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Manufacturing

Mammalian Cell Culture

Scorpion has designed ~6,000 sq. ft. of its biologics manufacturing facility for mammalian cell culture and harvest, downstream purification processes, formulation, and fill-finish operations.

The 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 manufacturing. This minimizes the potential for contamination and/or cross-contamination of manufactured products.

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Our easily scalable, single-use cell culture components and systems have been implemented as an alternative to cleanable, reusable systems. This approach results in process-specific benefits such as increased manufacturing flexibility, enhanced sterility assurance, elimination of cleaning and cleaning validation, reduced capital investment, faster processing times with increased productivity, and faster changeover to new product manufacture.