Industry Insights

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight 5/18/2026

   A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.

8. 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.

9. Repeating Sanofi's Ballroom Design On Two Continents 5/15/2026

   Moveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.

10. Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not 5/14/2026

    Tokyo Institute of Technology. London Business School. ETH Zürich. What do these institutions – and a biotech based in Mulhouse, France – have in common? Matthieu de Kalbermatten, CEO of CellProthera. His international experience adds up to this: Build an internal quality (cGMP) organization; become the master of the processes you create for your therapy, before moving to external help; then select your CDMO carefully – maybe just prior to Phase III.