Regulatory Guidance And Enabling Compliance

  1. 2024 Regulatory Outlook With Dr. Peter Marks And Dr. Nicole Verdun | Audience Q&A 1/30/2024

    Experts on the Cell & Gene Live event, 2024 Regulatory Outlook, answer questions about topics including pediatric development in rare diseases, diversity planning for ultra-rare disease, anticipated approvals by 2025, and more.

  2. A Successful Journey To Cell Therapy Manufacturing 5/29/2025

    Learn about the three main areas to consider when you're preparing to commercialize a cell therapy, including starting/raw material, the controlled manufacturing process, as well as testing safety and quality.

  3. 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.

  4. 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.

  5. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

  6. A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems 11/10/2025

    In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.

  7. 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.

  8. Interview With Pharma Analytics Field Application Specialist - Sandi True 11/6/2025

    Hear Sandi True, a Field Applications Specialist discuss helping customers navigate challenges often encountered when evaluating and implementing Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.

  9. ResDNASEQ Workflow Solution 5/22/2025

    Explore the Applied Biosystems resDNASEQ workflow solutions. Starting with the sample preparation kit, to purification, quantitating residual host-cell DNA, and analyzing resDNASEQ assays.

  10. 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.