Cell and Gene Regulatory

  1. Modernizing Your Way to Success In Cell And Gene Therapy Manufacturing 7/24/2025

    Cell and gene therapy has evolved from a niche concept to a booming sector in just five years, with over 1,300 companies and growing momentum in innovation, investment, and regulatory approvals.

  2. Ensuring AI Compliance In Life Sciences: 5 Critical Requirements 7/24/2025

    Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

  3. The Path To Faster, Easier, Digital Logs Is Made With MX 7/24/2025

    Struggling with missing logbooks or tedious cleanroom reviews? Discover how electronic logbooks streamline compliance, boost efficiency, and unlock insights to transform operations.

  4. Overcoming Gene Therapy Cost Roadblocks On The Path To Patients 7/23/2025

    Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.

  5. Viral Gene Therapy: Reducing Costs To Improve Patient Access 7/23/2025

    Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.

  6. Contamination Control Strategies For Gene Therapy Manufacturing 7/23/2025

    Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

  7. All Of Us Need To Be Rooting For The FDA 7/23/2025

    In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.

  8. Lab Equipment Monitoring For The Modern Lab 7/22/2025

    Ensuring the integrity of results and maintaining regulatory compliance are paramount concerns for any lab today, especially with increasingly complex laboratory processes. Cloud-based device management offers several advantages for laboratory equipment monitoring.

  9. Navigating The Regulatory Landscape Of mRNA-Based Therapeutics 7/21/2025

    Explore the evolving regulatory landscape of mRNA therapeutics in the EU and US, as well as learn key distinctions and strategic opportunities to optimize your mRNA drug development pipeline.

  10. Tales From The Trenches: Developing Potency Assays Outside Big Pharma 7/18/2025

    Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.