersinia pestis.

 

In addition, the National Microbial Pathogen Data Resource Center, run by the University of Chicago; the Fellowship for Interpretation of Genomes; and the University of Illinois Urbana-Champaign, was not renewed. Nor was the Viral Bioinformatics Resource Center, led by the University of Alabama Birmingham; and Canada's University of Victoria.

 

It was not immediately clear how or whether NIAID plans to continue support for the pathogens in the Pathema, ERIC, NMPDRC, and VBRC

 

American Peptide Company Adds Research And Development Group

American Peptide Company, a provider of peptide manufacturing and peptide-based services, has announced the formation of a new research and development group. Created to offer more robust technology capabilities to a growing roster of global pharmaceutical and biotech customers, the R&D group will be based at the company’s Sunnyvale, California facility and will be tasked with the development of innovative new products and services.

 

Peptide drugs are rapidly increasing in complexity, now requiring challenging modifications, incorporating unnatural amino acids, and being linked to carrier molecules to enhance drug delivery efficacy. Designed for indications to treat ailments such as diabetes, HIV, neurological disorders like Alzheimer’s disease, cardiovascular diseases, and cancer, peptides have tremendous therapeutic potential, but can be difficult to synthesize to the high quality necessary for research and commercial production. American Peptide Company has instituted the R&D group to help meet this industry need and provide peptide solutions to the drug development community.

 

“The new R&D group will better enable American Peptide Company to meet the complex and evolving needs of our global customer base,” says Takahiro Ogata, President & COO of American Peptide Company. “This initiative fits well with our broader company mission to provide Total Peptide Management solutions to drug researchers and developers pioneering solutions for improving human life. The R&D group and the technological capabilities they offer will ultimately help our customers more effectively drive bioactive peptides identified as potential drug targets through the discovery and development phase.”

 

The R&D group also helps drive American Peptide Company’s focus on manufacturing complex peptides. Monosaccharide, disaccharide, and polysaccharide peptide conjugations, multiple disulfide bridges, phosphorylated and biotinylated structures, are among the specialized capabilities the company offers.

 

SAFC Completes $12 Million Contract Manufacturing Facility Expansion in Carlsbad, CA

AFC Pharma®, a business segment of SAFC®, a member of the Sigma-Aldrich® Group has announced the completion of an addition to its Carlsbad, Calif., facility that expands the Company's contract manufacturing services for its late phase and commercial clients. The $12 million project includes the addition of two fully segregated state-of-the-art viral product manufacturing suites, built to employ the latest in disposable bioreactor technologies, expanding SAFC Pharma's biologics, viral vaccines and gene therapy manufacturing to commercial-scale quantities.

 

SAFC Pharma's Carlsbad site specializes in the process development and manufacturing of viral vaccines and viral therapeutics, including a full menu of support services, from preclinical process and analytical development to final fill/finish and commercial bulk drug supplies. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. Adding 8,000 sq. ft. of manufacturing space to the existing 44,000 sq. ft. site, the addition enables both 100-liter batch production in stirred tank bioreactors and 1,000-liter batch manufacturing in disposable bioreactors, and is Biosafety Level 2 compliant, allowing manipulation of human pathogens. Designed from the outset as a containment facility, the expansion space allows clients to secure a dedicated suite of cleanrooms for larger scale manufacturing.

 

"We are delighted to announce this expansion of our capabilities at our Carlsbad facility, particularly when the economic environment has been so challenging," commented David Feldker, Vice President SAFC Pharma. "We expect to see a great deal of value in the biologics and viral manufacturing marketplace in the next three to five years generated by two main customer types - those with late clinical phase opportunities but without any in-house manufacturing capability and those with late clinical phase opportunities that have some manufacturing capabilities but may be seeking an additional 'safety net' or wish to avoid additional capital expansion until their technology and drug has proven itself. By adding and extending our capabilities at Carlsbad, we are providing customers with an attractive, clear pathway that adds value and supports secure, successful product launches."

 

"The expansion at our Carlsbad campus underlines SAFC's strategy to continue to invest in building world class capabilities that serve and enhance our leadership in important emerging new technologies such as niche biologics production and viral manufacturing - areas where we see great potential and traction," added SAFC President Gilles Cottier. "Our investment in large capacity manufacturing, our financial stability, experience and quality systems differentiates us in the market and enhances our abilities to securely support our customers all the way to successful product launch."

 

Facility validation studies are currently underway, with an expected start of cGMP manufacturing operations by the end of December 2009. The site added numerous utility support systems to allow for continuous operation and will now utilize its new Water For Injection (WFI) system. The Company has enjoyed a close relationship with a number of clients developing an exciting array of cancer therapeutics, gene therapies and mammalian and insect cell-based viral vaccines.

 

SAFC has announced worldwide investments totaling $90 million in the past two years to expand capacity for active pharmaceutical ingredients (API) production and biologic drug products. These investments build on the Company's strengths in complex emerging technologies such as high potency manufacturing and viral vaccines manufacturing, further expanding its capabilities to serve customers in these growing areas. The expansion in Carlsbad follows the acquisition in 2007 of Molecular Medicine BioServices, Inc.

 

NuGen to Open Two New Facilities

NuGen Technologies plans to open two new facilities in November. The plans include a move from an existing facility in San Carlos, Calif., into a larger one, and a new research facility in Seattle.

The genomic sample prep company said today that the new facilities are part of its plan to launch a simplified sample preparation kit aimed at the next-generation RNA sequencing markets. NuGen said its expected product launch will offer researchers "the ability to convert a broader range of material types into sequencing libraries while streamlining sample preparation workflow."

 

"Our commercial success to date allows us to make a significant investment in establishing a strong presence in the high-growth NGS market," Elizabeth Hutt, NuGen's CEO, said in a statement. "Part of that investment is the recruitment of a team of new scientists, led by Dr. Christopher Raymond, formerly of Rosetta Inpharmatics."

 

Cardiovascular Systems Chooses Houston Suburb for Manufacturing

Pearland has beat out 200 communities in 13 states for development of a new medical device manufacturing plant for a Minnesota-based company.

 

Cardiovascular Systems Inc. signed a 10-year lease for a 46,000-square-foot manufacturing facility in Pearland that will be up and running by April 2010. St. Paul-based CSI — which is publicly traded on the Nasdaq exchange — expects to hire 250 local employees over the next five years to work at the site.

 

The Pearland Economic Development Corp. committed $6.25 million in current and future financial incentives to attract CSI to the area. The Pearland EDC paid the firm $3.5 million last month when the long-term lease was executed, and it will pay out another $2.75 million as certain employment milestones are reached. As employee numbers grow, the firm will also receive $600,000 from the Texas Enterprise Fund.

 

And for the first time ever, the Pearland EDC is taking on the role of developer and landlord as part of bringing CSI to the Houston area.

 

The entity invested $2.2 million to acquire 10 acres for the project earlier this year, before the deal was consummated. It is also spending $7.5 million to build the manufacturing facility, which includes 7,000 square feet of cleanroom space.

 

Fred Welch, executive director of Pearland EDC, says CSI was in a hurry to find space, and no suitable buildings were available in Pearland. He says having a traditional developer build a facility for CSI wasn’t an option because developers are having so much trouble getting financing for new construction, so the organization had no other alternative but to develop the facility itself.

 

Robert Thatcher, a CSI executive vice president, says Pearland and Fort Myers, Fla., were the final two cities in the running for the project. The company also conducted site visits in Waco and Abilene as well as Tallahassee, Fla.

 

Fort Myers’ financial package was similar to Pearland’s, but it could not build a facility in time for an April opening, Thatcher says.

 

Pearland EDC had been saving money for five years to attract businesses to The Spectrum at Clear Creek. The Spectrum is a 900-acre area at the southwest corner of State Highway 288 and Beltway 8 that’s zoned and branded for high-tech companies, office buildings and the retail/service businesses to support them.

 

Bass Pro Shops is the only business located in The Spectrum thus far. A shopping mall that was proposed to be built next to the store was never executed.

 

CSI is the first manufacturing company to commit to The Spectrum, which is controlled by multiple landowners.

 

CSI manufacturers the Diamondback 360° PAD System, a minimally invasive catheter for treating peripheral arterial disease.

 

Since receiving regulatory approval two years ago, nearly 600 hospitals across the United States have adopted the system, and more than 15,000 procedures have been performed using the product.

 

For the fiscal year ended June 30, 2009, CSI’s revenue rose to $15.7 million, a 59 percent increase over the previous year. The 230-person company expects to grow revenue by another 30 percent by June 30, 2010.

 

CSI is already manufacturing the Diamondback 360° PAD System in St. Paul, but needs additional manufacturing space.

 

CSI will begin hiring for the Pearland facility in December or January. The top local executive will even be hired locally. The firm will fill a full range of manufacturing positions, including plant managers, quality engineers, manufacturing engineers, manufacturing support, operators and assemblers.

 

Thatcher says the Pearland location could eventually grow to be larger than the corporate site in Minneapolis, and could house additional functions such as research and development in the future.

 

The 10-acre site owned by the Pearland EDC has enough room for another 34,000-square-foot facility as well as a 55,000-square-foot building.

