Guest Columns & From The Editor

31. 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.

32. 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.

33. Injecting Cancer Killers: Intratumoral Therapy For Solid Tumors 3/5/2026

    Intratumoral injection bypasses the tumor’s physical defenses entirely, killing cancer cells and creating a personalized immune response that destroys solid tumors.

34. Proteomics Tools: A Resurrection 3/4/2026

    For decades, the evolution of proteomics has lagged. Now, a resurrection is underway. New tools are dismantling limitations, signifying a maturation of systems biology.

35. Powering AI And Synthetic Biology In Therapy Design 2/27/2026

    AI-driven cell therapies depend on high-quality, well-structured data to accelerate discovery, development, and clinical success.

36. Six Specialized Modalities Testing CDMO Readiness In 2026 2/27/2026

    As biopharma pipelines shift toward more complex therapies, sponsors are finding that CDMO readiness now depends less on general capacity and more on highly specific technical capabilities.

37. 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.

38. 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.

39. 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.

40. 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.