Biosimilar Regulatory solution center

  1. Three Tips To Put Your Viral Vector On The Path To Regulatory Success 1/15/2026

    Gene therapy regulations are evolving fast, creating uncertainty for developers. Discover three strategies to navigate approval challenges and keep pace with changing expectations.

  2. A Sustainable Future: Phasing Out Animal Testing 1/14/2026

    Discover a practical roadmap for replacing animal tests with advanced molecular methods, as well as how regulatory updates and innovative technologies are shaping a sustainable future.

  3. Enhanced Flow Kit Performance With Leak And PUPSIT Testing 1/13/2026

    Sterile drug filtration demands rigorous integrity testing to prevent contamination. Learn how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.

  4. Automated PUPSIT For Drug Product Applications 1/13/2026

    Automated filtration systems streamline PUPSIT, leak testing, and integrity checks to ensure sterile drug product processing. Learn how these methods improve contamination control and compliance.

  5. 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.

  6. Wetting Recommendations For Successful Filter Integrity Testing 1/12/2026

    Discover best practices for hydrophobic and hydrophilic filters, troubleshoot failures, and optimize wetting in stainless steel and single-use systems to ensure process reliability and product quality.

  7. 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.

  8. 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    Aseptic filling is vital yet often guided by outdated practices.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.

  9. 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    Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards.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.

  10. 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.