GUEST COLUMNISTS

• Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit

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

• Rethinking CQV In A Digital, Agile Manufacturing Landscape

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

• Will FDA's One-Day Inspection Pilot Stand The Test Of Time?

  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.

• A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight

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

• Why Contamination Control By Design Should Matter To Your CDMO

  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.

• Repeating Sanofi's Ballroom Design On Two Continents

  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.

• Closing The MES Value Gap: Why Technology Isn't The Problem

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