 

“I fully anticipate there will be a second expansion there,” Welch says, “and probably a third.”

 

Thatcher says another reason Pearland was selected from among the 200 interested communities is because of its proximity to the Texas Medical Center, and the fact that it’s less than three hours on a direct flight to St. Paul.

 

Specialty Silicone Fabricators Plan Manufacturing for Pasa Robles, California

Specialty Silicone Fabricators Inc. plans to construct a 100,000-square-foot. manufacturing plant in Paso Robles to meet growing demand within its silicone medical components business.

 

The company will break ground on the building in October, with completion slated for September 2010. The investment for the project was not disclosed.

 

SSF decided to build the facility because it needed the additional space to handle rising volumes of work and to house some new services, said Paul Mazelin, marketing manager for the company and its parent, Issac Medical Cos. The finished project will double the manufacturing space at SSF’s Paso Robles complex, which comprises three buildings spanning about 68,000 square feet.

 

One of the buildings will be torn down to make room for the new plant, while the other two will be used for some higher volume, longer-term projects, Mazelin said. The cleanrooms there will remain and manufacturing cells will be constructed where needed.

 

The new facility will house a 38,000-square-foot ISO Class 7 (Class 10,000) cleanroom, as well as company offices and other departments. The clean room area will add flexibility and allow SSF to build manufacturing cells and streamline its operations, he said.

 

The expansion also will help greatly in some new areas the company is entering, Mazelin said.

For example, SSF recently received its drug manufacturing license, he said. That allows the company to procure active pharmaceutical ingredients to mix with selected silicone rubbers.

 

Ultimately, the firm will be producing combination products or implants that fill a niche for specific targeted therapy in discrete locations in the body. SSF sees the segment “poised for dynamic growth and opportunities,” he said.

 

The company also is beginning to extrude silicone-urethane hybrid materials, so there will be requirements in the plant for additional thermoplastic extrusion lines, Mazelin said.

 

The expansion continues the growth mode SSF has been in this year. In February, SSF announced it added and installed two automated injection molding machines for small parts in Paso Robles, bringing the number of presses at the site to 35.

 

The firm will continue to add equipment as needed, Mazelin said, but the manufacturing space created by the new building will make a difference.

 

“To meet the demands of the future, we must modernize and expand,” said SSF President Kevin Meyer.  “While other companies often move to lower-wage countries to expand, we must recognize the value of the knowledge, experience and creativity of our employees, and therefore plan on remaining a Paso Robles-based technology company,” he said.

 

Nearly all of SSF’s business is in the medical sector, providing silicone fabrication for device makers via several manufacturing disciplines, including molding, extrusion, calendering/sheeting and dipping, Mazelin said. Molding makes up about 40 percent of the company’s revenues.

 

The company makes silicone components for a variety of devices, including hydrocephalus shunts and pacemaker leads, plus an instrument that holds the beating heart in place during surgery.

 

SSF employs about 200 at its site in Paso Robles and its 40,000-square-foot satellite plant in Elk Rapids, Mich.

 

Parent company Issac Medical also owns Innovative Surgical Products Inc, which specializes in medical assembly and packaging and employs 100. Both Issac and ISP are based in Tustin, Calif.

 

Chinese Medical Device Firm, Huiheng, to Build Plant in Louisiana

A Chinese company plans to build a plant in Baton Rouge, LA, to manufacturer a radiation treatment device.

 

Huiheng Medical Inc. would employ up to 300 people at salaries of up to $75,000 if the Food and Drug Administration approves the device, the company's chief executive, Xiaobing Hui said.

 

Huiheng said it is also applying for a U.S. patent for the device, which is already used in many hospitals worldwide to treat cancer patients. Ji said the cancer-treatment devices are now assembled in China from components made in that country, as well as Europe, Asia and the United States.

 

Huiheng wants to build a plant in Baton Rouge in part because of the expertise available in the area, Ji said. The company also hopes to capitalize on the LSU medical physics program, which trains students in the use of the use of radiation systems for cancer treatment, Ji said.

 

Huiheng would also like to do clinical research trials for the device with Mary Bird Perkins Cancer Center.

 

Mary Bird spokeswoman Amy Benton said the center has invested millions of dollars in devices made by two other companies and has research partnerships with both firms.

 

The company was approached by Holden during his economic development trip to China in April. Ji said 13 other Chinese companies plan to visit Baton Rouge through 2010.

 

Kavanagh Named Developer for Next Phase at Gateway Park

The Kavanagh Advisory Group (KAG) of Danvers, a development firm with significant experience building life sciences facilities in Boston's Longwood Medical Area and Kendall Square in Cambridge, has been selected to develop the next phase of Gateway Park and has signed a letter of intent to do so.  The agreement gives KAG the opportunity to develop up to four buildings at Gateway Park, which is a mixed-use, master-planned campus in downtown Worcester with a primary focus on life sciences.

 

"We are pleased that a firm with the proven track record and life sciences development expertise of the Kavanagh Advisory Group will join us in the next stage of development of Gateway Park," said Dennis D. Berkey, president and CEO of Worcester Polytechnic Institute (WPI). "The firm clearly recognizes the potential for growth in the life sciences in Worcester and Central Massachusetts."  WPI launched Gateway Park in partnership with the Worcester Business Development Corporation (WBDC). 

 

The designation of KAG as the developer for the next phase of the park gives the firm the freedom to operate on the site, and to continue negotiating with potential tenants for new buildings. KAG is already at work securing the financing and other commitments that will be required for construction to move forward. KAG is currently in the design phase for the first building it plans to construct at the park, an 80,000 square-foot state-of-the-art wet lab facility.

 

"Gateway Park is an environment where academic, research and commercial enterprises thrive together," said John Kavanagh, founder and principal of KAG. "We see strong potential for additional growth at Gateway Park, and we look forward to moving quickly in hopes of breaking ground on a new building this year."

 

The first complex at Gateway Park, WPI's Life Sciences and Bioengineering Center (LSBC), opened in 2007 and is fully occupied. The $50 million, 125,000 square-foot facility is home to a mix of academic and commercial entities including graduate research programs in biology and biotechnology, chemistry and biochemistry, biomedical engineering, physics, mathematical sciences and chemical engineering. The LSBC contains several advanced research core facilities and a bioprocessing laboratory, which are available for contracted services and workforce training. Also located in the LSBC is Massachusetts Biomedical Initiatives (MBI), a world-renowned life sciences incubator facility that houses several start-up companies. Other growing companies at the LSBC include: Blue Sky Biotech, a contract research organization; CellThera, a biotechnology firm conducting tissue regeneration research funded by the U.S. Defense Advanced Research Projects Agency (DARPA); and RXi Pharmaceuticals, a company co-founded by Nobel Laureate Craig Mello to develop RNAi-based therapeutics.

 

Indiana Redevelopment Commission Buys 845-Acre Site from Pfizer

The Terre Haute Economic Development Corporation in Indiana said the Vigo County Redevelopment Commission has acquired three parcels at the Pfizer Terre Haute site.

 

The parcels, which include manufacturing, packaging, laboratory, warehouse, and office facilities, comprise 383,000 square feet of manufacturing facilities on 845 acres. They are adjacent to the 1,500-acre Vigo County Industrial Park.

 

The Terre Haute Economic Development Corporation will market the site on behalf of the Vigo County Redevelopment Commission to a “wide variety” of industries including life sciences.

 

LifeTech Initiative Lures Ginkgo BioWorks, Eutropics Pharma to Boston

Ginkgo BioWorks and Eutropics Pharmaceuticals have moved to Boston, lured in part by the city’s LifeTech initiative, created in 2004 to attract life-sciences firms to the city through low-interest loans, site location, and permitting.

 

Ginkgo BioWorks, a synthetic biology firm developed by five MIT researchers, received a $150,000 LifeTech Innovation Fund loan from the Boston Local Development Corp. Its new digs are in a 3,400-square-foot lab located in the Marine Industrial Park on the South Boston Waterfront.

 

Meantime, Eutropics, a blood cancer-treatment firm launched out of Harvard Medical School, Dana Farber Cancer Institute, and MIT, moved from Woburn to a 1,500-square-foot site at BioSquare, the Boston University Medical Campus. There it plans to add new staff to its five-person team, according to a statement reported by local media.

 

Dow AgroSciences to Expand Into Purdue Research Park

Dow AgroSciences announced that it plans to expand its Indiana research operations to Purdue Research Park.

The ag-bio company said it plans to partner with Purdue Research Park to “formalize a new research partnership.” In cooperation with the Indiana Economic Development Corporation, the Purdue Research Foundation will build a 6,000-square-foot greenhouse complex and lease 15,000 square feet of research and office space in the newly built Herman and Heddy Kurz Purdue Technology Center.

 

As part of the move, the IEDC will issue a grant of an undisclosed amount to help the Purdue Research Foundation construct the $2.2 million greenhouse research center.

 

Dow AgroSciences, which develops technologies used for crop protection, pest and vegetation management, seeds, and agricultural biotechnology, said it “plans to begin hiring scientists to support the research partnership starting this year.”

