SA25 And Microcell™ Workcells Chart New Territory In Aseptic Filling

Achieving GMP certification under the latest EU Annex 1 guidelines is a critical milestone for CDMOs and biotechs aiming to deliver breakthrough therapies quickly. Updated standards emphasize contamination control strategies, robotics, and automation to minimize human intervention and ensure sterility. Robotic gloveless isolators and aseptic filling workcells, such as SA25 and Microcell™, enable faster tech transfer, reduce contamination risks, and support small- to mid-scale production for early-phase clinical batches. Real-world examples show European CDMOs achieving Annex 1 certification in as little as 14–17 months by leveraging these advanced workflows. For companies racing against time-to-market pressures, adopting flexible, Annex 1-aligned solutions can accelerate scale-up without compromising GMP compliance.

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