Industry Insights

  1. What Reliance, Annex 1, And AI Mean For The Future Of GMP 5/29/2026

    EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

  2. Advancing Autologous Stem Cell Engineering For Diabetes And Vision Loss 5/28/2026

    Advances in autologous stem cell and biomaterial engineering are transforming the future of regenerative medicine by enabling scalable, patient-derived therapies.

  3. Applying Contamination Control By Design: A Practical Guide For CDMOs 5/26/2026

    This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

  4. Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit 5/22/2026

    The missing link between data generation and unleashing it to power automation often lies in well-governed cloud infrastructure.

  5. Rethinking CQV In A Digital, Agile Manufacturing Landscape 5/21/2026

    While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

  6. CGT Manufacturing Shifts From Capacity To Strategy 5/21/2026

    As manufacturing overcapacity reshapes the CGT landscape, success now depends less on access to capacity and more on strategic alignment across development, regulatory readiness, and long-term 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. The Next Frontier In Women's Cancer Care: Combining Cell Therapy With Immuno-Oncology 5/19/2026

    The convergence of engineered cell therapies and immuno-oncology represents a significant step forward in the quest to improve outcomes for ovarian cancer patients.

  9. Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease 5/19/2026

    Autologous intradiscal therapy integrates delivery and biology into one system, highlighting the potential of cell therapies in complex, localized disease environments.

  10. Why Contamination Control By Design Should Matter To Your CDMO 5/18/2026

    EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.