Taming the Living System for Transferring Cell-Based Potency Assays To QC & Integrating Intelligence Into HPLC Method Development & Validation
- Provide comprehensive, hands-on training for QC analysts in aseptic technique and cell culture to ensure consistent andsterile handling of living cell lines, minimize contamination events, and ensure the reliability of the potency data generated at the QC site
- Co-develop detailed and unambiguous method instructions with the receiving lab to eliminate variability introduced by differences in interpretation or execution, ensuring the assay performs identically at both the development and QC sites
- Establishing a joint trending program for key assay performance indicators during transfer to identify and troubleshoot any drift or performance issues, maintaining the long-term robustness and GMP compliance of the potency method