GUEST COLUMNISTS

• Applying Contamination Control By Design: A Practical Guide For CDMOs

  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.

• What To Do About Process Drift In Your Biosimilar's Reference Product

  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.

• 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.