Guest Columns

1. Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE 2/27/2026

   By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.

2. Green Supply Chains Rarely Start With A Pledge; Target Waste Instead 2/27/2026

   Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.

3. The Real Reason We Haven't Fully Automated Cell Therapy Yet 2/26/2026

   Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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. 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.