Creutzfeldt-Jakob Disease and Blood Safety: Addressing the Risk, an Industry Perspective
Robert W. Kozak, Ph.D., Bayer Corporation, Berkeley, CA 94701
In 1995, in response to increasing uncertainties about the theoretical risk of CJD to life-saving plasma-derived products and the patients who depend on them, Bayer Corporation proactively developed a TSE/CJD research program. A scientific task force established an approach based on world-wide accepted principles to control and minimize any risk from potential adventitious agents. In addition to careful selection of raw materials, a sensitive Western blot assay was optimized to detect the disease marker (termed prion) and to determine the prion clearance capabilities of manufacturing processes. The western blot assay data provides similar clearance results to the rodent bioassay but in less than two days instead of the 8-14 months needed by the bioassay. The increased throughput of the western blot provides sensitive, reproducible data that increased the statistical confidence of the clearance data unattainable with the bioassay alone. The Bayer TSE/CJD program was reviewed with international experts in the field including the FDA to assure the approach and information generated was scientifically sound, and would provide missing scientific knowledge and additional safety to patients. Updates on the progress of the program were provided to FDA, world health authorities and consumer groups and recommendations obtained incorporated into the program. A brief description of the program and results will be given along with the partnership established with the FDA.