Do you know what FDA is looking for in the cell therapy potency assays?
FDA published a guideline in Dec 2023 on CGT potency assay. We summarized the top 3 success factors for a good cell therapy potency assays are as follows.
1. Clear Mechanistic Link: Establish a clear link between the mechanism of action and the established potency assay. An example would be a specific tumor-associated antigen targeted cytotoxicity assay serving as an effective potency assay for tumor-killing cell therapies.
2. Robust Reference Materials: Qualifying reference materials is integral to the assay qualification process, ensuring reliability and consistency.
3. Systematic Production Process Control: Maintain systematic control over the production process. For instance, both the viral vectors and final cell therapy products are expected to have robust potency assays in the final IND package.
As the Center of Excellence of Cell Therapy, our scientists in our Worcester MA manufacturing and analytics team have more than 6 years of experience of cell therapy potency development, qualification and validation experience with more than 100 clinical cGMP cell therapy batches and more than 6 cell therapy potency assays developed and qualified.
What problem are you facing in your cell therapy potency assays?
We are ready and able to help you. Please call us at 1800 663 2528 or Contact Us online. Look forward to supporting you with developing qualifying robust potency assays.