Featured Editorial

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. A Biotech Business Model That's Investor-Friendly 3/2/2026

   For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.