 

Hanford Pharma Sells Manufacturing Facility in Syracuse

Hanford Pharmaceuticals said it has completed the sale of a manufacturing facility in Syracuse, NY, for an undisclosed sum.

 

The facility, which manufactures the antibiotic cephalosporin, has been “an asset that had been under-performing for quite some time,” the firm said in a statement.

 

According to a local news report, Hanford plans to use the money from the sale to “redevelop” an 84,000-square-foot building it leases in nearby Clay, NY, into a manufacturing warehouse and laboratory for making clinical trial quantities of drugs for other companies.

 

Three Life-Sci Shops Plan to Expand in Palm Beach County, FL

Three life-science companies plan to expand in Palm Beach County, Fla., according to the county’s Business Development Board.

 

The companies are TMS Health, a healthcare communications company; BioCatalyst, which specializes in assisting biotechnology startups in bringing their products to market; and Strox Biopharmaceuticals, which is developing products for treating and preventing Staphylococcus infections.

 

The moves are expected to add $4.85 million to the local treasury and create 261 jobs, according to the board.

 

Ash Stevens Starts $6 Million Expansion in Michigan

Buoyed by an increase in repeat business and deals with large pharma companies Ash Stevens has begun a $6m (€4.1m) expansion of its API manufacturing facility, with further phases planned to occur over the next six years.

 

James Hamby, vice president of business development at Ash Stevens, explained that the company has had growing demand for active pharmaceutical ingredients (API) and record results in its past three fiscal years, prompting it to expand.

 

The new infrastructure, which is completely self-financed, includes a reactor bay. This will be similar to its existing reactor bay, and act as a backup, but will also include a 50 gallon hydrogenation vessel.

 

Hamby expects the first phase of the expansion to be operational in January. The second phase of the expansion will be complete in June 2010, when Hamby expects Ash Stevens to finish its new 10,000 sq. ft. warehouse.

 

These two developments will use the $6m Ash Stevens has ringfenced for expansion but the company has plans beyond this. If future business is strong Ash Stevens intends to further expand its site in Riverview, Michigan over the next six years.

 

The next step after the warehouse is the installation of larger vessels, up to 1,000 gallons, followed by process development capacity and highly potent API (HPAPI) handling capabilities.

 

Ash Stevens has been able to meet or exceed its five to 10 per cent annual growth target despite the economic downturn and this has prompted it to expand, according to Hamby.

 

He added that the company has benefited from increased business from large pharmaceutical companies, which Hamby believes are increasingly outsourcing their API operations.

 

Ash Stevens has also benefited from an increase in repeat business, an area Hamby said has always been strong at the company. Hamby attributes this increase to clients’ desire to outsource to companies that deliver quality and on-time, with cost being less important than these factors.

 

Upturns in these areas have compensated for reduced business from startup companies, which have struggled to obtain funding in recent quarters because of the economic situation.

 

MedPlast Has Cleanrooms in Tempe, AZ

MedPlast recently completed an expansion of its 50,000-sq-ft Tempe, AZ, facility. The upgraded plant now includes two Class 100,000 (ISO Class 8) cleanrooms that house injection molding and automated assembly operations.

 

Jackson Labs Get Money for Expansion

The Jackson Laboratory in Bar Harbor, Me., has won a $2.1 million American Recovery and Reinvestment Act grant from the National Institutes of Health.

 

The lab plans to use the stimulus funds from the National Center for Research Resources to buy new computing hardware and to add new lab space to accommodate an expected increase in its bioinformatics and computational biology staff.

 

A not-for-profit lab, the Jackson Lab is focused on studying the genetic basis for preventing, treating, and curing diseases, and is using bioinformatics and computational biology to develop and use genetic data.

 

Jackson Lab said that the new grant brings its total stimulus funding to $5.8 million, including grants for cancer, diabetes, HDL cholesterol, and neurological diseases.

 

FDA Renews Lease in Piedmont-Owned Shady Grove V in Rockville, MD

The US Food & Drug Administration has renewed for a five-year term its lease for 108,518 square feet within Shady Grove V, at 9200 Corporate Blvd in Rockville, Md. The four-story building, within the Shady Grove Executive Center, is home to the FDA's Center for Devices and Radiological Health's Office of Device Evaluation.

 

Genentech Inks New South San Francisco Lease for 75K Sq. Ft.

Genentech has signed a lease for 75,000 square feet on four floors at 601 Gateway Blvd., a South San Francisco, Calif., building known as Gateway Commons and owned by Boston Properties, CoStar Group reported. The lease will commence in the first quarter of next year.

 

Gateway Commons is a 12-story, 215,767-square-foot, Class A office property built in 1984 on 7.24 acres. Tom Hayes of NAI BT Commercial represented Genentech, while Gregg Walker, Scott Miller and Sharon Chen of Jones Lang LaSalle represented Boston Properties.

 

Allegheny Bradford Expands Machinery Production with New Facility

Allegheny Bradford of Lewis Run, Pa., has opened an $8 million, 50,000-square-foot manufacturing facility designed to double the company's capacity for production of pharmaceutical and biotech machinery, especially with tanks and modular process systems, or "skids" used in the production of drugs. Before building the roughly $8 million facility, the company produced the machinery at a smaller scale at a smaller plant which is being retained.

 

Allegheny Bradford moved into the new facility last December, but needed until February to receive its equipment for the facility. "We've been truly on line and in production for four or five months," Dan McCune, president and chief executive officer of Allegheny Bradford, told the Bradford (Pa.) Era. "It's our intention to add in the neighborhood of 100 jobs over the next couple years."

 

"We were limited in the tank market and modular process systems market because of a lack of space. Here we can better take advantage of those markets," McCune told the newspaper.

 

McCune told the Era Allegheny Bradford started planning for the warehouse facility in 2007 due to growing demand from customers: "This has been a couple-year process."

 

The new facility, he added, allows manufacturers to test equipment on-site before shipping, which is important because international customers make up roughly 50 percent of sales, McCune said.

 

Aushon Expands Facility to Meet Biomarker Service Demand

Aushon BioSystems has added laboratory and manufacturing capacity to its corporate headquarters to meet rising demand from clinical trials for some of its protein biomarker services.

 

The company reports that there has been strong demand for its multiplex immunoassays products and services, which it claims can detect low quantities of proteins, adding that it maintains its belief in the potential of the protein biomarker business.

 

Consequently a focus of the expansion of the Billerica, Massachusetts, US facility has been doubling multiplex immunoassay manufacturing capacity. The new operations are increasingly automated to improve throughput and reduce variability of a number of production processes.

 

Furthermore, the expansion and renovation of the headquarters has allowed Aushon to consolidate the operations of the recently acquired Searchlight at the facility.

 

Peter Honkanen, CEO of Aushon, believes this “allows [the company] to work more efficiently, encourages collaboration and innovation, and takes advantage of the inherent synergies that inspired Aushon to acquire the SearchLight business and technology assets”.

 

From the expanded facility, which houses a BL-2 level laboratory and clean and cold rooms, Aushon will offer a range of products and services for biomarker discovery, development and analysis. These include a protein biomarker sample testing service that allows researchers to submit samples for quantitative analysis in Searchlight Biomarker arrays. In addition Aushon offers custom microarray printing that it claims offers “unmatched versatility and flexibility”.

This allows Aushon to print virtually any sample on to any substrate, “with unequalled reproducibility, accuracy and rapid turnaround”, according to the company.

 

Aushon also manufactures a range of products for use by researchers. These include chemiluminescent and Infrared Assay Kits and a microarray printer.

 

SUNY-Upstate Breaks Ground on Biotech Center

The State University of New York Upstate Medical University is in the process of building a research center dedicated to biotechnology.

 

The facility is expected to bring research opportunities to Syracuse University and surrounding universities. It could also have an economic trickle-down effect regionally.

 

Biotechnology is genetically engineering organic products for commercial uses. Some of the common biotechnology products include vaccines, pest-resistant crops and new bacterial strains.

 

Construction on the Central New York Biotechnology Research Center began in July. Demolition and clearing efforts are now underway at the site of the former Kennedy Square Apartments. The center is expected to be completed in late 2009 or January 2010.

 

The facility is designed to accommodate different biotechnology companies in separate offices.

 

The center is expected to cost $80 million and will be owned by SUNY Upstate Medical University. Funding has come from state government sources and groups like the state Senate's Gen*NY*sis biotechnology economic development program. The program has donated $5 million toward the research center, according to a news release.

 

As the field of biotechnology grows, influx from partnering companies is expected to bring both jobs and renewed profit to Central New York, said John Fieschko, the center's executive director.

 

Additionally, the State University of New York College of Environmental Science and Forestry is expected to work with the center as a research affiliate.

 

The Metropolitan Development Association of Syracuse and Central New York will work with Upstate Medical University and ESF to establish the center. The MDA is the primary private-sector force behind large projects in the city, according to its Web site.

 

Faculty members from SU and ESF will be able to create start-up companies and potentially employ students part-time for research endeavors related to the biotechnology field, said Steven Goodman, Upstate Medical University's vice president of research and the center's co-chair of the board.

 

The companies may be related to the commercialization of biotechnology, bioenergy, biodevices, stem-cell technologies and molecule therapeutics.

