Industry Insights

1. In Vivo LNP-Engineered Cytokine-Armored CAR Cells For Solid Tumors 12/23/2025

   By injecting lipid-based nanoparticles encapsulating mRNA and encoding the CAR directly into the bloodstream, developers can effectively reprogram the patient's own immune cells in situ.

2. CGT Industrialization Starts With CDMO Alignment 12/19/2025

   Fragmented processes are stalling progress. By aligning CDMOs through transparency and standards, developers can move past the COGS obsession and stabilize the supply chain.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.