Cell and Gene Regulatory

  1. Innovative Strategies For Residual DNA And Viral Titre Quantitation 5/22/2025

    Discover how digital PCR improves the accuracy of residual host cell DNA and viral titre quantification in biotherapeutic manufacturing to enhance product quality, safety, and regulatory compliance.

  2. Responding To Fill-Finish And Automation Scale-Up Challenges 5/21/2025

    Behind every life-saving cell therapy is a complex manufacturing journey. Examine the critical role of automation in overcoming production challenges and ensuring quality.

  3. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

  4. Navigating Regulatory Shifts: EU GMP Annex 1 And USP 382 5/20/2025

    Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.

  5. Mastering The Complexities Of Gene Therapy Document Writing 5/20/2025

    Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.

  6. Master The 2-Point Calibration Process To Maintain Data Integrity 5/19/2025

    Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.

  7. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

  8. Balancing Science With Intellectual Property 5/16/2025

    Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.

  9. 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.

  10. 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.