 

With possible occupants of the center coming from within the university, the center should strengthen SU's urban relationship. The connection should bring "the university area to the city of Syracuse," Fieschko said.

 

Ampac Bulks up API Capacity with 3 LLC Units

Ampac Fine Chemicals (AFC) has added three new commercial-scale Hastelloy liquid-liquid centrifuges to its API making business in a move that, it says, will increase batch size and lower manufacturing costs.

 

The firm, a subsidiary of the American Pacific Corporation, installed the new units in series at its active pharmaceutical ingredient (API) production facility in Rancho Cordova, California after trialing the technology in 2008.

 

Richard Beatty, VP of product management, explained that: "The LLC process improvement was demonstrated last year at bench scale by the R&D group and was transferred to commercial scale this summer."

 

"This change in the process is a major milestone in achieving an increased throughput by removing a volumetric pinch point in the overall process. As a result we could increase the batch size significantly and thus reduce costs."

 

AFC president Aslam Malik agreed, adding that: “We expect to see more [demand for] commercial scale continuous processes in the next few years."

 

“We have been doing continuous chromatography at commercial scale for 10 years and earlier this year we opened a kilo facility dedicated to continuous processes. The implementation of these technologies for the manufacturing of APIs is the result of AFC's commitment to continuous processing.”

 

Industrial-scale liquid-liquid centrifuges, as the name suggests, are used to separate one liquid from another. They offer several advantages over traditional extraction methods with the most important being the ability to conduct continuous extraction.

 

This approach has obvious benefits for API makers like Ampac, ranging from shorter production timelines to the need for reduced maintenance.

 

At a time when pharmaceutical firms are increasingly reliant on outsourced production capacity, any contract manufacturing organization (CMO) that is capable of producing more of an API, faster and at lower cost is likely to attract business.

 

Medplast Upgrades Arizona Facility

Medplast has completed an expansion of its 50,000-sq-ft facility in Tempe, AZ. The site includes two Class 100,000 (ISO Class 8) cleanrooms that house injection molding and automated assembly operations. The former general molding and tool maintenance areas have been transformed into white room manufacturing. The Tempe site is a medium- to high-volume medical manufacturing facility. Its primary products include injection molded products, including disposables. As a result of the stringent manufacturing requirements of customers, the entire facility has been upgraded, including the tool room where mold maintenance can be conducted in a clean environment that is separate from design and construction. The renovation of the site gives Medplast greater capacity for cleanroom molding and enables the company to more effectively serve its customers in the Western United States and Mexico. The company also announced upgrades to its facilities in Pennsylvania and New Jersey. Medplast also has facilities in Iowa and Wisconsin. Its five locations house more than 375,000 sq. ft. of manufacturing space.

 

Bayer Sets $100M Retooling of Berkeley, CA, Manufacturing Site

After hinting it may move out of Berkeley, Calif., Bayer HealthCare announced  it will stay in the California city and spend more than $100 million to retool its manufacturing facility there to allow for producing future versions of its hemophilia drug Kogenate, in return for the promise of $13.6 million in tax credits over 10 years.

 

The project marks the largest investment ever made by Bayer at the 43-acre Berkeley site, which employs 1,300 people, Joerg Heidrich, head of Bayer HealthCare's product supply biotech organization, told the Contra Costa Times.

 

The plan hinges on an expansion of the lower-tax state Enterprise Zone where the facility is located. The Berkeley City Council and the state of California are expected to approve the expansion of the zone, which straddles Berkeley and Oakland. The city council is due to take up the enterprise zone issue on Sept. 22.

 

Bayer had considered the expansion as one of several options for producing Kogenate; other options included farming out the work to contract manufacturers, which would likely have resulted in Bayer dismantling the Berkeley facility.

 

After Bayer approached Berkeley earlier this year to inform the city it was considering a move, Berkeley responded by accelerating efforts to join an enterprise zone originally within Oakland. In less than two weeks, Oakland drafted a resolution to add Berkeley and nearby Emeryville, Calif., to its enterprise zone, urging the Oakland City Council to approve the extension at its July 28 meeting — which the council did, unanimously.

 

Genzyme Plans $68M Renovation for Northborough, MA, Set to Consolidate Framingham, Allston Operations

Genzyme plans to spend about $68 million to renovate an existing 210,000-square-foot facility in Northborough, Mass., which the biotech giant will turn into a center for its warehouse and distribution operations, quality control group, finished goods, labeling and packaging group, and its clinical pharmacy research group. Those operations are all being consolidated at Northborough from cramped facilities in nearby Framingham, Mass., and Allston, Mass.

 

About 165 of Genzyme's current employees will work in the Northborough complex, at 11 Forbes Road, upon completion next year, with the company also planning to hire another 30 to 50 new employees. Between 150 and 200 construction workers will be needed for the renovation.

 

A significant part of the money being spent on the site will be used to install heating and air conditioning systems intended to help the new facility earn the second-highest or "gold" rating under the US Green Building Council's Leadership in Energy and Environmental Design certification program, the Metro West Daily News reported.

 

Inside the building, workers have already stripped floors down to concrete and ripped out walls, exposing pillars, wires and beams. Ceilings in the warehouse are 34 feet tall, enough for Genzyme to install stacks of pallets and refrigeration units. Loading docks line two sides of the warehouse.

 

Maryland Biotechnology Center Opens Two Offices

Maryland officials and biotechnology leaders celebrated the opening of two offices for the Maryland Biotechnology Center, a state agency launched earlier this year as a "one-stop stop" for life-sci employers seeking to relocate to Maryland or expand there.

 

The center's eight staffers work from central offices at the World Trade Center building at 401 East Pratt St. in Baltimore, and an office at 9700 Great Seneca Highway in the Shady Grove life-sci campus in Rockville, Md., within biotech-rich, suburban Montgomery County.

 

Lawrence Mahan, the center’s executive director, said that the center was launched with $5.5 million in state funds — $1.2 million from the fiscal year 2009 budget, $4.3 million from the budget of the current fiscal year, which began July 1.

 

He said getting entrepreneurs started will be among the goals of the new office, as will giving them access to information about Maryland’s grant-funding programs, opportunities to collaborate with scientists at local universities and help with developing their businesses, the newspaper reported.

 

The biotech center was the first recommendation of BioMaryland 2020: A Strategic Plan for the Life Sciences in Maryland, a 17-point program to boost the state's life-sci industry hammered out by the Maryland Life Science Advisory Board, a 15-member panel created by Gov. Martin O'Malley. The biotech center was also included in O'Malley's BioMaryland 2020 initiative, a $1.3 billion package of programs intended to catapult the state to the top strata of life-sci leadership.

 

Karen Olson, a member of the state’s Life Sciences Advisory Board and CEO of Baltimore-based BioMarker Strategies, told the Daily Record the board was able to push for a biotechnology center after O’Malley visited a similar center in North Carolina, one of the state’s biggest competitors in the field: “We entrepreneurs were calling for it and then he was able to see how effective that was in North Carolina."

 

Regeneron Pharmaceuticals Expanding in New York

Regeneron Pharmaceuticals in Tarrytown, NY, has hired its 1,000th employee, and plans to hire another 50 staffers by year's end after increasing staff by 35 percent in 2008, the Westchester County Business Journal of White Plains, NY, reported.

 

News of the hiring comes as Regeneron moves into two new three-story buildings totaling 229,000 square feet bamboo-floored, naturally lighted space within the Landmark at Eastview, the life-sci campus owned by BioMed Realty Trust of San Diego. A third building was also constructed, but remains available for lease.  With the expansion, Regeneron now occupies 390,000 square feet of lab and office space at Landmark at Eastview.

 

The company's workforce includes about 300 workers at its manufacturing facility in upstate Rensselaer, NY, a former drug company plant acquired in 1993, as well as staffers at a satellite office for clinical development in Bridgewater, NJ, opened last year in order to attract experienced employees from the Garden State's downsizing pharmaceutical companies, according to the Business Journal.

 

Gerresheimer Invests in Plastics with Two New Plants

Gerresheimer is increasing its presence in the pharmaceutical plastics business, which it believes is increasingly important, by opening an R&D centre in the US and a production facility in Spain.

 

The pharmaceutical plastics sector has become Gerresheimer’s fastest growing business sector and the company has made strategic investments to ensure it has the capacity to meet rising demand.

 

Gerresheimer has achieved this by opening a production facility in Masalaves, Spain that it believes is the largest of its kind in Southern Europe. The plant will serve the Southern and Central European markets and is regarded by Gerresheimer as “a significant strategic base”.

 

From the facility Gerresheimer will produce pharmaceutical bottles and multifunctional dosage and closure systems, for delivery forms such as eye drops, nose sprays and tablets.

 

Gerresheimer has also invested to bolster its R&D capabilities, opening a technological centre in Peachtree City, Georgia, US. The site previously only housed a manufacturing facility but has now been upgraded with the addition of R&D capabilities.

 

Prior to the expansion Gerresheimer lacked a US site that could handle customized serial production of entire product and process development, with only its European sites having this capability.

 

Following the expansion the US site will work on highly developed inhalation systems for respiratory diseases, as well as insulin pens, skin-prick aids and lancets for the diabetes sector.

