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StaphVAX News

October 16th, 2005 · No Comments

“StaphVAX was developed to prevent the most dangerous and prevalent strains of Staphylococcus (staph) aureus bacterial infections. This week, Nabi has announced the success of a StaphVAX consistency lots study, which was an open-labeled study testing the safety and immune response of three commercial scale lots of the drug, which was produced by the company’s contract manufacturer, Cambrex Bio Science Baltimore (NYSE:CBM) (Baltimore, Maryland).

In the study, StaphVAX was given to 354 healthy adults at three sites across the U.S. The data gathered demonstrated two major points–that StaphVAX can elicit high levels of anti-staphylococci antibodies and that it can be consistently and successfully manufactured. The data also showed that the manufacturing process is both well controlled and reproducible. While the Boca Raton site is still awaiting final FDA approval, the company expects no problem in receiving certification, and with dual production sites, it has ensured adequate capacity for the pending commercial launch of the drug.”

Breaking News: Favorable StaphVAX News Just What the Doctor Ordered as Nabi Completes $20 Million Florida Vaccine Plant, an Advisory from Industrialinfo.com

Tags: Research and Development

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