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Manufacturing

Manufacturing Capabilities

Scorpion’s new pre-clinical and clinical scale biologics manufacturing facility is currently under construction and is scheduled to open in April 2022 in the heart of San Antonio, at the VelocityTX Innovation Center.

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 manufacturing areas, located in two separate buildings on the VelocityTX campus.

Scorpion provides cGMP manufacturing for cell therapy products including cells and exosome/secretome products as well as therapeutic proteins, vaccines, and vectors produced in both mammalian and microbial systems. Scorpion’s 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.

Scorpion 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, 1000 and 2000L mammalian cell culture bioreactors and 50L microbial fermentation reactor. 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.

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Scorpion has implemented easily scalable manufacturing unit operations solutions for both upstream and downstream processes, making process development and subsequent production more streamlined. The majority of our product contact surfaces are single-use, disposable components, and therefore the demands on maintenance, cleaning and cleaning validation are minimal.

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 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