Bayer BP receives FDA approval for manufacturing processes

BT Catalyst,  Oct-Nov, 2002  

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Bayer Biological Products (BP), with facilities in Research Triangle Park and Clayton, has received U.S. Food and Drug Administration (FDA) approval for additional processes used in the manufacture of Kogenate[R] FS for hemophilia A.

The FDA approved BP's use of six, 200-liter fermentors at its Berkeley, Calif., manufacturing facility. Twice the volume of current technology, the fermentors will grow hamster kidney cells modified to produce human factor VIII, the blood protein missing in hemophilia A patients.

The increased production capacity will help BP reduce the significant shortages of Kogenate FS cited by the Hemophilia Federation of America.

"Our commitment to providing reliable supplies of Kogenate FS is stronger than ever, and our releases are continuing to increase," said Dr. Gunnar Riemann, president of the division.

For more information visit the company's Web site at www.bayerbiologicals.com.

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