Prion Clearance Studies
As detailed in the international guidance, investigations of the ability of a biopharmaceutical manufacturing process to remove or inactivate Transmissible Spongiform Encephalopathy (TSE) agents can provide prion safety assurances for the product. For any human or animal-derived product with the risk of prion contamination the purification steps must ensure elimination of the pathogen.
The first commercially available Western blot assay for use in prion reduction studies was developed by Dr Andy Bailey, now CEO and Director of Operations at ViruSure
Further, ViruSure is the only company offering the in vivo prion bioassay in Europe – the gold standard if you claim prion safety margins your product.
What our Clients SayMarcel Asper , Director Virus Lab, Biotest (Germany)
Over more than a decade we always got excellent and professional support and could therefore successfully finalize all Prion and Virus Validation studies with Virusure within projected timelines. Thank you very much.
Available Prion Clearance Studies
Although ViruSure is able to work with a variety rodent adapted prion strains, most studies are designed and performed using the 263K hamster adapted strain of Scrapie. This agent is a well-accepted model for TSE by the regulatory authorities.
Western Blot Testing Services
With the fully validated quantitative Western blot assay for prion protein, ViruSure performs investigational studies on the ability of manufacturing processes to remove or inactivate prions in compliance with EMEA, FDA and JMHLW requirements.
In Vivo Prion Bioassays
ViruSure operates a fully validated state-of-the-art BSL-2 facility equipped for working with prion animal models – the gold standard for prion titre determination.