Biopotency Testing

Potency testing is critical for the regulatory approval and lot release of biologics. In particular, FDA and EMA guidelines mandate that customized potency assays be developed and validated prior to clinical trials. This testing is commonly done through in vivo or in vitro bioassays, as advised by global regulatory agencies, to demonstrate product efficacy and manufacturing consistency. Because potency assays are essential in verifying product quality, it is critical to choose a testing partner that understands your development needs.

Our services are available for:

• mAb
• Biosimilar mAb
• Non-mAb biologic
• Non-mab biosimilar
• Viral Vector
• Cell based therapy

We work with you to design custom cell based assays that are regulatory compliant, reliable, and relevant to your specific biologic. Our expertise extends many functional and ligand binding bioassays for recombinant proteins including:

• Cytotoxicity
• Proliferation
• Toxin Neutralization Assays
• Antibody Binding
• Reporter gene expression
• Cytokine production