Gerresheimer has experienced steady growth in these sectors and the expansion gives it the capacity to continue strengthening its market position. Following completion of the recent expansions Gerresheimer has 15 sites operating in the plastics sector.

 

This capacity has been created through acquisitions and targeting investments, which, coupled to organic growth, have helped accelerate the division’s growth over the past five years. The division now accounts for a third of group sales.

 

MA Life Sciences Approves $90M for Center at Worcester's UMass Medical School

The board of the Massachusetts Life Science Center, the quasi-public state agency charged with overseeing Massachusetts' $1 billion, 10-year Life Sciences Act, approved its largest expense to date — $90 million in capital funds toward construction of the $405 million Albert Sherman Center research facility at the University of Massachusetts Medical School in Worcester, Mass.

Slated for completion in 2012, the 500,000-square-foot Sherman Center will be home to the Advanced Therapeutics Cluster, comprising the RNA Therapeutics Institute, the Center for Stem Cell Biology and Regenerative Medicine, and the Gene Therapy Center, and contain wet research space for more than 100 investigators. The Sherman Center will also integrate quantitative “dry lab” methods such as bioinformatics, biostatistics, interactive health outcome assessments and electronic health care data systems with the work of biologists and chemists in the wet labs.

According to an economic impact analysis of the Sherman Center by the UMass Donahue Institute, the construction and operation of the Albert Sherman Center will generate $1 billion of statewide economic impact. That includes more than $400 million in direct construction spending expected to support approximately 6,000 jobs and generate over $760 million in total statewide economic activity during construction, followed by 1,600 jobs and $264 million in annual economic activity throughout the state once operational.

 

Ground for the Sherman Center was broken on Sept. 17.

 

Marine Biological Laboratory Breaks Ground on $25M Renovation of Loeb Laboratory

The Marine Biological Laboratory in Woods Hole, Mass., broke ground on a $25 million renovation of the MBL’s central research training facility, the Loeb Laboratory. The renovation, set to be completed in spring 2010, is a key step toward establishing a Center for Regenerative Biology and Medicine at MBL.

 

MBL said the renovation will create 250 regional construction jobs over the next 15 months, as well as enhance its ability to attract and retain top scientists.

 

Loeb Laboratory has been the cornerstone of MBL’s life sciences training programs since 1970. The renovation is being funded with a $15 million donation from the Howard Hughes Medical Institute, and $10 million from the Massachusetts Life Sciences Center, the quasi-public state agency charged with overseeing Massachusetts' $1 billion, 10-year Life Sciences Act.

 

The combined $25 million will not be enough to build the project because construction bids came in at closer to $28 million; MBL hopes it can cover the difference through funds from the American Recovery and Reinvestment Act, the $787 billion economic stimulus measure enacted in February by President Obama.

 

“The MBL trains over 450 scientists each year in Loeb and this renovation is critical to maintaining our position as a leader in scientific research and education," MBL Director and CEO Gary Borisy said in a statement.

 

The renovation was designed by Tsoi/Kobus & Associates. Shawmut Design and Construction is overseeing the project and will gut the building’s internal infrastructure to create a more modern facility that will bring all of MBL’s research-training programs into the building, and create spaces designed for each discipline.

 

Michigan Life Science and Innovation Center Opens in Plymouth, MI, Ex-Pfizer Facility

Partners in the creation of the Michigan Life Science and Innovation Center celebrated the facility's opening in a former Pfizer facility in Plymouth, Mich.

 

The partners — Michigan Economic Development Corp., nonprofit regional economic development group Ann Arbor SPARK, the Greater Wayne Economic Development Corp., and an undisclosed private foundation — spent $4.5 million to acquire the 57,518-square-foot facility from Pfizer, then renovate it into a site designed to connect entrepreneurs with business accelerator organizations and start-up life science companies.

 

"By offering state-of-the-art labs and start-up support in one location, MLSIC will be a catalyst for the growth of biotech and life sciences companies in southeast Michigan," Michael Finney, president of Ann Arbor SPARK, said in a statement.

 

The center said it will offer business acceleration services that include peer-to-peer mentoring designed to connect experienced entrepreneurs with start-up ventures, as well as access to wet lab and research space, and funding support.

 

Life sciences and related tenant companies at the new center include:

 

         Algal Scientific Corp., a biotech company working to develop a system to convert proprietary algal strain into fuel.

 

         Distributed Compliance Solutions, a compliance solutions hosting firm for small- to medium- sized life-sci companies and government agencies.

 

         Esperion Therapeutics, a developer of therapies intended to prevent, treat, and reverse cardiovascular and metabolic diseases.

 

         Lycera, a developer of small molecule drugs for the treatment of psoriasis, rheumatoid arthritis, lupus and cancer.

 

         Milad Pharmaceuticals Consulting, which assists clients in pharmaceutical kinetics and pharmaceutical development.

 

         Next Generation Therapeutics, a biotechnology company that focuses on novel nano- and microplatforms for drug delivery and imaging of cancer and in-licensing promising pharmaceutical and medical device technologies.

 

         Velesco Pharmaceutical Services, a contract research organization that provides laboratory services and clinical supplies to smaller pharmaceutical companies.

 

MLSIC said in the statement its ongoing operational costs will be funded through a combination of public, private and foundation support.

 

Massachusetts College of Pharmacy and Health Sciences Opens New $10M Academic Center in Worcester

Massachusetts College of Pharmacy and Health Sciences officially opened a new $10 million, 30,000-square-foot academic center in downtown Worcester, Mass. The new center occupies the former Protocol Building property, at 40 Foster St., which the college purchased in August 2008.

 

The new center is named for alumnus Ahmad Alhaddad, a Class of 1986 graduate who has pledged $1.2 million for the project. The Alhaddad Building contains academic space, including a multi-purpose pharmacy laboratory with 64 stations; two 250-seat distance education auditoriums; three 50-seat “smart" classrooms; 20 faculty offices, and a glass-enclosed, street-level student lounge.

 

The new facility would nearly double the amount of space at the School of Pharmacy Worcester/Manchester, which last year received 3,000 applications for 150 slots. The college expects the new space to help it dramatically increase the number of pharmacy students it can enroll over the next three years, to 750 Doctor of Pharmacy students (1,000 students total across all programs) at MCPHS-Worcester.

 

Francis Harvey & Sons of Worcester oversaw construction of the facility, while Janet Stegman and Alan Westman of Stegman and Associates Architects served as project architects, and Kristine Stoller of Kristine Stoller Interior Design served as project interior designer.

 

With campuses in Boston, Worcester, and Manchester, New Hampshire, the college enrolls about 4,000 students from 35 states and 34 foreign countries, and employs more than 400 faculty and staff.

 

Buck Institute Working on Two Plans to Finance $41 Million Novato Campus

The Buck Institute for Age Research said it is working on a pair of plans to secure financing for the $41.4 million laboratory and support building planned for its Novato, Calif., campus — a project to be partially publicly funded through California's stem cell agency — following a year of delays wrought by the economic downturn.

 

Buck is awaiting word from Washington on its application for a $15 million facilities grant through the American Recovery and Reinvestment Act, the $787 billion economic stimulus measure enacted in February by President Obama. The institute expects to receive an initial score in October, and a final disposition by December on its application for grant funds to build the 65,708-square-foot second research building.

 

Kovach said Buck recently issued a formal request for proposals from prospective lenders interested in underwriting the second research building. Buck, a private research institution focused solely on aging and age-related disease, would use part of the proceeds to retire an existing $55.6 million bond with a variable interest rate set week-to-week based on the financial market, and use the remainder for construction and equipment costs for the project.

 

The institute expects to select one or two lenders for the new financing.

 

Whether through ARRA or a new bond, the financing would help pay for a facility designed to house up to 25 faculty members, including 12 new principal investigators, along with a cell banking facility, a cafeteria, and fitness center.

 

The cell banking facility would take up "6,000 to 7,000 square feet. Minus 80 freezers, you could store thousands of cell lines in that," Kovach said. "The need is out there because there is no public biorepository on the West Coast that is as high in quality as the Coriell Institute" for Medical Research in Camden, NJ.

 

He said Buck's planned biorepository will also have the advantages of its location, on a granite mountain that meets earthquake-resistant building codes, and within a 30-minute drive from two airports, making it convenient for researchers.

 

The institute originally envisioned breaking ground in September 2008 for the lab/support building, designed as an addition to Buck’s existing 185,000-square-foot research facility.  But as the financial markets soured last fall, Buck, as with many institutions planning facility projects, found it harder to raise the funds it needed for a groundbreaking, resulting in the institute delaying its construction and talking with prospective partners about financing alternatives.

 

Advanced Electron Beams (AEB) Expands Aseptic Packing

A U.S. company that uses electron beams to sterilize aseptic packaging plans to use a $14m-cash-injection to develop new technology, increase sales and boost its finances.

 

Massachusetts-based Advanced Electron Beams (AEB) said the latest funding brings the total raised by the company to more than $50m. The company said it hoped to use the funding to develop its air pollution control space technology, where companies could use e-beams instead of burning pollutants.

