Scalable range of single-use bags enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using just the one polyethylene film. The line, called Flexsafe, is based on a multilayer, proprietary polyethylene (PE) film, called S80, and has been developed in close collaboration with resin and film suppliers. A standardized cell growth assay has been used to optimize film formulation, determine the operating ranges for extrusion, welding and gamma-irradiation processes and to establish specifications and process controls. Sartorius Stedim Biotech
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