Biosimilar Manufacturing solution center

  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. 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.

  3. 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.

  4. 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.

  5. 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.

  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. mRNA Manufacturing With Fed-Batch In Vitro Transcription 2/13/2026

    A milliliter-scale approach to IVT optimization reveals how controlled feeding, precise pH management, and real-time monitoring can boost mRNA yield and streamline scale-up to larger bioreactor volumes.

  8. A Comprehensive Solution For Adventitious Agent Testing 2/13/2026

    Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.

  9. 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."

  10. This Industrial Fungus Has Protein Expression Promise For Pharma 2/12/2026

    Trichoderma reesei is well characterized for industrial uses. A Finnish research group is exploring it for pharmaceutical protein expression.