Scorpius has designed ~6,000 sq. ft. of its contract biomanufacturing facility for mammalian cell culture and harvest, downstream purification processes, formulation, and fill-finish operations.
The biologics CMO facility contains nine cGMP-compliant controlled cleanrooms with dedicated air handling units designed for maximal segregation. Each area is designed for maximum flexibility and includes multiple electrical and process gas drops for use with cell culture incubators, bioreactors, cell harvesting systems, and downstream filtration and purification systems, as well as water for injection (WFI) drops as needed.
The controlled areas are designed for unidirectional flow of personnel, raw materials, intermediates, product, and waste. Cleanroom material finishes on walls, floors, and ceilings are selected for ease of cleaning and are suited to cGMP-compliant biomanufacturing. This minimizes the potential for contamination and/or cross-contamination of manufactured products.