Regulatory Guidance And Enabling Compliance

1. Focal Points for 2024: Dr. Verdun and Dr. Marks Talk Regulatory Challenges for Cell-Based Therapies 1/30/2024

   Dr. Verdun and Dr. Marks provide detailed feedback on the regulatory challenges facing cell therapy and explain the Agency’s most important focal points for 2024, patient accessibility, and more.

2. A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems Validation 6/9/2025

   Learn practical strategies for validating microbial identification systems in cGMP. Understand regulatory guidance and master a complete Computer Systems Validation plan for full compliance.

3. Innovations In Mycoplasma And Sterility Testing For Biopharma 5/22/2025

   In this webinar, our expert speakers will discuss the types of analytical testing that can be effectively employed in the early stages of therapeutic development and subsequently scaled to meet production challenges.

4. Leveraging dPCR r Techniques To Quantitate Lentivirus Particles 5/28/2025

   Discover how digital PCR can streamline lentiviral vector characterization to reduce variability and improve analytical sensitivity. Learn how this approach can help you comply with regulatory guidance.

5. Navigating Global Regulations, Equity Challenges, And The Future Of Patient Access 4/8/2025

   Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) continue the discussion to explore the complexities of expanded access programs (EAPs) in CGT, highlighting global regulatory differences, ethical concerns, and accessibility challenges.

6. Explore The Analytics Knowledge Hub 5/22/2025

   Discover smarter solutions with the new Analytics Knowledge Hub that provides articles, webinars, e-books, and infographics designed to enhance and streamline your bioprocess workflow.

7. Patient Data's Impact On CMC Robustness 1/30/2024

   When CGT products demonstrate dramatic improvements with minimal safety concerns in a Phase 2 study, sponsors may want to modify the protocol mid-study to increase patient enrollment.

8. Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing 1/30/2024

   In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.

9. Key Regulatory Challenges, Innovations, And Opportunities For CGT In 2025 4/8/2025

   Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) detail how the regulatory landscape for cell and gene therapy in 2025 will continue to be shaped by advancements in science and manufacturing and evolving regulatory guidance.

10. An All-In-One Solution For Residual DNA Quantitation 5/22/2025

    Explore an all-in-one solution for residual DNA quantitation with a 3D lab tour with virtual demos, videos, and interactive instrument guides to experience the full workflow.