Featured Editorial

  1. The Hidden Engineering Behind Successful Upstream Bioprocessing 2/25/2026

    In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.

  2. A Practical Look At Modern Downstream Processing For Biologics 2/25/2026

    Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.

  3. From Biology Grad To Manufacturing Guru 2/24/2026

    Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is her advice for manufacturing outsourcing, and careers.

  4. 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.

  5. 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.

  6. 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.

  7. A Novel In Vitro Glycosylation Approach For Difficult PTMs 2/19/2026

    Post-translational modifications of membrane proteins have been historically challenging. Research shows how an in vitro approach brings stability and predictability.

  8. Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference 2/19/2026

    Risk and fitness for use of interchangeable single-use parts were key themes at the conference. The event exposed communication gaps between suppliers and end-users.

  9. Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing 2/18/2026

    Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.

  10. 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.