Josh Epstein, director of marketing, said the company is also developing a new, smaller emitter, with a narrower nozzle that will fit inside beverage containers. The product is expected to be introduced in September.

 

CEO Mitch Tyson added: “No one has been able to do that up until this point.”

 

He said he hoped the cash infusion would get the cash-flow negative company to break even.

 

AEB also announced it is expecting to receive two letters of non-objection from the Food and Drug Administration for new technology in the near future.

 

Poised for growth

E-beams have been used for decades in the food and beverage sectors. They work by directing a shower of accelerated electrons through a high-voltage emitter towards a target. However, a number of developments in recent years suggest the technology is poised for substantial growth, said Epstein.

 

One advancement is the miniaturization of the technology. Where units often measured 20 feet by10 feet (approx 6m x 3m), they had now shrunk to one hundredth of that size. This means the systems can be integrated into beverage filling equipment, eliminating the need to bring containers to dedicated irradiation centers.

 

Another development is the growth of aseptic packaging, particularly in the beverage industry as demand “moves away from carbonated soft-drinks towards functional beverages, ready-to-drink teas and coffees and dairy-based drinks,” said Epstein.

 

E-beam technology offers a chemical-free alternative to conventional sterilization, as well as delivering reduced energy costs, a smaller processing footprint and a cut in water consumption as it eliminates the need for rinse water, he added. The process also results in lightweighting of packing design because no heating is involved in the sterilization procedure. The company said its technology help traditional aseptic manufacturers become more sustainable.

Epstein said that while capital costs for e-beam technology were “slightly higher” than conventional sterilization systems, payback could be achieved within 12-18 months on energy savings alone.

 

AEB is working with 12 original equipment manufacturers at various design stages, as well as 50 customers - 19 of which are Fortune 1,000 companies, said the marketing director. Around 75 per cent of its clients are in the food and beverage industries, with the rest from the pharmaceutical sector. The company has shipped 200 of its e-beams worldwide, mainly in the United States, Europe and Japan.

 

 

REST OF WORLD

 

Siro Clinpharma Ramped Up Clinical Trial Manufacturing in Mumbai

Indian CRO Siro Clinpharma has ramped up clinical trial manufacturing capacity at its facility in Mumbai in response to growing demand from pharma and biotech firms.

 

The expansion, financial details of which have not been released, covers both manufacturing capacity and inventory management infrastructure according to company VP Jayanti Vaidyanath.

 

Vaidyanath explained that the firm started offering trial supply services in 2003, beginning with a modest 18,000 sq. ft. of manufacturing and warehouse space at its Mumbai facility.

 

She added that: “Now, with the expanded facility, we have a bigger area of 6200 square feet,” adding it includes two walk-in cold rooms at 2-8 degree storage, ambient storage at 15-25 degrees and storages for temperature ranges between -20 and -70 degrees."

 

Vaidyanath went on to say that Siro has also invested in its inventory management process, selecting Oracle Siebel’s CTMS tool to run stock control and distribution operations.

 

Ajit Nair, who head up Siro’s Indian operations, stressed the customer service benefits of the additional capacity, explaining that: “The facility expansion will enable us to handle many more orders thus increasing our ability to serve a wider client base.”  Dr Nair went on to say that Siro’s recent partnership with New Jersey based pharma services firm Advanced Clinical Trial Solutions (ACT), signed in April, will also benefit from the facility expansion.

 

Glaxo to Create UK Science Park

GlaxoSmithKline has entered into a partnership with the UK Government, the Wellcome Trust and the East of England Development Agency, to develop an innovative new biotechnology science park located at Glaxo's site at Stevenage.

 

The project aims to create a world-leading hub for early-stage biotechnology companies. The campus will pioneer a new operating model of open-innovation that should strengthen and grow the UK bioscience sector.

It's hoped that this campus, supported by government, business and academia, will compete with those in Boston, California and North Carolina in the U.S. The UK is second only to the U.S. for basic bioscience research and is supported by leading universities, pharmaceutical companies and research institutes located mostly in southeast England.

 

Companies locating in the park will have shared access to specialist skills, equipment and expertise to stimulate new innovation in drug development. Through knowledge-sharing and collaboration, each company will also significantly increase its chance of success. It's anticipated that when complete, the new center will be the base for approximately 1,500 scientists.

 

Business Secretary Lord Mandelson says, "Innovation drives commercial invention; it pushes up productivity; it is at the heart of growth. And this joint investment by the public, private and charitable sectors recognizes that innovation will be decisive in Britain's recovery.

 

"The Stevenage Campus represents a huge investment in the future of Britain's bioscience industry and is a strong new platform for the work of our Office for Life Sciences. It will leverage our existing strengths as a world leader in the sector, helping it to grow and reinforcing our international competitiveness. And ultimately it will help us build towards a stronger UK economy coming out of the global downturn."

 

Initial funding of almost $60 million for the science park will be provided by a range of stakeholders led by EEDA. The Department for Business, Innovation and Skills (BIS) has agreed to provide $18.6 million through a strategic fund and an additional $8 million from the Technology Strategy Board. GSK will provide land, facilities and investment totaling almost $17.5 million. The Wellcome Trust will provide $9.5 million and the EEDA will provide $6.4 million.

 

Richard Ellis, Chairman of EEDA, says, "The announcement strengthens the UK as a world leader in life sciences. It will create new jobs and will enable us to compete on a global stage."

 

GSK is the largest private sector funder of R&D in the UK, investing about $2.1 billion in the R&D of new and innovative medicines in the UK in 2008.

 

Merial Animal Health Invests $70 Million in Nanchang, China

Merial, the Animal Health division of the sanofi-aventis Group, has announced that Merial Animal Health Co. (China) held a ground-breaking ceremony for an expansion project at its plant located in the Nanchang Hi-tech Development Zone, China. Merial Animal Health Co. (China), a venture of Merial Limited and the Group's first production facility in China has been in operation for almost 20 years.

 

The facility in Nanchang produces poultry vaccines for the domestic Chinese market. Upon completion of the expansion project, which earmarks an estimated total investment of over 70 million US dollars, the production capacity of the Nanchang plant will double. The new facility covers a land of 50,000 square meters, with a phase I floor area of nearly 30,000 square meters

(322,800 sq. ft.).

 

"Merial has been operating with our partners in China for nearly 20 years," declared Jose Barella, Executive Chairman of Merial. "During that time, we have been proud to have joined our Chinese partner organizations in enhancing the quantity and quality of poultry protein to meet the ever-increasing demand by consumers here. Now, with the establishment of this new state-of-the-art facility, we have the ability to further apply the latest in modern avian vaccine technology and further contribute to the country's production of poultry protein, and help feed a vibrant and modern China. We hope that this milestone in our growing relationship with China is a symbol of our commitment to this market, and an indication of our desire to further expand our operations in the future."

 

The expansion project is expected to extend Merial's leadership in China in terms of high-quality vaccine offerings as well as sales, technical support and logistics, and positions Merial as a truly trusted partner for Chinese customers and veterinary professionals for business excellence.

 

Catalent Pharma Solutions German Facility Successfully Completes FDA Audit

Catalent Pharma Solutions announces that its integrated dose form development, manufacturing and packaging facility in Schorndorf, Germany, has successfully completed an FDA inspection. This inspection, triggered by pre-approval inspection requirements for two separate products, resulted in three minor observations on FDA Form 483. The Schorndorf facility currently produces products approved by other regulators including those in Germany, Brazil and Taiwan.

 

Catalent's Schorndorf business, originally founded in 1973, provides formulation and development services, clinical and commercial manufacturing for oral tablet and capsules, powders and other dose forms. The business also provides clinical and commercial packaging, clinical supply chain management services, and integrated product development and commercial supply chain solutions for products in these dosage forms.

 

Sharon Johnson, Catalent's Executive Vice President of Quality, said, "The success of this inspection again demonstrates Catalent's operational performance, depth of regulatory expertise, track record of quality and commitment to excellence. We are pleased to offer our customers added flexibility in their supply chain options for products coming to the United States."

 

US CRO Charles River Laboratories (CRL) Cuts Staff at Facility in Montreal, Canada

US CRO Charles River Laboratories (CRL) has laid off staff at its facility in Montreal, Canada in response to customer postponement of research plans.

 

The cuts affected 115 employees at CRL wholly-owned ClinTrials BioResearch subsidiary in Senneville in the west of the city.

 

Company spokesperson Amy Cianciaruso told the Montreal Gazette that the move is “something we have previously discussed and while we had expected that these companies would have fully resumed most of their R&D projects, it is clear that is not yet the case.”

 

Cianciaruso added that: “Like others in our industry, Charles River has been affected by this slowdown and we are taking the difficult but necessary steps to align our workforce with the current demand.”

 

The reduction leaves the Massachusetts, US-headquartered contract research organization (CRO) with a workforce of around 1,480 employees in Montreal.

 

Charles River Shanghai Facility Gains Accreditations

Charles River Laboratories’ new Shanghai facility received accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), the Canadian Council on Animal Care (CCAC) and the Shanghai Laboratory Animal Commission (SLAC). The AAALAC recognizes humane care of research models, CCAC acknowledges veterinary services, and SLAC acknowledges animal welfare policies.

