Cell and Gene Regulatory

1. Overcoming Regulatory Hurdles In AAV Production 12/16/2025

   Demonstrating residual reagent clearance is a critical regulatory requirement in AAV manufacturing. Explore how specialized assays and strategic partnerships streamline compliance.

2. 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.

3. Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D. 12/12/2025

   On this week's episode of the Business of Biotech, Bruce Culleton, M.D., CEO at ProKidney, talks about moving from academic research to industry and the role a key mentor played in his career path.

4. Product Carbon Footprints: The Next Frontier In Sustainable Innovation 12/12/2025

   Product Carbon Footprints reveal true lifecycle emissions, enabling collaboration, innovation, and informed decisions. Learn why moving from estimates to evidence is essential for reducing Scope 3 impact.

5. 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.

6. Pave The Way To High Productivity With Continuous Manufacturing For Pharma 12/12/2025

   Continuous manufacturing delivers agility and precision for pharma, combining automation, reduced manual steps, and quality control to meet regulatory and cost pressures while accelerating development.

7. Manufacturing Made More Robust And Customer-Centric 12/11/2025

   Discover how regional manufacturing, risk-aware practices, and agile strategies are reshaping supply chains to deliver resilience, transparency, and sustainability in today’s complex global environment.

8. How GMP And Clinical Rules Shape Upstream Discovery And Development 12/10/2025

   Early collaboration between R&D and manufacturing ensures regulatory readiness and efficiency. Learn how automation and robust panel design enable clinical translation for advanced cell therapy development.

9. FDA's Regenerative Medicine Advanced Therapy (RMAT) Program 12/10/2025

   RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

10. MHRA International Recognition: Fast-Track UK Market Access 12/10/2025

    MHRA’s IRP accelerates UK approvals via trusted regulators, but faster authorization only translates to access when aligned with NICE evidence needs, pricing policy, and coordinated launch strategy.