Cell and Gene Regulatory

31. The Advantages Of Off-The-Shelf GMP iPSCs With A DMF 6/2/2025

    Learn how off-the-shelf, GMP-grade iPSC lines with a Drug Master File (DMF) can accelerate cell therapy development, streamline regulatory approval, and reduce time and cost to clinic.

32. Biosafety Testing 6/2/2025

    Biosafety testing ensures biologics' safety and quality but faces challenges like cost, time, and technical complexity. Proper planning and regulatory compliance are key to success.

33. Accelerating Cell Therapy Development, Manufacturing Workflows 5/30/2025

    Realizing the full potential of modern cell therapies requires optimizing every stage of the process. Explore how advanced solutions can accelerate your development and manufacturing pipeline.

34. Opening Possibilities In Glycosylation 5/29/2025

    Achieving desired glycosylation for therapeutic proteins can be difficult. Explore innovative approaches to optimize this critical quality attribute.

35. Psychedelics For Mental Health Disorders With atai's Srinivas Rao, M.D., Ph.D. 5/28/2025

    On this week's Business of Biotech episode, Dr. Srinivas Rao, co-founder and CEO at atai Life Sciences, explains how his engineering background led him to the development of psychedelic compounds for treating depression, anxiety, and other mental health disorders. Internal drug development efforts at atai are focused on short-duration psychedelics that can work within existing healthcare infrastructure, with the potential to transform the treatment of mental health disorders.

36. Navigating CMC Regulation For Plasmid DNA In Gene Therapy 5/28/2025

    Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.

37. Navigating Regulatory Complexity In CGT Development, Commercialization 5/28/2025

    To successfully commercialize cell and gene therapies, understanding evolving US regulatory mandates is key. Consider these strategies to avoid delays and ensure compliance.

38. Regulatory Challenges And Future Outlook For iPSC Therapies 5/23/2025

    In this part of our discussion during the Cell & Gene Live, Unlocking the Potential of iPSC Therapies in Regenerative Medicine, Julie Allickson, Ph.D., Chief Technology Officer at Mayo Clinic's Center for Regenerative Biotherapeutics and Erin Kimbrel, Ph.D., Head of Cell & Gene Therapy Research at Astellas discussed key regulatory challenges for iPSC-based therapies, including donor cell sourcing, genetic modification risks, and long-term safety concerns like tumorigenicity.

39. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

    The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

40. Why Better Manufacturing Is the Key to Unlocking Cell Therapy's Full Potential 5/22/2025

    Emerging technologies are beginning to address the complex manufacturing challenges that have limited the scalability and accessibility of CAR-T and other cell therapies.