Cell and Gene Regulatory

  1. LabAlert Real-Time Monitoring And Notification System 8/5/2025

    The LabAlert™ wireless laboratory monitoring system is designed to provide secure, real-time oversight of critical lab equipment and environments. This cloud-based platform enables centralized monitoring of temperature, humidity, and CO₂ levels across single or multiple facilities, with customizable alerts delivered via web or mobile app. The system supports FDA 21 CFR Part 11 compliance and eliminates manual data logging with secure, centralized recordkeeping. Easy to install and scalable, LabAlert also includes tools for preventative maintenance tracking and cost management.

  2. Accelerating NAMs For A Human-Based Future In CGT Development 8/1/2025

    The Complement-ARIE Consortium, led by FNIH’s Stacey Adam, Ph.D., is advancing the development, validation, and regulatory adoption of human-based new approach methodologies (NAMs) to transform preclinical testing and accelerate cell and gene therapy development.

  3. Life-Changing Therapies Without A Lifetime Of Development 7/31/2025

    Learn about this integrated suite of services that spans global CRO capabilities, central laboratory services, and IVD & CDx regulatory development consulting.

  4. Rethinking Partnerships In Cell & Gene Therapy 7/30/2025

    Discover how a unique partnership model helps cell and gene therapy developers accelerate progress, reduce risk, and bring transformative therapies to market faster.

  5. Comply With The New NIH Transparency Rules For r/sNA Molecule Research 7/30/2025

    Review new transparency requirements for NIH-funded institutions engaged in research involving r/sNA molecules and regulations for Institutional Biosafety Committees (IBCs).

  6. Risk Assessment Services Align With FDA Guidance For Gene-Edited Human Gene Therapy Products 7/29/2025

    Navigate the FDA's gene therapy guidelines with advanced risk assessment strategies. Optimize gene editing and ensure regulatory alignment for safer, more effective therapies.

  7. Strategies For Optimizing iPSC Cryopreservation, Storage, And Post-Thaw Quality 7/29/2025

    Developing iPSC therapies demands meticulous cryopreservation, smart automation, and risk-based post-thaw quality control to bridge lab development with cGMP manufacturing. The sensitivity of iPSCs requires tailored protocols and a deep understanding of cell behavior under scaled conditions, ensuring consistent, viable products.

  8. FDA Priority Voucher Program Submissions Window Opens On New Website 7/29/2025

    The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.

  9. 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution 7/29/2025

    Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.

  10. Gene Therapy In-Use And Device Compatibility Studies 7/28/2025

    Discover an essential aspect of development that ensures gene therapy products remain safe, stable, and effective throughout preparation and administration by simulating real-world clinical conditions.