Regulatory Videos

  1. Filtration Unfiltered: Technology To Meet New Bioprocessing Challenges 9/29/2025

    Explore how filtration strategies are adapting to diverse molecule pipelines, regulations, and sustainability targets with insights into process intensification and the technologies shaping the future.

  2. How Single-Use Technologies Are Simplifying Contamination Control 9/10/2025

    Learn how single-use technologies help reduce contamination risks and support compliance with updated EU GMP Annex 1 guidelines for aseptic processing and sterile drug manufacturing.

  3. Improving Cardiovascular Outcomes With Immediate Therapeutics' Atul Deshpande, Ph.D. 8/27/2025

    On this week's Business Of Biotech episode, Atul Deshpande, Ph.D., CEO at Immediate Therapeutics, talks about partnering with American cities to conduct clinical trials during ambulance rides to the hospital, with the goal of preserving heart function and reducing mortality related to acute cardiovascular events, including heart attacks.

  4. What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago 8/27/2025

    This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with regulatory affairs expert Daniela Drago, Partner, NDA Partners, about how shifting FDA and CBER priorities under the current administration could influence the trajectory of cell and gene therapy development.

  5. Delivering Biologics To The Brain With Adaptin Bio's Michael Roberts, Ph.D., and Duke University's Mustafa Khasraw, MD 8/26/2025

    In this episode of "Better Biopharma," host Tyler Menichiello is joined by Adaptin Bio's CEO, co-founder, and president, Michael Roberts, Ph.D., and Duke University's Mustafa Khasraw, MD to discuss Adaptin's Brain Bispecific T-cell Engager (BRiTE) platform.

  6. Barriers, Breakthroughs, and Building Access in Pediatric CGTs with Bambi Grilley, Ph.D. 8/21/2025

    This is Episode 3 of "FDA Fridays," a 4-week special series from Cell & Gene: The Podcast. Host Erin Harris talks to Bambi Grilley, Ph.D., Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine and Chief Regulatory Officer for ISCT, a leading expert at the forefront of pediatric cell and gene therapy.

  7. Defining Product Roles and Navigating FDA Approval with Monika Swietlicka 8/13/2025

    In Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, Host Erin Harris talks to regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group to discuss key strategies and challenges in navigating FDA regulation for cell and gene therapies.

  8. Developing An In Vivo CAR-T With Interius BioTherapeutics' Sianny Christanti and Babu Medi, Ph.D. 8/12/2025

    On this episode of Better Biopharma, Interius BioTherapeutics’ Sianny Christanti and Babu Medi, Ph.D., explain how the company is re-engineering a lentiviral vector to enable INT2104, its off-the-shelf, in vivo CAR T-cell therapy. They discuss the vector's design and its manufacturability, as well as the analytical and regulatory challenges of bringing this first-in-human therapy to the clinic.

  9. Unfiltered: The Great PFAS Debate 8/7/2025

    Explore the global concern over persistent “forever chemicals” linked to health and environmental risks, as well as learn about regulatory debates, global restrictions, and why urgent action is needed.

  10. Streamline Production With A Final Filling Single-Use Set 8/7/2025

    Streamline your production with a Final Filling Single-Use Set that installs in under 10 minutes to eliminate cleaning and sterilization while ensuring Annex 1 compliance and full customization.