Cell and Gene Regulatory

  1. Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs 4/15/2025

    The ability to produce billions of NK cells in a single production run represents a transformative shift in the economics and logistics of cell therapy.

  2. Navigating Global Regulatory Landscapes In An Evolving Biopharma Industry 4/15/2025

    Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management, supplier collaboration, and future market trends.

  3. Control Strategies And Method Development For Nitrosamines In APIs And Drug Products 4/15/2025

    Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.

  4. From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials 4/14/2025

    Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

  5. Clinical Trial Regulations 4/11/2025

    This essential guide walks through mastering the complex landscape of clinical trial regulations, providing a clear, practical breakdown of regulatory timelines, legal obligations, and more.

  6. How Does RWE Impact Clinical Trials? 4/10/2025

    Explore the growing impact of Real-World Evidence (RWE) on clinical trials, particularly in rare disease research.

  7. Conflict Of Interest: Implications For Clinical Research Sites 4/10/2025

    Amid scrutiny of the financial conflicts of interest in biomedical research, new federal rules aim to improve transparency and preserve the integrity of publicly funded research.

  8. Is Your Clinical Research Site GCP-Ready? 4/9/2025

    Explore a comprehensive overview of Good Clinical Practice (GCP) guidelines. By fostering a culture of continuous improvement through internal audits, clinical research sites can identify non-compliance issues and enhance their research practices.

  9. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

    In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

  10. 2025 CGT Regulatory Outlook | Audience Q&A 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) answer questions from the audience. They covered key regulatory topics, including the FDA’s process for finalizing draft guidances, the status of INTERACT meetings, and the use of the term “critical component” in manufacturing regulations.