Viral & Prions Safety: Assess the Risk Now!
Viral & Prions Safety (viral inactivation & viral clearance) including the prions (TSE agent) risk is a major issue for biologics (peptides/proteins, gene therapy, cell therapy, etc.) as well as for blood derivative products.
The first step is to assess the risk on dossier and then, if necessary, to address the experimental phase.
Available methodologies used are for viruses, qPCR or qRT-PCR, infectivity assays and for prions, an in vitro approach using an ultrasensitive western blot and in vivo (bioassay) using the reference model of hamsters infected with the scrapie 263K strain or murine models closer to the risk associated with the variant Creutzfeldt-Jakob Disease (CJD) such as the 6PB1 strain, a BSE strain adapted to mouse.On this topic, Bertin Pharma collaborates with Texcell and Voisin Consulting.