Contributing Editors
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SUS Interchangeability Assessment And Qualification Best Practices
3/12/2026
Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.
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New MIT Consortium Links Innovation With Real-World Biomanufacturing
3/6/2026
In one area, the Initiative for New Manufacturing is exploring whether microfactories, championed by the EV industry, can help biopharma iterate facility design faster.
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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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.