Flu Vaccine Production In 2008 Will Match 2007, But Strains Get Overhaul
The U.S. influenza vaccine market appears stable in terms of the amount of available product, but the nature of the product this year will be quite different
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A recent publication shows the ability to make high-affinity, virus-specific human monoclonal antibodies in a matter of weeks from antibody-secreting plasma cells. The research suggests, at least theoretically, that an antibody vaccine could be developed for any infectious disease, using blood from either immunized or infected individuals.
Vaccines generally are one of the few areas in pharmaceutical development where government incentives, science, and intellectual property are in alignment to favor commercialization. This is particularly true for flu vaccine, where recent events have drawn the attention of government and Big Pharma. That, plus the advent of new adjuvant technology and innovative manufacturing methods, signals opportunity for new players.
The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter