GUEST COLUMNISTS

• Metrics, Not Audits, Should Lead Vendor Accountability

  Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.

• Ask The Pros — The Latest In Upstream HCP Mitigation

  We asked leading experts how upstream interventions can reshape HCP control. Here’s what they shared. Answers have been edited for clarity.

• 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For

  2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.

• Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry

  GlycoNex's denosumab biosimilar development experience illustrates how a "just copy it" approach is an insufficient strategy in modern biomanufacturing.

• A Deeper Look At Pharma's Structural Supply Chain Vulnerability

  Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.

• Survey: SUS Insufficient For 40% Of Biopharma

  New data from BioPlan Associates suggests single-use systems adoption may be plateauing with single-digit growth rates.

• Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis

  Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.