Cell and Gene Regulatory

  1. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

  2. Comprehensive, Integrated BioServices 5/2/2025

    Discover more about optimized storage, packing, labeling, and global distribution, seamlessly integrated for your supply chain. Simplify complexity and enhance the reliability of your supply chain.

  3. 8 Best Practices For Immunogenicity Assay And Companion Diagnostic Development In AAV Gene Therapy 5/2/2025

    Read more to understand why the partnership between gene therapy companies and diagnostic developers is crucial for advancing the field of gene therapy.

  4. Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy 5/2/2025

    In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).

  5. Gene Therapy Assays: Regulatory Compliance With Unified Immunogenicity 5/2/2025

    Explore the complexities of immunogenicity assessment in gene therapy development that focuses on regulatory frameworks in the US and EU, and gain insight into the best practices for global compliance.

  6. Key Strategies For Future-Proofing Gene Therapy Assay Validation 5/2/2025

    Rigorous validation of immunogenicity assays is crucial for ensuring safety and efficacy, especially in the evolving regulatory landscape. Discover the importance of understanding regulatory standards.

  7. Do We Really Understand Plasmid Quality's Effects On mRNA Production? 5/1/2025

    Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.

  8. Future-Proofing The Material Transfer Process In Your Facility 5/1/2025

    Minimize contamination risks in Grade A/ISO 5 areas. Discover how integrating automated bio-decontamination with manual methods enhances your cell and gene therapy material transfer program.

  9. Transforming Patient Access To CGT 4/28/2025

    Chief Commercial Officer Aruna Mor recently delivered a powerful keynote at the Advanced Therapies Congress in London, highlighting the challenges of patient access to advanced therapies.

  10. Enabling The Outcome Through Enhancing Patient Accessibility 4/28/2025

    To ensure that the transformative potential of cell and gene therapy reaches every patient in need, we must prioritize equitable access and overcome the remaining barriers to widespread delivery.