In the mid 1990s, concern began to develop about transmissible spongiform encephalopathies (TSEs), which are a collection of fatal neurodegenerative diseases. In response, Talecris Biotherapeutics developed assays to detect prion proteins in vitro and investigated the removal of prion proteins and infectivity in scaled-down purification steps that lead to therapeutic proteins.

Talecris Biotherapeutics' commitment to safety has resulted in:

Development of the patented Western blot assay (PDF) which is used to confirm the removal of pathogenic prion proteins during the manufacturing process for human plasma-derived products.1 Demonstration of clearance of scrapie prions and human vCJD, which has correlated with infectivity clearance as determined by bioassay.2

Commitment to Safety
Because of Talecris Biotherapeutics' commitment to maximizing the safety of biological products, we made our prion detection technology available to manufacturers of other biological products. This was done to help improve the safety of biological products across the industry and to provide patients with increased peace of mind.

Screening Method Virus Reduction Talecris Research

All of the products below are made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. The physician should discuss the risks and benefits of these products with the patient, before prescribing or administering to the patient.

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