Establishing Robust Potency Assays to Overcome Donor Variability & Deliver Consistent Global Cell Therapy Products
2:15 pm - Tuesday 8th December 2026
- Qualifying donors, reagents, manufacturing processes and in vitro assays to build FDA-approved potency assays that ensure consistent product release across batches
- Leveraging 10 years of clinical correlations and potency assay development to demonstrate safety, efficacy and reproducible performance independent of donor variability
- Implementing globally reproducible potency testing frameworks to support regulatory approval, commercial scalability and manufacturing consistency across international sites
