Outsourced Pharma Editorial

  1. 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.

  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. 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.

  7. 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    For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework.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.

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    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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

  9. Advising The Biotech C-Suite To Reconsider Quality 3/16/2026

    “I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

  10. The Jones Act Hurts U.S. Pharmaceutical Manufacturing 3/13/2026

    The Jones Act punishes U.S. pharmaceutical manufacturing. It may have taken a modern-day war, one much involved with the free navigation of commercial shipping, but after more than 100 years navigating a policy of protectionism – and fear of competition – are we are again waiving the Jones Act (for 60 days). Chief Editor Louis Garguilo says let’s not temporarily waive it. Sink the Jones Act forever.