Cell and Gene Regulatory

  1. Streamline Global Regulatory Submissions 5/21/2026

    Discover a more streamlined approach with one accountable partner supporting regulatory submissions globally.

  2. Planning For Scale-Up 5/21/2026

    From rapid early-stage production to scalable commercialization, discover the packaging and continuity challenges companies face as they prepare for launch.

  3. The Framework For Containment In A Cleanroom 5/20/2026

    ISO classification decisions shape cleanroom design. Learn how early alignment between process needs, biosafety, and classification can reduce redesign risk while supporting scalable environments.

  4. Timing And Data Are Critical To Winning BTD For Rare Disease Drugs 5/20/2026

    Breakthrough Therapy designation (BTD) can accelerate rare disease drug development—but timing and evidence are everything. Learn how to position your program for FDA success.

  5. Why Regulatory and Manufacturing Strategy Must Start Together 5/19/2026

    In this concluding segment of our Cell & Gene Live, “Distributed Manufacturing for CGT: Rent, Lease, or Buy in an Era of Overcapacity?,” experts Emily Moran, Founder, 3LB Consulting, LLC and Sugu Patro, Ph.D., Senior Vice President Global Process Development at Kite, a Gilead Company, our panelists explored why manufacturing and regulatory strategy can no longer operate in silos, emphasizing that alignment across CMC, regulatory planning, financing, and process development must begin at the earliest stages of asset design.

  6. Safeguarding Biologic Quality And Performance 5/19/2026

    A science‑driven roadmap, from QTPP to QbD and phase‑appropriate strategies, helps ensure biologics stability, manufacturability, and a smooth path to successful commercialization

  7. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

    FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

  8. Validation Challenges Facing Advanced Single-Use Technologies 5/18/2026

    In this episode of "Better Biopharma," host Tyler Menichiello is joined by BioPlan Associates’ director of research, Katrina Cordovado, as well as Joshua Nelson, Ph.D., a senior material qualification specialist at Takeda, and Paul Priebe, a consultant and single-use expert, to continue their conversation from the Bioprocess Online Live event, "Closing The Adoption Gap For Advanced Single-Use Materials."

  9. Plasmid-Free DNA Platform For Better Starting Material 5/18/2026

    Optimized synthetic DNA enables scalable gene and RNA therapies with improved stability, expression, and delivery, supporting advanced applications across viral, non-viral, and vaccine platforms.

  10. Gene To GMP, Translating Concept Into Cure 5/18/2026

    An integrated platform unites synthetic DNA production with advanced therapy development and GMP manufacturing, streamlining workflows while improving speed, scalability, and control.