Featured Bioprocessing Editorial

1. What To Do About Process Drift In Your Biosimilar's Reference Product 5/22/2026

   Biosimilar development often reveals quality drifts in certain lots of the reference biologic. In most cases, quality changes are noncritical, but some drifts can impact CQAs.

2. 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.

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. 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.

6. 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.

7. 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.

8. Closing The MES Value Gap: Why Technology Isn't The Problem 5/14/2026

   Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.

9. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

   Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

10. CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO? 5/8/2026

    Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.