Guest Columns

1. 5 QMS Blind Spots You Should Know About 3/6/2026

   Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.

2. 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.

3. 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.

4. 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.

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. 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.

7. 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.

8. 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.

9. 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.

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.