Industry Insights

31. Powering Cell Therapies With RNA: A New Code For Engineered Immunity 12/19/2025

    RNA is redefining cell therapy engineering—enabling transient, programmable control of immune and stem cells while simplifying manufacturing, improving safety, and accelerating scalable, virus-free workflows.

32. Why Efficiency In Multi-Modal CGT Manufacturing Is About Execution, Not Just Cost 12/18/2025

    Our recent Cell & Gene Live, Driving Efficiency, Reducing Costs in Multi-Modal CGT Manufacturing, explored how developers and CDMOs are navigating multi-modal manufacturing decisions, balancing cost, capacity, risk, and long-term commercial viability.

33. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

    Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

34. November 2025 — CDMO Opportunities And Threats Report 12/16/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

35. 2025's Top 5 Drug Discovery Highlights And How To Stay Ahead In 2026 12/15/2025

    Drug Discovery Online's 2025 Top 5 most consequential shifts affecting this rapidly evolving field, including NAMs, AI, Individualized Therapies, Innovating China, and Early-stage Funding Volatility.

36. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

37. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

    MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

38. CSL's HEMGENIX Shows Durable Benefit, A New Future For Gene Therapy in Hemophilia B 12/12/2025

    CSL's Dr. Deborah Long and Diego Sacristan highlight HEMGENIX's five-year Phase 3 data as a watershed for hemophilia B gene therapy.

39. Cell 2025, Advanced Therapies USA Taught Me Why Platformization Is No Longer Optional 12/10/2025

    True scalability and global-ready CGT manufacturing depends on platformization that tightly integrates MES, ERP, LIMS, and related systems into a harmonized, leadership-driven digital backbone that treats data as a strategic asset.

40. Overcoming Cell Therapy Design Challenges To Treat AML And Other Life-Threatening Diseases 12/9/2025

    CERo CEO Chris Ehrlich discusses how a focus on safety, robust manufacturing, and key early indicators is rewriting the playbook for future personalized medicine trials.