Cell and Gene Commercialization

  1. How Strategic CMC Planning Drives Cell Therapy Success 10/7/2025

    CMC is essential for cell therapy success, with FDA CRLs often due to CMC gaps; early strategic planning and robust controls reduce risks and accelerate market approvals.

  2. Scaling Allogeneic NK Cell Therapies 10/1/2025

    In this segment of Cell & Gene Live, Building the Future of Cancer Immunotherapy Through Allogeneic NK Cell Innovation, Tracy Ryan, Co-Founder and Chief Communications Officer of NKore BioTherapeutics, highlighted the allogeneic, off-the-shelf nature of their NK cell therapy. Raphael Ognar, President, CEO, and Co-Founder of NKILT Therapeutics expressed strong confidence that NK cell therapies can be produced at a fraction of the cost of autologous treatments, making them widely accessible and commercially viable.

  3. Driving Prostate Cancer Innovation Through Immunotherapy With OS Therapies' Dr. Robert Petit 9/26/2025

    OS Therapies' Dr. Robert Petit discusses the evolving role of immunotherapy in prostate cancer.

  4. A Study In Optimizing Late-Stage Processes With QbD, DoE 9/26/2025

    Nobody wants to redesign analytical process profiles when a market approval is within reach, but what about when a last-lap QbD exercise could bring real benefit?

  5. On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D. 9/25/2025

    DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.

  6. Navigating Commercial Logistics For CGTs: A Roadmap To Scalable, Patient-Centered Success 9/24/2025

    The commercialization of cell and gene therapies requires a precise and resilient logistics model that can adapt to rapid demand and global expansion while maintaining a patient-first approach.

  7. Building The Future Of Cancer Immunotherapy Through Allogeneic NK Cell Innovation 9/18/2025

    As the cell therapy space evolves beyond T cells, allogeneic natural killer (NK) cell therapies are emerging as a scalable and accessible approach in cancer immunotherapy. Cell & Gene's Chief Editor, Erin Harris, welcomed experts Raphael Ognar, President, CEO, and Co-Founder of NKILT Therapeutics, and Tracy Ryan, Co-Founder and Chief Communications Officer of NKore BioTherapeutics, for a detailed discussion exploring how their teams are advancing the field through distinct yet complementary strategies. The dynamic discussion highlighted the scientific innovation, technological differentiation, and patient-centered vision driving the next generation of allogeneic NK cell therapies, and why now is the critical moment to deepen research and exploration into novel NK platforms.

  8. 2024 Cell And Gene Therapy Report: Advancing The Future Of Medicine 9/2/2025

    Cell and gene therapies offer hope for cures, but face significant barriers to broader patient access. Find out how industry leaders are working to overcome these challenges.

  9. Navigating Commercial Logistics: Key Considerations For Emerging CGT Manufacturers 8/27/2025

    A successful cell and gene therapy launch requires a logistics strategy that keeps patients at the center, plans for disruptions, and prepares for future growth and global expansion.

  10. Precigen Secures FDA Approval For PAPZIMEOS And Redefines RRP Treatment 8/27/2025

    Precigen has received FDA approval for PAPZIMEOS, the first therapy for recurrent respiratory papillomatosis, marking a major advance in patient care.