Cell and Gene Regulatory

  1. Disciplined CGT Will Win On 2026 Regulatory Flexibility 1/29/2026

    Wilson Bryan, M.D., and Daniela Drago, Ph.D., RAC, joined our our first Cell & Gene Live of 2026 to unpack what a more mature era of regulatory oversight means for sponsors.

  2. Putting Pressure On CDMOs With Herman Bozenhardt 1/27/2026

    In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance.

  3. Drug Product Development: Preclinical To Commercial 1/26/2026

    Watch a unified roadmap for drug product development, outlining phase‑appropriate studies, QTTP importance, and key requirements from preclinical stages through commercialization.

  4. Subvisible Particle Analysis For End‑To‑End Quality 1/26/2026

    See strategies for precise subvisible particle analysis, covering regulatory expectations, method validation, and controlling variability when transitioning workflows from R&D to GMP environments.

  5. Building A Path To A Successful AAV Product 1/26/2026

    See state‑of‑the‑art analytical methods for AAV characterization, key quality attributes to monitor, and approaches for measuring infectivity and full‑to‑empty capsid ratios.

  6. Lyo‑Modelling For Risk Reduction And Process Insights 1/26/2026

    Use lyophilization modelling to optimize freeze‑drying, boost product quality, and lower commercialization risks through predictive insights, robustness analysis, and deeper process understanding.

  7. Detecting Particles In Biologic And CGT Drug Products 1/26/2026

    Identify and characterize visible and subvisible particles that can form during biologic and cell or gene therapy development.

  8. Ensuring Viral Safety Through Multiplexed Adventitious Virus Detection 1/23/2026

    Gain a targeted look at multiplex digital PCR that detects diverse human viral contaminants with speed, sensitivity, and precision. Learn how high‑multiplex workflows support QC needs.

  9. In Vivo's Biggest Threat — Comparison To Old Models 1/23/2026

    In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.

  10. 2026 Regulatory Roadmap 1/22/2026

    Cell & Gene’s Chief Editor, Erin Harris, was joined by two of the field’s most trusted experts, Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT), and Daniela Drago, Ph.D., RAC, Partner at NDA Partners, to translate regulatory expectations into practical strategies for CGT sponsors as they design trials, plan filings, and position programs for global success.