Outsourced Pharma Editorial

  1. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

    In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

  2. What Reliance, Annex 1, And AI Mean For The Future Of GMP 5/29/2026

    EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

  3. A CMC Playbook For Leadership And Hiring 5/28/2026

    Would you like a shortcut to failure in regulatory CMC? Hire extensively based on what candidates already know. That’s a provocation underlying a number of conversations with senior leaders in regulatory CMC, and it feels especially relevant to outsourcing. With the correct attitude and leadership, learning (yes, on the job) may beat credentials for long-term success.

  4. Why Is Biopharma Left Out Of The U.S. Infrastructure Conversation? 5/26/2026

    Investment manager BlackRock gathered powerful investors to discuss along with government officials the nation’s physical and economic backbone. The Infrastructure Summit clarified the biopharma industry including CDMOs are in a battle for investments and infrastructure. Analysis from Chief Editor Louis Garguilo.

  5. Applying Contamination Control By Design: A Practical Guide For CDMOs 5/26/2026

    This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

  6. BIOSECURE Act And The 8 Supply-Chain Lessons Sponsors Can't Ignore 5/26/2026

    For sponsors rethinking China-exposed supply chains, BIOSECURE is less a warning label than a stress test for redundancy, oversight, data control, and operational resilience.

  7. AI Stuck Upstream? It Still Influences Manufacturing Outsourcing 5/21/2026

    AI may help run and optimize bioreactors at your CDMO. There is pervasive pressure to move manual (and reactive) control to AI-autonomous (predictive systems). You may already select your CDMO partially based on its systematic utilization of AI in its facilities. But at this moment of transition, while the odds are high AI may not fully reside in the manufacturing plant today, it increasingly shapes the decisions determining what and how programs get to that plant.

  8. Rethinking CQV In A Digital, Agile Manufacturing Landscape 5/21/2026

    While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

  9. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

    FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

  10. Kodak's CEO Leans Into Biopharma Manufacturing – "I'm An Operator" 5/18/2026

    Kodak’s Eastman Business Park in Rochester was the focus of a recent editorial. But the man leading Kodak’s comeback, Jim Continenza, Chairman and CEO, is a topic unto himself. He’s as animated as any public-company CEO you’ll encounter. And he knows his audience; in his conversation with Chief Editor Louis Garguilo he says Kodak “has always supplied CDMOs and the industry with important chemicals.” Read his vigorous take on domestic manufacturing and other supply-chain topics.