Evolution of a Cell Based Potency Assay from Early to Pivotal Clinical Stage
Time: 12:30 pm
day: Conference Day One - Track A - AM
Details:
• Early assay development strategy with a focus on model cell lines and controls
• Transformation in the assay from supporting process development to drug product release and stability
• Challenges in developing pivotal stage assays in cell therapy and use of matrix potency approach for complex cell therapy products
