Biosimilar Regulatory solution center

  1. Building Enterprise Resilience From QRM Signals 1/16/2026
  2. Single-Use Standards Are Maturing, But The Process Remains King 1/13/2026

    The food industry inspired single-use in biopharma, but the regulatory landscape is far more complex. If you're worried about compliance, this discussion can help.

  3. Why Choose Robotic Processing For Small Batch Aseptic Filling 1/9/2026

    Reducing human intervention in aseptic filling is critical for safety and cost efficiency. Learn why automation is essential for small-batch applications and how it’s transforming sterile drug manufacturing.

  4. Key Topics And Trends In Aseptic Filling 1/9/2026

    Aseptic filling is vital yet often guided by outdated practices. Discover expert insights on modern technologies, evolving regulations, and data-driven strategies to improve compliance and reduce risk in this critical manufacturing step.

  5. Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process 1/9/2026

    Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.

  6. 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.

  7. 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.

  8. New USP Research Shows MAM As Alternative To Conventional Methods 1/9/2026

    Results show the multi-attribute method provided superior specificity and detected molecular modifications far better than the status quo.

  9. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

  10. Product Carbon Footprints: The Next Frontier In Sustainable Innovation 12/12/2025

    Product Carbon Footprints reveal true lifecycle emissions, enabling collaboration, innovation, and informed decisions. Learn why moving from estimates to evidence is essential for reducing Scope 3 impact.