Cell and Gene Regulatory

  1. Gloveless Robotic Isolators Meet Annex 1 For Aseptic Filling 1/9/2026

    Robotic, gloveless isolators redefine aseptic filling by meeting Annex 1 standards. Discover how this approach ensures product integrity through automation for clinical and commercial manufacturing.

  2. Aseptic Filling Inspection Support Service 1/9/2026

    Prepare for GMP audits with confidence through expert guidance and tailored coaching. Explore how this service helps you navigate the regulatory complexities of advanced aseptic filling systems.

  3. Aseptic Process Design And Simulation Under Annex 1 Guidelines 1/9/2026

    Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.

  4. Accelerate GMP Certification With Annex 1-Compliant Aseptic Automation 1/9/2026

    Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.

  5. USP 661.1 Vs 661.2: Key Differences And Compliance 1/9/2026

    USP 661.1 and 661.2 introduce rigorous, risk-based standards for pharmaceutical plastic packaging, emphasizing material characterization, system suitability, and extractables/leachables testing to ensure safety and compliance.

  6. The Editors' Roundtable: A 2025 Retrospective of the Life Sciences Industry 1/8/2026

    We’re sharing this episode on Cell & Gene: The Podcast because Better Biopharma is a sister podcast within the Life Science Connect family. This conversation speaks directly to the challenges and opportunities our Cell & Gene: The Podcast audience is navigating right now.

  7. Flexibility First: A Fill And Finish Collaboration Story 1/7/2026

    Learn how Annex 1 is influencing isolator strategies, why standardization is key to efficiency, and how collaboration can simplify integration for reliable drug product filling.

  8. Select Your Best Downstream Process Intensification Strategy 1/7/2026

    Intensified and connected processing can cut costs and eliminate bottlenecks in mAb manufacturing. Discover how to identify the most efficient chromatography methods and future-proof your operations.

  9. Compliance In Conversation: A Fill And Finish Regulatory Roundtable 1/7/2026

    Explore Annex 1 expectations, PFAS legislation, and contamination control strategies in this expert-led discussion, as well as practical insights on risk mitigation, validation, and inspection readiness.

  10. Global Shifts And Strategic Resilience Will Shape CGT In 2026 1/7/2026

    Dr. Miguel Forte, CEO of Kiji Therapeutics and President of ISCT, and Ali Pashazadeh, Founder of Treehill Partners share why CGT developers are now navigating a landscape defined not only by technological innovation but also by geography, regulatory agility, and investment dynamics.