Guest Columns

  1. Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign 3/27/2026

    The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

  2. Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity 3/27/2026

    Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.

  3. Navigating GMP Biosafety Challenges In ATMP Manufacturing 3/26/2026

    BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance.

  4. Generative AI Can Write The Code, But Who Builds In The Quality? 3/23/2026

    Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

  5. UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk 3/20/2026

    Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

  6. February 2026 — CDMO Opportunities And Threats Report 3/20/2026

    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.

  7. COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy 3/20/2026

    Problems emerge when development, manufacturing, and clinical priorities fail to converge in cell and gene therapy development.

  8. All The Ways Global Biopharma Still Grapples With Annex 1 3/19/2026

    Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

  9. FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address 3/17/2026

    For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

  10. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.