Analytical transfer of cell-based potency assays: Challenges from experience

CASSS US Bioassay 2023 -- The transfer of cell-based potency methods is a necessary requirement to support the CMC drug development lifecycle. Method transfer may be between labs within the same company or externally to one or even multiple external sites (e.g., CDMOs, CROs). There are many potential problems that can arise during the transfer process, but the risk can be significantly reduced with thorough due diligence and a well-documented, step-wise, risk-based approach. Even with the best intentions and good planning, be prepared for obstacles that can challenge the most experienced!