Contributing Editors

1. Process Engineering's Key Role In Sterile Injectable Facility Design 2/24/2026

   Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

2. Rethinking Product Development Through Lipid-Based Formulations 2/24/2026

   Optimization of lipid-based drug formulation, when developed with the correct technology, can lead to major product performance enhancements that benefits patients.

3. What To Know About — And How To Apply For — FDA's PreCheck Pilot 2/23/2026

   FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.

4. MES Is Still In The CD ROM Era But The Data Architecture Has Moved On 2/20/2026

   Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

5. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

   Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

6. A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset 2/18/2026

   Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.

7. The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality 2/13/2026

   The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."

8. January 2026 — CDMO Opportunities And Threats Report 2/12/2026

   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. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

   International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

10. The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing 1/21/2026

    The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.