Expert Insights On Fill/Finish

1. Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring 7/22/2026

   Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

2. Addressing The Particulate Challenge In Cell Therapy Products 7/15/2026

   Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.

3. An Open-Source Modeling Tool For Suspended Continuous Lyophilization 7/7/2026

   Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.

4. Why Dilution Gets Tricky: The Role Of Measurement Variability 5/5/2026

   Dilution's effects on downstream processes and final formulation is often understated. A statistical framework can quantify measurement uncertainty's impacts.

5. Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign 3/27/2026

   The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

6. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

   A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

7. 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.

8. 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.

9. 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.

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.