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U.S. Biologics CDMO

Flexible U.S. Biomanufacturing Capacity

Scorpius BioManufacturing is a US-based mammalian and microbial biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities.

We provide pre-clinical and clinical scale biologics contract manufacturing services in the heart of San Antonio, Texas. The facility includes 8,600 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.

We're proud to give innovative small-scale, early-stage programs the attention and flexibility other CDMOs don't. 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. 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.

Our Manufacturing Capabilities:

 

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Mammalian Cell Culture Microbial Fermentation Antibody
Production
Vaccine Manufacturing

 

Available U.S. Biologics Capacity


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, and 500 L mammalian cell culture bioreactors and 50 and 200 L 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, and sterile filtration.

Our Biomanufacturing Facility:

 

 

Scorpius 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.

We pride ourselves on providing every program with responsiveness, personal attention, flexibility, ease of communication, and uncompromising quality.

We Designed Our Facilities to Scale Your Program:

  • Multi-use, multi-product, cGMP-compliant facility designed for the manufacture of preclinical, clinical and small-scale commercial 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 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
  • 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