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' ongoing commitment to maximizing the safety of all biological products, we made our prion detection technology available to manufacturers of other biological products. This was done in an effort to improve the safety of biological products across the industry and to provide patients with increased peace of mind.
References:
|
1. |
|
Lee DC, Stenland CJ, Hartwell RC, et al. Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods. 2000;84(1):77-89.
|
| 2. |
|
Lee DC, Stenland CJ, Miller JL, et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion. 2001;41(4):449-455.
|
|