Featured Articles

  1. ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials 1/29/2026

    Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.

  2. Building A Scalable Digital Foundation To Support CGT Manufacturing 1/29/2026

    Explore how digital systems strengthen CGT manufacturing by improving traceability and managing batch‑of‑one, as well as essential steps toward scalable, integrated operations.

  3. Navigating GMP Certification In Cell And Gene Therapy Manufacturing 9/9/2025

    CGT regulations are rapidly evolving. With hundreds of therapies in development, scalable automation and smarter systems are essential to meet compliance, reduce complexity, and protect patient lives.

  4. How To Build Flexibility Into Your CGT Manufacturing Process 9/9/2025

    Scaling production demands both flexibility and strict compliance. Discover how innovators can rethink strategies to meet demand without compromising patient safety or regulatory standards.

  5. Integration Challenges Between Manufacturing Systems And Quality Management 9/9/2025

    Disconnected systems are a leading cause of data integrity violations, which account for over 70% of FDA warning letters globally. Learn why integration is essential for compliance and operational success.

  6. Streamlining Compliance With AI-Powered Regulatory Intelligence 9/9/2025

    Life sciences compliance is complex and ever-changing. Discover how modern solutions can streamline processes, reduce friction, and keep your organization ahead of regulatory demands.

  7. Overcoming CGT-Specific GMP Challenges 9/9/2025

    Every batch in Cell and Gene Therapy is a personalized mission—where quality must be flawless, timelines are tight, and variability is constant. Discover why CGT demands a new quality paradigm.

  8. How To Get Products To Patients Faster With A Connected QMS 8/14/2025

    BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

  9. A Digital Solution Embeds Quality Into Cellular Therapeutics Production 8/14/2025

    Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

  10. How Compliance-Driven CDMOs Win Sponsor Contracts 8/6/2025

    Discover how evolving global regulations are reshaping CDMO strategy. and how digital infrastructure helps manufacturers stay audit-ready, build sponsor trust, and turn compliance into an advantage.