Cell and Gene Regulatory

  1. Good Distribution Practice Is Evolving — Here's How 5/15/2025

    Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

  2. Unlocking The Potential Of iPSC Therapies In Regenerative Medicine 5/15/2025

    Cell & Gene Chief Editor Erin Harris hosted this Cell & Gene Live featuring Julie G. Allickson, Ph.D., Chief Technology Officer at Mayo Clinic's Center for Regenerative Biotherapeutics, and Erin Kimbrel, Ph.D., President & Head at Astellas Institute for Regenerative Medicine, as they explored the rapidly evolving landscape of induced pluripotent stem cell (iPSC)-based therapies.

  3. Infectious Diseases - Global Clinical Trial Landscape (2025) 5/14/2025

    The global infectious disease clinical trial landscape has rapidly expanded between 2020 and 2024, driven by the urgency of emerging threats, technological innovation, and evolving regulatory frameworks.

  4. Complexing RNPs: Have You Established Your Clinical Acceptance Criteria? 5/13/2025

    When using CRISPR-Cas proteins for gene editing, it’s critical to ensure consistency and quality at each stage of the manufacturing process. The FDA recommends establishing well-defined acceptance criteria for the RNP formation step.

  5. Replacement Of Traditional Adventitious Virus Testing 5/13/2025

    Explore how molecular-based technologies, including PCR and Next Generation Sequencing, are transforming viral safety testing by offering broader, more effective alternatives to traditional animal-based methods like in vivo assays.

  6. Digital PCR System And 21 CFR Part 11 Regulations 5/13/2025

    Laboratories are increasingly adopting electronic records and signatures to enhance data management. Learn how this digital shift demands compliance with FDA regulations, such as 21 CFR Part 11, to ensure secure, traceable systems.

  7. Direct Quantification Of Residual Host Cell DNA 5/13/2025

    Residual host cell DNA monitoring is vital in biologics manufacturing. Learn how digital PCR offers unmatched sensitivity and precision to ensure compliance with strict safety standards set by global regulatory agencies.

  8. High-Quality Detection Of Mycoplasma Contamination 5/13/2025

    Ensure biopharmaceutical safety with a validated RT-dPCR workflow for mycoplasma detection. Learn how Mycoplasma Standard CFU Kits support compliance and robust contamination testing across diverse sample types.

  9. 3 Strategies For A Successful Journey Toward Cell And Gene Therapy Commercialization 5/13/2025

    CTMC's Amy Hay provides 3 recommendations for teams developing cell and gene therapies, from clinical research through commercialization.

  10. 21st Century Manufacturing Of Injectable Pharmaceuticals 5/12/2025

    Discover how rising competition, niche patient populations, and evolving therapies are reshaping sterile injectable drug development with cutting-edge technologies.