This outlines biopharmaceutical manufacturers’ requirements for an improved harvest clarification solution that will operate with feedstream cell densities up to 150 million cells/mL in a single-use production scenario. The URS contains requirement details covering functional requirements (e.g. operating temperature and temperature change), qualification requirements (e.g. microbial control), quality requirements (e.g. biocompatibility) and supply chain requirements (e.g. lead times).It will give equipment vendors an understanding of what biomanufacturers foresee in this space and help them find solutions that are compact, relatively mobile and can manage these ultra-high cell density solutions.

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