GUEST COLUMNISTS

• Generative AI Can Write The Code, But Who Builds In The Quality?

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

• UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk

  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.

• February 2026 — CDMO Opportunities And Threats Report

  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.

• COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy

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

• All The Ways Global Biopharma Still Grapples With Annex 1

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

• FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address

  For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework.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

• Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables

  A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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

• Where Contamination Control Really Breaks Down In Practice

  Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.