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  1. An Integrated, Verified PFS System For Vaccines 2/23/2026

    A pre-verified delivery platform eliminates redundant testing, simplifies regulatory submissions, and optimizes inventory management, allowing teams to focus on drug-specific performance.

  2. Freeze Your Device Design With An Integrated, Verified PFA System 2/23/2026

    Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.

  3. De-Risk Your Combination Product Development 2/23/2026

    Adopting a unified, pre-verified drug delivery system streamlines performance testing and data management, ensuring developers reach critical clinical milestones with greater speed.

  4. 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.

  5. Ultrafiltration/Diafiltration TFF System For Enhanced Oligo Purification 2/22/2026

    Modernize oligonucleotide manufacturing with robust filtration systems built for hazardous environments. Enhance purity and speed across every batch to ensure reliable and scalable production.

  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. Four Common Pitfalls To Avoid In UF/DF Setup And Scale-Up 2/18/2026

    Learn how small UF/DF decisions can create major scale-up challenges, as well as practical ways to improve membrane selection, reduce manual operations, and boost PD–MSAT alignment.

  10. 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.