Cell and Gene Regulatory

1. Transforming Patient Access To CGT 4/28/2025

   Chief Commercial Officer Aruna Mor recently delivered a powerful keynote at the Advanced Therapies Congress in London, highlighting the challenges of patient access to advanced therapies.

2. Enabling The Outcome Through Enhancing Patient Accessibility 4/28/2025

   To ensure that the transformative potential of cell and gene therapy reaches every patient in need, we must prioritize equitable access and overcome the remaining barriers to widespread delivery.

3. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

   Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

4. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

   Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

5. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

6. CRI's Response to NIH Cuts with Alicia Zhou, Ph.D. 4/22/2025

   In this episode of the Cell & Gene podcast, Host Erin Harris speaks with Alicia Zhou, Ph.D., CEO of the Cancer Research Institute (CRI), about CRI’s mission to advance cancer immunotherapy and the critical role of federal funding, particularly from the NIH, in supporting basic and translational cancer research.

7. The Future Of GxP Manufacturing With AI 4/21/2025

   Discover how to digitize batch records in just 180 days with Christian Gay Porcel by leveraging AI for automated compliance and scalable validation.

8. Accelerate Development With Excipient GMP Quality Cell Culture Solutions 4/21/2025

   Reduce risk and speed up timelines as you move towards commercialization. Learn about end-to-end services offering Excipient GMP cell culture solutions for streamlined development and regulatory success.

9. Revolutionizing Aseptic Fill-Finish With Innovation 4/21/2025

   Experience an innovative aseptic fill-finish technology designed for ATMP production in this live demo, which is a cutting-edge solution that ensures optimal efficiency and product quality.

10. Mitigate Clinical Risk In Cell Therapy Development With A GMP Compliant Process 4/21/2025

    Help shape the future of medicine by building better, safer cell therapies. See how expertise in scalable, GMP-compliant cell engineering can effectively mitigate clinical development risks.