Featured Editorial

1. Where Contamination Control Really Breaks Down In Practice 3/13/2026

   Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

2. Trends In FDA FY 2025 Warning Letters 3/13/2026

   The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

3. SUS Interchangeability Assessment And Qualification Best Practices 3/12/2026

   Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.

4. Accelerating Technology Diffusion In Cell And Gene Therapy 3/11/2026

   Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.