Regulatory Guidance And Enabling Compliance

  1. Validation Of A qPCR Assay For Host Cell DNA Quantitation 6/9/2025

    Here, we share the development and validation of a new, highly sensitive and accurate integrated solution for detection and quantitation of host cell DNA to help meet regulatory requirements.

  2. Innovative Contamination Control: Enabling Integrity And Efficiency 10/15/2024

    An integrated approach can enhance contamination control, boost process efficiency, and ensure the production of high-quality cell therapy products.

  3. 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.

  4. 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.

  5. Key Considerations For Rapid Microbial Methods For Mycoplasma Detection 5/29/2025

    Learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.

  6. 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.

  7. Collaborating with the FDA: Dr. Peter Marks and Dr. Nicole Verdun Share Advice For Small And Emerging Biotechs 1/30/2024

    In this segment, Dr. Peter Marks and Dr. Nicole Verdun share their advice and best practices for small and emerging biotechs when working with the FDA.

  8. Advancing Vaccine Development With Novel Chromatography Solutions & Quality Testing 6/24/2025

    Learn more on novel chromatography solutions that can help improve the downstream processes of different vaccine types such as mRNA, recombinant proteins, and Virus-Like Particles (VLPs).

  9. 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.

  10. Understanding AI And Machine Learning's Impact On CGT with Dr. Peter Marks and Dr. Nicole Verdun 1/30/2024

    During this segment, Dr. Peter Marks and Dr. Nicole Verdun share their take on how AI and machine learning will impact FDA regulation in 2024.