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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


BioReliance has extensive experience in developing and testing for TSE in biologicals.

 

 

  

What products and manufacturing processes are suggested for prion detection?

 

Examples of products for which TSE clearance (prion detection) studies have been performed include:

  • 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

 

BioReliance is one of the world’s leading CROs, offering prion detection assays aimed at enforcing a compliant GMP validation protocol.


Learn more about our TSE Clearance services – consult with BioReliance's staff to ensure your studies are designed to best suit your project needs.


Contact us by
clicking here.

 

What is TSE?

Prion diseases or transmissible spongiform encephalopathies (TSEs) are a group of rare progressive neurodegenerative disorders that can affect patients. TSE is caused by proteins that act like viruses called prions.


A prion can induce abnormal folding of normal cellular prion proteins in the brains of humans and animals, leading to brain damage.


TSE can be unknowingly transferred to patients in products-derived from animal tissues or from cell culture reagents. For this reason, we recommend prion detection studies for most biologicals.

 

Find the TSE clearance service you need - use the search tool to the right.

Contact a BioReliance scientist to find the TSE Clearance service you need by clicking here.