Guest Columns

  1. Single-Use Standards Are Maturing, But The Process Remains King 1/13/2026

    The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.

  2. Mind The Potent Compounds When Retrofitting Facilities For ADCs 1/12/2026

    Antibody-drug conjugate manufacturing introduces significantly more risk to employees. Likewise, facility safety requirements are especially intense.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.