Navigating CAR-T Manufacturing: Compliance & Operational Complexities Unveiled

Join Nidhi Kotecha, Regulatory Affairs Program Director at the Gates Institute, as she explores the intricate landscape of Phase-I GMP manufacturing for CAR-T cell therapy. Discover the critical operational challenges researchers face in transitioning innovative therapies from the lab to the clinic. From regulatory compliance to technology transfer, Nidhi shares insights on maintaining product quality, managing variability, and ensuring safety. Tune in to understand how strategic decisions impact the journey of groundbreaking therapies and the future of immunotherapy!