Featured Outsourcing Editorial

  1. FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing 4/22/2026

    The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

  2. Validating Candel's BLA-Ready Analytics Profile 4/22/2026

    The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.

  3. Mapping Candel Therapeutics' Sprint To The BLA Finish Line 4/22/2026

    Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.

  4. The Hidden Operational Cost Contained In Every Small Molecule Portfolio 4/21/2026

    The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.

  5. Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation 4/15/2026

    Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.

  6. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

  7. How To Implement Post-Approval Changes On A Global Level 4/14/2026

    To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

  8. March 2026 — CDMO Opportunities And Threats Report 4/14/2026

    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.

  9. The Business Case For Continuous Manufacturing In Biologics 4/14/2026

    The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

  10. Mastering Biotech's Insourcing/Outsourcing Trade-Offs 4/10/2026

    Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.