Bayer Corporation

Bayer Healthcare LLC

Robert W Kozak

Douglas C Lee

Steve R Petteway

The invention provides a rapid, sensitive immunoassay capable of detecting and quantitating pathogenic protein to a level of 3 to 5 logs. The preferred immunoassay utilized is a chemiluminescent endpoint for a Western blot immunoassay. The invention has been successfully applied to track the clearance of pathogenic protein during production of proteins derived from plasma. It is particularly applicable and has been confirmed by bioassay to relate TSE infectivity to quantitative results on prion protein.

Detection of transmissible spongiform encephalopathy (TSE) protein employing a highly sensitive Western blot assay and chemiluminescent detection system

Transmissible spongiform encephalopathies (TSEs) are a class of fatal, neurodegenerative diseases found in many mammalian species. Human TSEs include kuru, Creutzfeldt-Jakob disease (CJD), and fatal familial insomnia. Non-human TSEs include sheep scrapie, bovine spongiform encephalopathy (BSE), feline spongiform encephalopathy, and chronic wasting diseases in elk and mule deer. These neurodegenerative diseases are caused by prions and display characteristic amyloid plaque deposition. The only known component of the infectious prion is an abnormal, disease-causing isoform of the prion protein (PrP), called PrP scrapie (PrP ). During a post-translational process, PrP is formed from the normal, cellular PrP isoform (PrP ). The scrapie isoform is less soluble, more proteinase-resistant, and more susceptible to aggregation than the wildtype protein. The claimed invention is directed toward a rapid, specific, sensitive, and quantitative method for the detection of TSE clearance from a plasma product utilizing a chemiluminescent Western blot immunoassay. This immunoassay format can detect picogram concentrations of PrP (proteinase resistant PrP fragment) and is linear over a 3-5 log range. The invention is useful for tracking the clearance of PrP during plasma manufacturing processes.

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Foster City, CA, United States of America

Robert W Kozak