Wednesday, July 5

Baxter Begins Clinical Studies On H5N1 Vaccine



This is pretty wild what Baxter, a Deerfield Il. based company, is doing with it's vero-cell technology. I will just copy and paste it since I could never explain it.

(GEN)The study is being conducted with several hundred healthy adults in Austria and Singapore using the fully inactivated wild-type H5N1 strain A/Vietnam/1203/2004. Four different antigen concentrations ranging from 3.75mcg to 30mcg are being tested in formulations with and without alum as adjuvant.
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Baxter is developing both seasonal (or inter-pandemic) and pandemic influenza vaccines based on the company's proprietary vero-cell technology, which has the potential to significantly reduce production time compared to traditional vaccine production methods that use embryonated hens' eggs. The company is already licensed to produce vaccines at its commercial scale cell- culture vaccine manufacturing facility in Bohumil, Czech Republic, which is GMP approved and fully validated to Biosafety Level Three (BSL-3).

Cell-based systems for production of vaccines offer a number of potential benefits over more traditional egg-based systems. Baxter's vero-cell technology is capable of producing high yields of influenza virus without the addition of any animal-derived serum. Through the company's research and development work, Baxter has been successful in growing wild-type virus at pilot and commercial scales using its unique vero-cell technology. This means the company is currently capable of manufacturing pandemic vaccine without having to wait for high-growth or attenuated virus reassortants normally used when vaccine is produced in eggs. The requirements for such reassortants may involve considerable delay in vaccine production in the event of a pandemic.