Cell and Gene Regulatory

  1. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

  2. Scaling MSC Therapies To GMP: The Variability Challenge 8/6/2026

    Scaling stem cell therapies hinges on managing biological variability. Learn how automated 3D processing, defined media, and robust analytics drive predictable development.

  3. Manufacturing Readiness: Why Compliance Is Won Or Lost On The Floor 8/6/2026

    Achieve continuous regulatory readiness by embedding ALCOA++ compliance directly into manufacturing workflows to eliminate paper-based documentation risks.

  4. Your Comprehensive Guide To Navigating Regulatory Convergence, Continuous Audits, and AI-Driven Compliance 8/6/2026

    Stay ahead of FDA QMSR, EU GMP, and AI regulations by adopting continuous audit readiness, ALCOA++ data integrity, and closed-loop workflows for global compliance.

  5. A 50-Point Self-Assessment And Regional Comparison Tool For Quality Teams 8/6/2026

    Global quality standards are increasingly aligned across markets. Discover how a unified compliance framework satisfies international mandates and improves operational audit readiness.

  6. How Baby KJ Is Ushering In A New Era In CRISPR Medicine 8/5/2026

    A personalized gene-editing therapy was developed in months, showcasing how collaboration, manufacturing innovation, and regulatory alignment can accelerate treatments for rare diseases.

  7. Expand Trial Footprints Without Expanding Cryopreservation Risk 8/3/2026

    Transitioning from fresh to frozen starting material stabilizes cell therapy inputs, but isolated workflows introduce risk. Integrated logistics safeguard quality as trial footprints expand.

  8. When Local Variation Becomes Global Risk In Phase III 8/3/2026

    Late-stage therapy trials demand strict execution. Learn how local handling variations escalate into global risks and how early standardization safeguards therapeutic integrity and compliance.

  9. Regulatory Readiness Is Built Early 8/3/2026

    Building regulatory readiness early in cell and gene therapy development protects product integrity, prevents costly delays, and secures long-term program viability.

  10. What Will It Actually Take To Build A Resilient Global Vaccine Supply Chain? 8/3/2026

    U.S. funding cuts could leave 75 million children without routine vaccines. Five supply chain leaders explain what resilience actually requires and what's at stake if the sector fails to act.