 

The 60,000 sq ft facility, which was opened in 2008, is intended to help CRL capture a share of the country’s expanding preclinical drug testing market.

 

“These three accreditations are a milestone in Charles River’s strategy to create a Center of Excellence in China,” said James C. Foster, president, chairman and chief executive officer of Charles River. “As the leading international CRO with GLP capabilities in China, we are replicating the Company’s high standards of research, safety, humane care and laboratory best practices that globally distinguish Charles River.”

 

GlaxoSmithKline Forms Joint Venture with Jiangsu

Drugs maker GlaxoSmithKline Plc and Jiangsu Walvax Biotech Company said they are forming a joint venture to develop and produce pediatric vaccines for measles, mumps and rubella (MMR) in China.

 

GSK said it would transfer technology for other vaccines to be produced by the joint venture, in which it would hold a 65 percent interest and would initially invest 20.1 million pounds ($30 million). It would invest a further 7.3 million pounds in 2015.

 

Walvax will invest a total of 13.8 million pounds, the announcement said.

 

Jiangsu Walvax is an affiliate of Yunnan Walvax Biotech Co., Ltd., China's second-largest manufacturer of Haemophilus influenza type b (Hib) conjugate vaccine.

 

"This collaboration will allow Walvax and GSK to produce lifesaving vaccines to help meet China's need for MMR vaccines," said Liu Hong-Yan, Chairman of Walvax. "The JV will strengthen our vaccine R&D efforts and build our capacity to increase children's access to vaccines, one of the most cost-effective health interventions available."

 

In June, GlaxoSmithKline also signed an agreement with Chinese biotech company Shenzhen Neptunus Interlong Bio-Technique Co., Ltd. to develop and manufacture flu vaccines.

 

GSK shares were up 0.9 percent at 1,230 pence on the London Stock Exchange.

 

Ireland’s Almac Gets OK to Build on 5.4-Acre Parcel Near HQ

Northern Ireland drug maker Almac has secured permission for an expansion plan that could see the company create more than 500 jobs during the next five years.

 

The company, which provides integrated research, development, and manufacturing services to pharmaceutical and biotech companies has acquired a 5.4 acre site adjacent to its Craigavon headquarters, and will “shortly embark on the first phase of development” there, the firm said in a statement.

 

In 2008 UK-based staff rose 15 percent to 1,426 while those based in the US rose 10 percent to 762, Almac said. The company also announced the creation of 128 new graduate and research positions in the first two months of 2009.

 

The initial phase of the planned development will see Almac construct a three-story office unit to accommodate over 220 existing staff and expected recruits. To accommodate the second phase, the company obtained permission from the city to build a new research facility and a new distribution unit to expand existing capacity.

 

€14.8 Million Approved for New Systems Biology Ireland Research Center

Ireland's government has agreed to spend €14.8 million ($21.8 million) over the next five years to establish the Science Foundation Ireland Centre for Science, Engineering & Technology in Systems Biology, a new research center to be led by University College Dublin and its Conway Institute.

The center will employ 69 people and focus on systems biology, the mapping of interactions between the elements of a biological system and the building of models intended to accurately reproduce that system’s behavior. The new research center is also being supported through industry partners that include Ark Therapeutics, Hewlett Packard, Servier, Agilent Technologies, Siemens Ireland, and Protagen.

 

The new center, also called Systems Biology Ireland, "should greatly assist the [Industrial Development Agency] to attract further high-end foreign direct investment, and also allow Irish SMEs to grow," Ireland's minister for science, technology and innovation, Conor Lenihan, said in a statement.

 

Systems Biology Ireland "is working with a range of industry partners to develop new technologies for biomedical research," the statement also said.

 

Vetter Inaugurates its Ravensburg, Germany Site for Pharmaceutical Production

Vetter recently inaugurated its Ravensburg South site with a new 862,000 sq.-ft. area that now includes facilities for the aseptic filling and packaging of injectable drugs. The location features three buildings: a production facility, a final assembly and packaging plant, and a lab for ongoing production-related analyses. The company has invested approximately $220 million in the site and is investing another $73 million to expand pharmaceutical production.

 

The new location features maximum production automation, the use of RABS (Restricted Access Barrier Systems), central material supply with optimized material flows, and two independent filling lines. The two filling lines were the first segments of the expanded production site to begin operating in early 2007. Currently, final preparations are being made for a third production line, which is scheduled for completion by mid 2011.

 

The new Vetter Secondary Packaging (VSP) facility, in which the final assembly and packaging of the pre-filled injection systems is handled, is the last step of the company’s complete service offering. The entire VPS process, from hand-packaging and assembly of pens, auto-injectors and safety devices to the fully automated final packaging, takes place in the Ravensburg South plant. It has been operating fully since May 2009.

 

The final component of the Ravensburg Vetter South Laboratory (RVS-Lab) is the new lab, which includes a microbiological lab and chemical analysis area in new, specially designed spaces.

 

Patheon Opens New Pharmaceutical Development Services (PDS) Manufacturing in Italy

Canadian CMO Patheon has opened a new Pharmaceutical Development Services (PDS) manufacturing site for investigational medical products within its existing manufacturing facility in Ferentino, Italy.

 

The new facility, due to open in November,  will manufacture sterile products including aseptically filled, terminally sterilized liquids and lyophilization. It also includes development and quality control labs. Three lyophilization units will be available, with two dedicated to development activities for non-human use and one dedicated to the manufacture of clinical trial materials.

 

The area is designed to accommodate future expansion and is set up specifically for the scale-up of products for clinical use following the completion of development activities on site, and will support mechanisms for the manufacture of biopharmaceutical products. Capabilities will include the manufacture of highly potent drugs, poorly soluble, oxygen and light sensitive compounds, and highly hygroscopic lyo-products. The space is also equipped with a dedicated water and HVAC system.

 

The expansion doubles PDS manufacturing capabilities for clinical batches and analytical lab capabilities. The new area will be completed for use in November 2009 and will employ an additional 10 process specialists and development scientists.

 

Patheon’s chief executive officer, Wes Wheeler, stated, "Our new PDS facility will be of strategic importance in order to feed the pipeline of Patheon's two commercial sites located in Italy, offering clients a one-stop shop, from early development all the way through to commercial manufacturing."

 

The Canadian contract manufacturing organization (CMO) stressed that the development new unit can produce a wide range of drugs, including highly potent compounds, those that are poorly soluble, those that are sensitive to oxygen or light, as well as those that are highly moisture absorbing, or hygroscopic.

 

Quintiles Doubles Central Lab Capacity in Expanded Site near Edinburgh

Quintiles has opened an expanded facility near Edinburgh, Scotland, doubling its central lab capacity with the intent of improving its service in Europe. The new 115,000-square-foot facility employs more than 500 people who provide lab services that include chemistry, hematology, biomarkers and coagulation.

 

The facility's new 80,000-square-foot central laboratory more than doubles the company's previous capacity, and increases throughput of clinical trial materials by processing up to three times more kits per day. The site also houses one of Quintiles’ three assay development laboratories, each specializing in the technical transfer of methods and assays, as well as in validating commercial instruments and assays for research.

 

The new facility is certified for sustainable design and low environmental impact under the Building Research Establishment Environmental Assessment Method, or BREEAM.

 

The expansion is part of a company strategy of locating its central laboratories across five continents, which the company believes will allow it to cut transportation costs, reduce concerns about import and export permits, provide better support to local investigators, and enhance the stability of its samples.

 

Vancouver, BC, Biotech Firm Radient Consolidating Operations in Edmonton, Alb.

Radient Technologies will consolidate in Edmonton, Alberta, all of its operations, now scattered between its headquarters in Vancouver, BC, plus operations in the Ontario communities of Burlington and Whitby, said the company's new CEO David Cox.

 

Radient is moving into a 14,000-square-foot facility on Roper Road in South Edmonton to house its headquarters and research and development, and is looking for another building for its manufacturing process. Radient's new headquarters used to house Edmonton's ViRexx Medical, which laid off all staff last year following the failure of its lead cancer drug in clinical trials.

 

Radient uses patented microwave energy technology developed by Environment Canada to extract valuable compounds from plants used in the manufacture of pharmaceuticals and cosmetics.

 

The 22-employee company expects to hire another 30 to 40 new workers in Edmonton over the next 18 months. It is not known yet how many employees from British Columbia and Ontario will move with the company to Edmonton.

 

The relocation is a blow for Vancouver's biotech sector, a newspaper noted, citing Eli Lilly's decision earlier this month to sever ties to a local firm, BioMS, following the failure of its potential treatment for secondary progressive multiple sclerosis in advanced trials.

 

Cox left his previous position as CEO of business incubator TEC Edmonton two weeks ago to head Radient, after a recruiter for the company approached him.

 

Sirona Biochem Stepping Up Drug Development after French Partner Opens State-of-the-Art Lab

Sirona Biochem, an emerging Vancouver, BC, biotech company focused on diabetes and obesity, said it is accelerating its drug development program following a visit to the new, French government-funded 5,400-square-foot laboratory of its French partner, TFChem SARL, in Val de Reuil, France, near its headquarters in Rouen, France.

