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Prion Detection & TSE Clearance

Prion Detection and Transmissible Spongiform Encephalopathies (TSE) Testing studies are required to demonstrate downstream processes safely inactivate prions from biologicals derived from animal systems. TSE clearance is required by regulatory authorities for investigational new drug (IND) submission.

Prion detection affects multiple manufacturing endpoints including:

  • Biological Safety
  • Product Purity
  • Product Quality
  • Therapeutic Efficacy

We have extensive experience in developing and testing for TSE in biologicals:

  • Human and bovine blood products and coagulation factors
  • Equine and ovine blood products
  • Human and animal urine derived products
  • Tissue derived products
  • Monoclonal antibodies
  • Recombinant proteins
  • Medical devices (including collagen-derived products)
  • Enzymes
Contact an expert about your Prion Detection & TSE Clearance needs

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