Regulatory Videos

  1. Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D. 12/12/2025

    On this week's episode of the Business of Biotech, Bruce Culleton, M.D., CEO at ProKidney, talks about moving from academic research to industry and the role a key mentor played in his career path.

  2. MES Apps Built For Speed And Seamless Integration 12/9/2025

    Digitize bioprocess workflows to achieve consistent, paper-free execution that deploys up to 66% quicker than traditional MES with a cloud-based, no-code platform built for single-use bioprocessing.

  3. Fill And Finish: Your Final Step Is Our First Priority 12/9/2025

    Fill and finish demands precision, compliance, and adaptability. Learn how flexible solutions and expert support can help you overcome complexity, reduce risk, and ensure quality in this final step.

  4. Engineering B Cells With Immusoft's Sean Ainsworth 12/5/2025

    On this week's episode of the Business of Biotech, Sean Ainsworth, CEO and Chairman at Immusoft, talks about transitioning from the research bench to entrepreneurship, his M&A experiences as a biotech founder, and why engineered B cell therapies offer a better, more patient-friendly administration for lysosomal storage diseases currently treated with enzyme replacement therapies.

  5. Developing Your Risk-Based Approach To Single-Use System Integrity 10/29/2025

    Explore how a holistic approach to single-use system integrity can strengthen contamination control, improve operational efficiency, and meet evolving regulatory expectations in manufacturing.

  6. Developing Antibodies To Block Neuroinflammation With MindImmune's Stevin Zorn, Ph.D. 10/20/2025

    In this episode of "Better Biopharma," host Tyler Menichiello is joined by MindImmune's president and CEO, Stevin Zorn, Ph.D. They discuss the development of the company's lead candidate, MITI-101, a monoclonal antibody designed to prevent peripheral immune cells from entering the brain and driving neuroinflammation linked to Alzheimer's disease.

  7. How AI and ML Drive iPSC Quality with Aspen Neuroscience's Thorsten Gorba, Ph.D. 10/7/2025

    In Episode 113 of Cell & Gene: The Podcast, Host Erin Harris is joined by Thorsten Gorba, Ph.D., of Aspen Neuroscience to explore how the company is advancing the field of cell therapy manufacturing.

  8. Engineering Bacterial Vector-Based Immunotherapies With OS Therapies' Paul Romness and Robert Petit, Ph.D. 10/7/2025

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by OS Therapies’ CEO, Paul Romness, and chief medical and scientific officer, Robert Petit, Ph.D. The three discuss the development and manufacturing of the company’s lead asset, OST-HER2, a Listeria-based immunotherapy for osteosarcoma.

  9. Liquid Phase Peptide Synthesis: Regulatory, Analytical, And QC Perspectives 10/3/2025

    Discover how Liquid Phase Peptide Synthesis (LPPS) uses traditional reactors to create more efficient and sustainable peptide manufacturing. Learn about key analytical and quality control considerations.

  10. Process Intensification Strategies For Smarter Biomanufacturing 10/1/2025

    Explore how biopharma leaders are using process intensification to modernize facilities, cut costs, and increase yield with practical strategies and real-world case studies.