Cell-Based Potency Assays: De-Risk Your Path To Patients With An Experienced CDMO
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This whitepaper outlines the growing regulatory emphasis on potency testing for monoclonal antibody (mAb) therapeutics and biosimilars, highlighting the need for phase-appropriate, mechanism-relevant bioassays to ensure safety, efficacy, and product consistency. It reviews ligand-binding approaches—ELISA and surface plasmon resonance (SPR)—for affinity and kinetics, and details cell-based potency assays that model key Fc-mediated effector functions, including ADCC, ADCP, and CDC, as well as FcRn and signaling-based mechanisms.
The author contrasts classical primary cell formats with genetically engineered reporter systems that improve reproducibility and suitability for cGMP release and stability testing and also addresses practical challenges in sourcing cells, optimizing culture and assay conditions, and establishing robust, sensitive endpoints—factors that often motivate outsourcing to experienced partners.
FUJIFILM Biotechnologies’ Bioassay Department can provide comprehensive CDMO solutions, offering routine cGMP analytics, custom potency assay development and validation, analytical cell banking, and integration of orthogonal data (e.g., SPR) to build a holistic understanding of mAb function.
This whitepaper outlines the growing regulatory emphasis on potency testing for monoclonal antibody (mAb) therapeutics and biosimilars, highlighting the need for phase-appropriate, mechanism-relevant bioassays to ensure safety, efficacy, and product consistency. It reviews ligand-binding approaches—ELISA and surface plasmon resonance (SPR)—for affinity and kinetics, and details cell-based potency assays that model key Fc-mediated effector functions, including ADCC, ADCP, and CDC, as well as FcRn and signaling-based mechanisms.
The author contrasts classical primary cell formats with genetically engineered reporter systems that improve reproducibility and suitability for cGMP release and stability testing and also addresses practical challenges in sourcing cells, optimizing culture and assay conditions, and establishing robust, sensitive endpoints—factors that often motivate outsourcing to experienced partners.
FUJIFILM Biotechnologies’ Bioassay Department can provide comprehensive CDMO solutions, offering routine cGMP analytics, custom potency assay development and validation, analytical cell banking, and integration of orthogonal data (e.g., SPR) to build a holistic understanding of mAb function. Fill out the form on this page to discover more.