In this In the Zone podcast, we talk to Vibhor Gupta, Associate Director, Business Operations (Cell & Gene Therapy) at Absorption Systems (PA, USA), about the importance of robust, reliable and accurate potency assays for cell and gene therapy products. Gupta discusses the significance of regulatory requirements and some of the major roadblocks encountered along the development route.
Q Please introduce yourself, your research background and your work at Absorption Systems
Q What is a potency assay in terms of cell and gene therapy products and why is it critical?
Q How early should you start looking into working on potency assay development?
Q What are the major roadblocks with potency assay development, qualifications and validation?
Q What are the regulatory requirements for a potency assay for different phases of a clinical study?
Q What services do Absorption Systems offer that can help with the development of potency assays?