FDA approves Bayer manufacturing processes

Bayer Biological Products (Bayer BP) has been granted FDA approval for additional processes used in the manufacture of its antihaemophilic product Kogenate FS. Specifically, the FDA approved Bayer BP's use of six 200l fermentors at its manufacturing facility in Berkeley, California. The 200l fermentors – twice the volume of the fermentors currently utilised – are used to grow hamster kidney cells that have been modified through advanced recombinant technology to produce human factor VIII.

This approval enables Bayer BP to expand production capacity, as Kogenate FS manufactured using these fermentors can be released for use in the US marketplace. Further, the approval creates additional momentum for Bayer BP to achieve its highest quarterly releases of recombinant factor VIII by spring 2003.

The FDA also informed Bayer BP that responses and corrective actions following the March 2002 Berkeley inspection are acceptable. These communications reinforce findings of compliance by Canadian and European regulatory authorities following their inspections earlier this year.

Dr Gunnar Riemann, executive vp, Bayer Corporation, and president, Bayer BP Division, said: 'Our commitment to providing reliable supplies of Kogenate FS is stronger than ever, and our releases are continuing to increase. This approval is one of several positive communications received recently from the FDA, and is extremely important to us and to the community of patients we serve.'