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The Center for Biologics Evaluation and Research (CBER) licensed Monoclate late in 1987, the first blood product purified by biotechnological techniques, an antihemophilia factor. This was produced from normal human plasma with monoclonal antibodies to extract Factor VIII:C from plasma. This treated hemophilia A, which affects more than 20,000 patients at that time.

The development and licensing of recombinant Factor VIII in 1992 and 1993 eliminated the possibility that the nation’s 10,000 suffering from hemophilia A would have to face the possibility of the transmission of hepatitis or AIDS. Recombinate was the first, licensed in Dec. 1992, and Kogenate received its license in the following February.

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