Biosafety testing: biologics production verification with animal cell matrix preparation for the production of antibody-based drugs, protein-based drugs, virus-based drugs, cell therapy products and other biologics cell lines / strains, need to pass a comprehensive cell bank chracterization, bluk/lot release testing and viral clearance validation (biosafety testing) to help users and drug regulatory units to assess the safety of the product.

The test items are based on the Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, US Federal 9CFR, US Food and Drug Administration PTC (1993/1997/2010), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Q5A & Q5D for method development, which can meet the biopharmaceutical customers' requirements for dual filing of IND/BLA Chinese and US regulations, and at the same time can help the post-marketing commercial products to perform release testing.