Cell-Based Assays in a GMP Environment: Approaches for Clinical and Commercial Stability Studies
April 17, 2018 - Online ON CA
This presentation will highlight the approaches used in developing consistent cell-based potency assays meeting regulatory expectations (USP <1032> and <1033>) and are suitable for cGMP stability testing. In addition, a phase appropriate potency method development and qualification/validation strategy will be discussed. Practices in support of successful cell-based assay transfer and long-term maintenance of the assay in the QC laboratory will be presented.