Outsourced Pharma Editorial

  1. A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight 5/18/2026

    A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.

  2. Why Contamination Control By Design Should Matter To Your CDMO 5/18/2026

    EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.

  3. Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not 5/14/2026

    Tokyo Institute of Technology. London Business School. ETH Zürich. What do these institutions – and a biotech based in Mulhouse, France – have in common? Matthieu de Kalbermatten, CEO of CellProthera. His international experience adds up to this: Build an internal quality (cGMP) organization; become the master of the processes you create for your therapy, before moving to external help; then select your CDMO carefully – maybe just prior to Phase III.

  4. Closing The MES Value Gap: Why Technology Isn't The Problem 5/14/2026

    Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.

  5. Why Isolators Do Not Automatically Ensure Annex 1 Compliance 5/12/2026

    Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.

  6. Can A Biotech Create A CDMO Market? 5/11/2026

    Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.

  7. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

    Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

  8. CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO? 5/8/2026

    Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.

  9. April 2026 — CDMO Opportunities And Threats Report 5/8/2026

    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.

  10. Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem 5/6/2026

    As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.