Guest Columns

  1. Deploying A Vendor Life Cycle Oversight Model 1/9/2026

    A practical guide for adding oversight, based on a hierarchy of metrics, to quality agreements to transform them into living, metrics-driven control instruments.

  2. Moving Leukopaks From GTP To GMP Is One Cell Therapy Trend To Watch In '26 1/9/2026

    Cell therapy stumbled in 2025. Solving the variability in starting material quality is critical to stabilizing manufacturing in 2026.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Allogeneic Cell Therapy's Success Hinges On Perfecting The Platform 12/29/2025

    The industry remains far from realizing a manufacturing platform with a repeatable, standardized process that can support broad clinical and commercial deployment.

  10. The Trends Shaping Clinical Trial Supply 12/22/2025

    Decentralized trials and biotech product needs are changing how investigational products reach patients. New market research reveals trends.