GUEST COLUMNISTS

• Beyond The Plate Count: How To Build A Defensible Environmental Monitoring Trend Review

  Determining whether a drug manufacturing environment is stable, drifting, or developing a recurring loss-of-control signal requires integrated trend evaluation.

• What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI

  The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.

• How Is Your Glass Supplier Adapting To Europe's Energy Crisis?

  Europe's glass manufacturers, including those making pharmaceutical lab glassware, have experienced a series of energy shocks. Many have adopted sustainability practices.

• Can Peptide Mapping Predict Intact Antibody PTM Distributions?

  Peptide mapping quantifies modification at individual sites, but the same site-level results can correspond to different distributions across intact molecules.

• The EU Overhauls Pharma Laws: What You Need To Know

  On Sept. 18, the Council of the EU published the almost-final text of a major overhaul of the EU pharmaceutical laws. The final binding text is expected to be published very soon.

• An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?

  FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

• Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty

  Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.