Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. CGT Industrialization Starts With CDMO Alignment 12/19/2025

    Fragmented processes are stalling progress. By aligning CDMOs through transparency and standards, developers can move past the COGS obsession and stabilize the supply chain.

  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. November 2025 — CDMO Opportunities And Threats Report 12/16/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  10. 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?