Guest Columns

  1. New USP Research Shows MAM As Alternative To Conventional Methods 1/9/2026

    Results show the multi-attribute method provided superior specificity and detected molecular modifications far better than the status quo.

  2. Metrics, Not Audits, Should Lead Vendor Accountability 1/9/2026

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

  3. Ask The Pros — The Latest In Upstream HCP Mitigation 1/5/2026

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

  4. 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For 1/5/2026

    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.

  5. Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry 1/5/2026

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

  6. A Deeper Look At Pharma's Structural Supply Chain Vulnerability 12/31/2025

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

  7. Survey: SUS Insufficient For 40% Of Biopharma 12/30/2025

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

  8. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

    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.

  9. Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing 12/15/2025

    How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?

  10. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.