Guest Columns & From The Editor

  1. From "Live Drug" To Precision Tool: Redefining CAR T Safety 3/20/2026

    Through important chemistry and the right engineering, there’s new opportunity for CAR T therapeutics to target different forms of cancer with limited toxicity.

  2. 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.

  3. 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.

  4. 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.

  5. The Long Road To U.S. Vaccine Manufacturing 3/19/2026

    GeoVax CEO David Dodd sings the praises and is grateful for the program-enabling relationships he has in Europe. At the same time, he harbors lingering disappointment. From the outset of its formation, the biotech has desired to work with U.S.-based CDMOs.  But he says he will not give up. “One way or the other,” Dodd says, “GeoVax will have U.S.-based manufacturing.”

  6. Compliance, Costs, And Site Readiness In CAR-T Clinical Trials 3/19/2026

    Navigate CAR-T trial complexity: uncover key compliance, budgeting, and site readiness strategies to ensure safe, efficient, and successful patient care.

  7. 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.

  8. Managing Operational Challenges In CAR-T Clinical Trial Logistics 3/18/2026

    Coordinating CAR-T trials means managing tight timelines, cryogenic handling, staffing gaps, and chain-of-identity risks where even small missteps can delay care.

  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.