Insights On Regulatory Compliance

  1. The FDA Modernization Act is Signed Into Law. Now What? 4/22/2024

    Scientists worldwide celebrated the signing of the FDA Modernization Act into law. Gain expert insights into what to anticipate regarding using New Approach Methods (NAMs) in novel IND submissions.

  2. How To Solve The Big Challenges Of Cell And Gene Therapy Manufacturing 7/24/2025

    Cell and gene therapies are revolutionizing medicine, but outdated manufacturing methods are slowing progress. Discover how modernizing CGT production can unlock the full potential of life-changing treatments.

  3. Revolutionizing Aseptic Fill/Finish With Innovation 4/21/2025

    Experience an innovative aseptic fill-finish technology designed for ATMP production in this live demo, which is a cutting-edge solution that ensures optimal efficiency and product quality.

  4. 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.

  5. Ensuring Integrity: A Comprehensive Approach To CCI 1/8/2026

    Deterministic CCI testing ensures compliance in packaging. Learn how advanced methods like Vacuum Decay, HVLD, and Helium Leak Detection deliver results aligned with USP 1207 and global standards.

  6. Navigating Governance For Quality Assurance And IT Compliance 2/6/2026

    Agentic AI can speed decision‑making, but only with strong governance. Learn how private deployments and governed data sources enable safe, compliant use without compromising quality.

  7. Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap 7/23/2025

    As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

  8. Tips For Tracking And Recreating Your Golden Batch 9/18/2025

    Discover how pharmaceutical manufacturers are using digital tools to achieve the “golden batch”—a production run that balances quality, efficiency, and compliance through smarter processes.

  9. Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System Qualification 11/24/2025

    Explore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.

  10. Building An Effective Contamination Control Strategy For Final Sterile Filtration 8/13/2024

    Watch to learn about important considerations for final sterile filtration throughout product development and for performing pre-use post-sterilization integrity testing.