Contributing Editors

  1. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

  2. Trends In FDA FY 2025 Warning Letters 3/13/2026

    The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.