Manufacturing Capabilities

The facility provides 8,000 total square feet of cGMP-compliant cleanroom biomanufacturing space, a 2,000 square-foot process development lab, and a 2,000 square-foot analytical testing lab, as well as office, meeting, warehouse, and mechanical space. Controlled, classified cleanroom space is segregated into two independent biologic manufacturing areas, located in two separate buildings on the VelocityTX campus.

Scorpius provides cGMP contract manufacturing for therapeutic proteins, vaccines, and vectors produced in both mammalian and microbial systems. Scorpius' biomanufacturing facilities provide world-class capabilities utilizing single-use, disposable technology for cost-effective production. Single-use systems reduce the risk of contamination and/or cross-contamination, allow for quick changeover between batches, and reduce or eliminate the need for cleaning validation studies.

Scorpius utilizes American-manufactured equipment and consumables, such as the Pall Allegro^™ STR single-use family of stirred tank bioreactors that deliver consistent and scalable cell culture and microbial fermentation performance. Current capabilities include 50, 200, 500,  and 1,000L mammalian cell culture bioreactors and 50 and 200L microbial fermentation reactors. Cell harvest capabilities include bioprocess-scale centrifugation, continuous flow centrifugation, kSep 400 as well as microfiltration. Downstream process capabilities include ultrafiltration/diafiltration, column chromatography, sterile filtration, and fill-finish.

Facility Design Features

• Multi-use, multi-product, cGMP-compliant facility designed for the manufacture of preclinical, clinical scale and limited commercial-scale biologics
• Optimal flexibility and versatility while minimizing the potential for contamination and/or cross-contamination of manufactured materials to ensure product safety and quality
• Cleanroom areas – each with dedicated air handling units – provide controlled and monitored contract manufacturing environments utilizing HEPA-filtered air providing air quality classifications from EU Grade D to Grade A
• Cleanroom areas employ separate entry and exit airlocks designed to minimize the potential for contamination and/or cross-contamination of manufactured materials
• Cleanroom class pressurizations are targeted to a pressure differential ≥ 0.05” w.c. at rest for areas of different classification and ≥ 0.025” w.c. at rest for areas of the same classification
• Cleanroom finishes, equipment, and materials were chosen for mobility and ease of cleaning and product changeover while the facility design promotes unidirectional flow of all personnel and materials
• Controlled cleanroom manufacturing areas are compliant with current FDA, EU Annex 1, and PMDA cGMP regulations