INSIGHTS ON CELL & GENE REGULATORY ISSUES
-
![Mirus Bio - Reg Hurdles webinar]( "Overcoming Regulatory Hurdles In AAV Production")
Overcoming Regulatory Hurdles In AAV ProductionDemonstrating residual reagent clearance is a critical regulatory requirement in AAV manufacturing. Explore how specialized assays and strategic partnerships streamline compliance.
-
![Emails with warning signs-GettyImages-2169663027]( "What 2025 FDA Warning Letters Tell Us About GMP Compliance")
What 2025 FDA Warning Letters Tell Us About GMP ComplianceThis 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.
-
![Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D.]( "Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D.")
Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D.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.
-
![GettyImages-2203958101-sustainability-green-grass-floating-bubbles]( "Product Carbon Footprints: The Next Frontier In Sustainable Innovation")
Product Carbon Footprints: The Next Frontier In Sustainable InnovationProduct 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.
-
![European flags-GettyImages-139491451]( "Unpacking The EU's Mutual Recognition Agreements For Pharma")
Unpacking The EU's Mutual Recognition Agreements For PharmaMRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
-
![GettyImages-1441662797-laboratory-scientists-equipment]( "Pave The Way To High Productivity With Continuous Manufacturing For Pharma")
Pave The Way To High Productivity With Continuous Manufacturing For PharmaContinuous manufacturing delivers agility and precision for pharma, combining automation, reduced manual steps, and quality control to meet regulatory and cost pressures while accelerating development.
-
![Biopharma Supply Reimagined: Manufacturing Made More Robust And Customer-Centric]( "Manufacturing Made More Robust And Customer-Centric")
Manufacturing Made More Robust And Customer-CentricDiscover 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.
-
![How GMP-clinical requirements can influence upstream discovery and development work]( "How GMP And Clinical Rules Shape Upstream Discovery And Development")
How GMP And Clinical Rules Shape Upstream Discovery And DevelopmentEarly 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.
-
![GettyImages-547131922 research, regulatory, lab]( "FDA's Regenerative Medicine Advanced Therapy (RMAT) Program")
FDA's Regenerative Medicine Advanced Therapy (RMAT) ProgramRMAT 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.
-
![GettyImages-2163506576-computer-ai-compliance-regulatory]( "MHRA International Recognition: Fast-Track UK Market Access")
MHRA International Recognition: Fast-Track UK Market AccessMHRA’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.
