BioOutsource — cGMP compliant biotesting
Useful Links
CPMP Position Statement on DNA and Host Cell Proteins (HCP) Impurities, Routine Testing Versus Validation Studies
ICH Q5D. Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for the Production of Biotechnological/Biological Products
Position Statement on the Use of Tumorigenic Cells of Human Origin for the Production of Biological and Biotechnological Medicinal Products.
