Regulatory Guidance And Enabling Compliance

  1. Implementing Rapid Microbial Identification In Biotherapy Manufacutring 5/27/2025

    Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.

  2. Microbial Identification Via DNA-Seq 6/9/2025

    Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.

  3. CMC Comparability: Transitioning to Commercial Manufacturing with Dr. Nicole Verdun 1/30/2024

    In this segment, Dr. Nicole Verdun shares some of the challenges demonstrating CMC comparability during late-stage product development (i.e., pivotal or Phase 3 clinical trial) that occur while transitioning to commercial manufacturing.

  4. 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.

  5. Rapid Micro Methods In QC Micro Testing: A NIBRT Perspective 5/29/2025

    Learn about some of the advanced Rapid Micro Method systems that are being adopted by biopharma companies worldwide, and how they are changing the face of QC Microbiological testing.

  6. Maximize Quality Assurance Through Rapid Sterility Testing 9/10/2024

    This webinar explores mitigating the risk of product loss, and production delays, as well as the critical role rapid sterility testing plays in ensuring the quality and safety of cell therapy products.

  7. 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.

  8. 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.

  9. Challenge #1: The Changing Regulatory Landscape 1/30/2023

    By 2030, 60 CGTs are expected to reach regulatory approval. One of the biopharmaceutical industry's most closely watched regulatory developments is the FDA’s reauthorization of the Prescription Drug User Fee Act (PDUFA) or PDUFA VII, as it provides resources for the FDA and CBER to have the capacity to provide feedback on development and review submitted applications, among other critical activities. During our Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio break down how PDUFA VII, Fiscal Year 2023 Omnibus Appropriations Bill, and more will impact the cell and gene therapy field in the next few years.

  10. Interview With Nico Chow And Sandi True, Field Applications Specialists 11/6/2025

    Hear Nico Chow and Sandi True, Field Applications Specialists, discuss working with customers to help them evaluate and implement Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.