Biosimilar Manufacturing solution center

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    Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards.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

  2. 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.

  3. What Is Aseptic Processing? 1/9/2026

    Aseptic processing sterilizes products and packaging separately, then combines them in a sterile environment. See how this method ensures safety, extends shelf life, and protects medicines from contamination.

  4. Solve ATMP Aseptic Filling Challenges With Gloveless Isolators 1/9/2026

    Aseptic filling for ATMPs demands precision and sterility. Robotic gloveless isolators minimize contamination risk through automation and real-time monitoring, ensuring compliance for personalized therapies.

  5. 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.

  6. 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.

  7. Metrics, Not Audits, Should Lead Vendor Accountability 1/9/2026

    Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.

  8. Ask The Pros — The Latest In Upstream HCP Mitigation 1/5/2026

    We asked leading experts how upstream interventions can reshape HCP control. Here’s what they shared. Answers have been edited for clarity.

  9. 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For 1/5/2026

    2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.

  10. Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry 1/5/2026

    GlycoNex's denosumab biosimilar development experience illustrates how a "just copy it" approach is an insufficient strategy in modern biomanufacturing.