 

Sirona has entered into an agreement with TFChem, which licenses to the Canadian company its technology of fluorinated carbohydrate mimics, as well as products in development to biotech companies. The agreement provides for research and development of new compounds known as SGLT inhibitors, which the companies view as having the potential to treat both diabetes and obesity.

 

"The additional researchers and equipment will allow us and our partner TFChem to make even greater strides, accelerating research into our unique family of molecules for obesity and diabetes drug development. Inevitably, we believe Sirona Biochem will benefit significantly," Mark Senner, Sirona's president, said in a statement soon after his return from a ceremony making the opening of TFChem's plant in Val de Reuil, France.

 

GE Healthcare Invests $1 Billion for Lab in India

GE Healthcare has invested $1 billion to set up an advanced research lab in Bangalore, India. The lab will be established at the John Welch Technology Centre in Whitefield, which covers an area of 50,000 ft2 to develop global products.

 

With this funding, the total investment in India by GE Healthcare for this fiscal has reached $3 billion. These investments are meant for the company's new business model “Healthymagination.” This model focuses on low-cost and high-quality products which can be affordable for patients in the emerging markets.

 

The lab will focus on designing products that are developed in India for the global markets. The company has set a target of over 100 products in the medical devices and life sciences space including AKTA chromatography instruments, as some of these medical products have already hit the Indian market. Instruments include MAC 400, Lullaby Baby Warmers and the Tejas XR 6000 X-ray system.

"Globally, the effort has been to drive the healthcare business in the markets of India and China. The company has invested substantially even during tough times in both technology and human resources. We are working on various technologies in India covering ultrasound, X-rays, Computerized Axial Tomography (CAT) Scan, Magnetic Resonance Imaging (MRI) besides life sciences and surgical sciences," says Ashish Shah, General Manager of Healthcare Technologies for GE.

 

GE Healthcare has workforce strength of 1,200 and is planning to add another 70 from areas of mechanical, electronics and software background.

 

French BioMerieux Opening a New Facility at its Crapone, France Site

French company BioMerieux has boosted the capacity of its customized manufacturing of culture media, used in microbiological control, with the opening of a new facility at its Crapone plant.

 

A company spokesman said, “Customized manufacturing applies to a wide range of culture media formulation such as LX broth used for selective enrichment of Listeria before detection, Hektoen agar used for the selective growth and isolation of Salmonella and Shigella or ChromID 0157:H7 for selective growth and isolation of E.coli O157:H7.”

 

The culture media are used in the food and beverage sectors to detect pathogenic micro organisms that could compromise food safety or quality.

 

Alexandre Merieux, corporate vice president said: “This newly created facility enables us to satisfy our customers’ increasing needs for flexibility and special batch sizes to complement our standard product range.”

 

A wide degree of flexibility in packaging, volume and media formulation is necessary to allow agri-food and biopharmaceutical companies to meet their customers’ demands for demanding quality requirements, he added.

The new plant in south-eastern France, where the company’s main culture media production is located, will allow the supply of very specific culture media regardless of the batch size to be produced.

 

“Custom manufacturing is already possible at several BioMerieux sites,” said a company statement. “The creation of this new production unit heralds an important new step in the company’s commitment to improving consumer satisfaction.”

 

The culture media can be supplied in tubes, plates or bottles.

 

The company’s products are validated and produced in compliance with ISO 9001 and Good Manufacturing Practice standards, it said.

 

In addition to advising customers on the most appropriate microbiological solution, the company said it can offer scientific support to facilitate product validation on customers’ own premises.

 

Nycomed Plans €75m Russian Plant; May up €4.5bn Bid for Solvay

Swiss drugmaker Solvay confirmed its plan to invest up to $75m (€51m) to build a new manufacturing plant in Yaroslavl, Russia.

 

Nycomed, which generates 10 per cent of its annual turnover from pharmaceutical sales in Russia, said that the facility will make sterile liquid products and tablets for the country’s drug market, including Cardiomagnyl, Actovegin, Calcium and Warfarin.

 

The plant, first mooted in July, meets with current good manufacturing practice (cGMP) standards and will employ around 150 people when it becomes fully operation in 2014.

 

CEO Hakan Bjorklund said that: “Russia-CIS is an important cornerstone in our growth strategy, and optimally serving this market is vital for Nycomed” and added “the investment underlines our belief in [its] long-term prospects.”

 

Senior VP Jostein Davidsen agreed about the importance of the Russia market to Nycomed, explaining that the firm had look at a number of locations before selecting the site.

 

Davidsen said that: “A key factor in our decision was the long-term availability of a qualified workforce, where the medical academy in Yaroslavl plays an important role,” adding that “we are confident that we made the right choice.”

 

Russia’s Pharmaceutical Market

Nycomed’s contention fits about the strength of the Russian market with the findings of an Espicom report released in June.

 

The analysts revealed that drug sales in Russia generated $11bn (€7.5bn) in 2008 and predicted that the market will expand at a rate of 17 per cent a year, reaching a value of $22bn by 2013.

 

Espicom also said that 74 per cent of all pharmaceutical sold in Russia are imported, which suggests that current manufacturing capacity in the country is not able to keep up with growing demand and further supports Nycomed’s decision to expand.

 

Additionally the new facility, coupled with Nycomed’s existing strength in the Russian market, should serve it well as it competes with firms like Gedeon Richter, Krka and Lek which are all active in the country.

 

In other Nycomed news, reports have emerged that the Swiss firm is considering upping its EUR4bn bid for Solvay’s pharmaceutical unit.

 

The Wall Street Journal said that Solvay’s board will meet to discuss a potential EUR4.5bn offer after Abbott Laboratories and chemicals firm UCB are considering making a rival bid for Solvay’s unit.

 

West Pharmaceutical Services Opens New Injection-Molding Factory in Shanghai China

West Pharmaceutical Services, Inc. has opened its new 129,000-sq.-ft. injection-molding factory in the Shanghai Qingpu Industrial Zone (SQIZ) in China. The company will manufacture TrimTec and InsoCap closures for intravenous solution bottles and will also export the closures to other markets in Asia, Europe and South America. The Qingpu plant currently employs 52 people and is ISO:9001 certified.

 

The company, which is based in Lionville, PA, develops drug-delivery technologies.

 

“West is experiencing an exciting period of growth in the Asia Pacific region and we are proud to open our first manufacturing operation in China,” said Donald E. Morel, Jr., West’s chairman and chief executive officer. “This facility was established in direct response to client demand, and we are committed to supporting the growth of our pharmaceutical customers in China.

 

West broke ground for the plant in January 2008. Following completion of systems validation and testing, full commercial production will begin late in 3Q09.

 

West next plans to build a plant on land adjacent to the new facility that will manufacture vials and prefilled syringes, according to Ron van Dijk, president of West’s Asia Pacific division.

 

Construction of the second facility will add to capacity in Singapore and allow it to meet rising global demand, in particular in China. West’s new facility was built for similar reasons. The site in Germany, which also produces closures, is running out of capacity.

 

The facility in China is currently producing a product for one customer. Once this client conducts an audit and validates the facility it will be fully operational and can begin helping meet the rising global demand for West’s TrimTec and InsoCap closures for intravenous solution bottles.

 

Efforts to improve drug safety standards in China have resulted in rising demand for the closures. This will be met by the new facility which will also manufacture products for regions including India, Vietnam and South America.

 

The facility currently employs 52 people and covers 12,000 sq m (129,120 sq. ft.).

 

China Packaging Firm Reaps Rewards from Food Safety Law

A specialist packaging company in China has said the newly implemented food safety law has boosted business as it announced it had secured a lucrative contract with the leading domestic meat processor.

 

Shiner International said it has signed an agreement to supply coated food safe packaging to the country’s largest meat processor, Shineway Group, in a deal that could be worth more than $7m a year.

 

The packing company said it believes the food safety law that came into operation at the beginning of June this year in China was already helping it recover from the tough business climate triggered by the global economic downturn.

 

Shiner president Qingtao Xing said: “The passage of the new Food Safety Law that went into effect on June has impacted many food processing companies in China, causing them to find suppliers of coated materials with barriers designed to keep bacteria out and freshness in the package. This is a strong ray of light in what has been a difficult past for Shiner, due in large part to the global economic recession.”

 

Jian Fu, Shiner CEO said the company had anticipated growth following the enactment of the food safety legislation overhaul that came in the wake of the melamine-tainted milk scandal in 2008.

 

“With the positive economic indicators in China and implementation of more stringent food safety laws, the Chinese demand for our state-of-the-art food safe packaging films should continuously increase.”

 

Shiner recently announced it was to receive more than $4m in government funding to expand its food safety packaging operations in a bid to meet growing demand for the products and reduce domestic reliance on imports.

 

The company said the cash would be used to expand capacity at its plant in Hainan from its current level of 15,000 t/a to 50,000 t/a by 2013.

 

Shiner is a US corporation that has its primary operations in China. Headquartered in the city of Haikou, its produces coated packaging film, shrink-wrap film, common packaging film, anti-counterfeit laser holographic film and color-printed packaging materials. Around 60 percent of the company’s customer based is located in China.

 

McIlvaine Company,

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