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Indian Association Calls for Biotechnology Fund
July 27th 2006The Associated Chambers of Commerce and Industry of India (Assocham, www.assocham.org) have called for the establishment of a National Biotechnology Development Fund and a National Nanotechnology Development Fund, with outlays of approximately US $1 billion (Rs. 4,800 crore) and US $2 billion (Rs. 9,600 crore) respectively.
Emisphere and Roche To Develop Oral Formulations of Large Molecules
July 27th 2006Emisphere Technologies, Inc. (Tarrytown, NY, www.emisphere.com) has signed a multi-product research agreement with Roche (Basel, Switzerland, www.roche.com) to explore the use of Emisphere's eligen technology in feasibility studies for new oral formulations of Roche molecules.
The Pharmaceutical Institute Launches Online Biopharmaceutical Training Program
July 27th 2006Biotechnology and pharmaceutical companies seeking to train employees, or even to create their own "online university" can now partner with The Pharmaceutical Institute (PI, Raleigh, NC, www.pharmainstitute.com).
Biologics Firm Receives FDA Warning Letter
July 27th 2006Envita Natural Centers of America (Scottsdale, AZ, www.behealthyamerica.com) received a warning letter from the FDA on June 14 that states that the firm's manufacturing process violates the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.
Bayer to Market Biocon's Insulin in China
July 27th 2006Biocon Ltd. (Bangalore, India, www.biocon.com) has signed a licensing agreement with Bayer Healthcare LLC (www.bayerhealth.com), a subsidiary of Bayer AG (Leverkusen, Germany) for exclusive rights for its branded recombinant human insulin, Insugen, in China.
Northfield Labs To Build First Manufacturing Site
June 28th 2006Northfield Laboratories Inc. (Evanston, IL, www.northfieldlabs.com) has agreed to purchase a building it previously leased in Mt. Prospect, IL, to house its first commercial manufacturing facility to produce PolyHeme, Northfield?s human hemoglobin-based oxygen carrier, used to treat urgent, large-volume blood loss in trauma and surgical settings.
GTC Receives Payment Following Opinion on ATryn
June 28th 2006GTC Biotherapeutics Inc. (Framingham, MA, www.gtc-bio.com) has been awarded a $1 million payment from LEO Pharma A/S (Ballerup, Denmark, www.leo-pharma.dk) for receiving a positive opinion on a market authorization application for ATryn, from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA).
Linking Manufacturing Specifications to Clinical Results Often Challenging
June 27th 2006"Clinical data is the gold standard" for setting manufacturing specifications, said Patrick Swann, PhD, acting deputy director of the Division of Monoclonal Antibodies at FDA, at a session on specification setting at the AAPS National Biotechnology Conference that was held June 19-21 in Boston.
Accept No Limits on Mammalian Cell Expression
May 1st 2006Instead of investing in new facilities, the industry should focus on improving manufacturing technology to increase yields, says Timothy Charlebois, PhD, director of cell and molecular sciences for Wyeth (Madison, NJ, www.wyeth.com). Charlebois made these remarks in his introduction to the session, "Frontiers and Economics of Mammalian Cell Expression," at the BIO 2006 convention."I've seen examples where we took a process that produced 3 grams of protein per liter, and were able to optimize it so that it produced 9.6 g/L," he said, adding that future yields are likely to be above 10 g/L.
FDA Announces Smallpox Vaccine Guidance for Blood Industry
January 2nd 20032 JANUARY - FDA has issued guidance for the blood industry regarding procedures for properly qualifying potential blood donors who have recently been inoculated with the smallpox vaccine (vaccinia virus) or those who may have had other direct exposure to smallpox vaccines.