Production of commercial A (H1N1) vaccine using Vero cell culture technology
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Baxter has announced that it has completed testing and evaluation of the A (H1N1) influenza virus, and is now in full-scale production stage using its Vero cell culture technology.
Earlier in May, Baxter received an A (H1N1) strain from the US Centers for Disease Control and Prevention, and is working to deliver a pandemic vaccine for use as early as July.
Using its Vero cell technology, Baxter has received European Medicines Agency (EMEA) approval for a mock-up pandemic vaccine called CELVAPAN. The qualification, development and manufacturing processes, used in gaining mock-up licensure for CELVAPAN apply, as the company uses this new influenza A/H1N1 virus strain to produce a pandemic vaccine.
The CELVAPAN EMEA licensure supports fast track approval of a pandemic vaccine containing the H1N1 virus strain. Baxter will submit the vaccine for approval upon completion of initial manufacturing runs.
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