Cell and Gene Regulatory

1. 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.

2. 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.

3. Accelerating Milestones And Reducing Regulatory Risk 12/10/2025

   Modern adaptive Phase 1 oncology trials speed timelines, refine dosing, and meet FDA standards, replacing outdated 3+3 methods to boost efficiency, safety, and regulatory success.

4. Why Multi-Omic Insights Demand A Multi-Omic Strategy 12/10/2025
5. Gene Therapy & CDx: Smarter Development 12/10/2025

   Gene therapy success depends on optimized vectors, robust trials, biomarker-driven strategies, and coordinated regulatory planning for companion diagnostics and FDA engagement.

6. 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.

7. MES Apps Built For Speed And Seamless Integration 12/9/2025

   Digitize bioprocess workflows to achieve consistent, paper-free execution that deploys up to 66% quicker than traditional MES with a cloud-based, no-code platform built for single-use bioprocessing.

8. Fill And Finish: Your Final Step Is Our First Priority 12/9/2025

   Fill and finish demands precision, compliance, and adaptability. Learn how flexible solutions and expert support can help you overcome complexity, reduce risk, and ensure quality in this final step.

9. Lessons From FDA 483s And Warning Letters: Cleanroom Compliance 12/8/2025

   Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

10. Engineering B Cells With Immusoft's Sean Ainsworth 12/5/2025

    On this week's episode of the Business of Biotech, Sean Ainsworth, CEO and Chairman at Immusoft, talks about transitioning from the research bench to entrepreneurship, his M&A experiences as a biotech founder, and why engineered B cell therapies offer a better, more patient-friendly administration for lysosomal storage diseases currently treated with enzyme replacement therapies.