Viral Safety Testing

Guidances on pharmaceutical development insist on the necessity to consistently deliver the intended performance of the products. Using living cells as part of the manufacturing process is a challenge. Homogeneous, large cell banks are the keys to meet these exacting requirements.

- Cell based assays/potency assays during development - Immunogenicity, TK/PK, ADA and neutralizing Antibody Testing - Immunotoxicology studies - Sample pre analytics: serum/plasma isolation, PBMC isolation & storage - Biobanking - Read-outs: ELISA, ECLIA, Flow cytometry, ELISpot, HAI, proliferation...

Viral Clearance studies are a critical preventative measure to ensure the security of biological products. Accidental viral contaminations can unfortunately happen during the manufacturing process. The process must comprise manufacturing steps which reduce contamination of the final products to an acceptab...