Cell and Gene Regulatory

  1. Why Cleanroom Wipe Fabrics Matter 6/16/2025

    Discover the key fabrics used in cleanroom wipes and how they impact performance, as well as explore substrates, manufacturing methods, and essential attributes to help you choose the right wipe.

  2. Effective Contamination Control 6/16/2025

    Discover key strategies for contamination control in cleanrooms, as well as explore contaminant sources, behaviors, and best practices for cleaning and removal to ensure high standards of product and process quality.

  3. The Benefits Of Low Endotoxin Products 6/16/2025

    Minimizing endotoxin contamination is vital in pharmaceutical manufacturing to protect patients from harmful reactions. Learn more about rigorously tested, low-endotoxin products designed for critical cleanroom and sterile applications.

  4. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

    Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

  5. Advancing Gene Delivery: LNPs, Adenovirus, Lentivirus, And More 6/12/2025

    In this Cell & Gene Live event, moderated by Chief Editor Erin Harris, industry leaders came together to explore the expanding gene delivery toolbox, its impact on therapeutic development, and the future of next-generation gene therapies.

  6. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

  7. Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook 6/12/2025

    This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

  8. Navigating Allogeneic Cell Therapy Supply Chain Management 6/11/2025

    In 2024, allogeneic cell therapies gained clinical momentum and regulatory attention, prompting increased collaboration between developers and the FDA to address safety, manufacturing, and access challenges critical to broader adoption and commercialization.

  9. Navigating Data Management Requirements For Sterile Manufacturing 6/11/2025

    Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.

  10. Easy Integration Of A New Manufacturing Platform 6/11/2025

    Easily integrate an innovative platform into your manufacturing process with seamless onboarding, regulatory support, and expert guidance that is designed to help you confidently adopt good manufacturing practices.