Scorpius BioManufacturing
Scorpius BioManufacturing is a U.S. biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Located in San Antonio, Texas, it specializes in working with emerging biotechs, academic researchers, and U.S. Government institutions. The company emphasizes quality, speed, flexibility, and responsiveness, with capabilities including mammalian and microbial biomanufacturing, analytical services, and a commitment to American-made equipment and consumables. It aims to be a leading CDMO for emerging biotech innovators, supporting the development of safe, high-quality therapies through lifelong partnerships.
Industries
Nr. of Employees
medium (51-250)
Scorpius BioManufacturing
San Antonio, Texas, United States, North America
Products
Biomanufacturing Services
Provides biomanufacturing services from pre-clinical evaluation to commercial manufacturing, integrating analytical methods development, process development, cGMP manufacturing, product characterization, and QC release testing.
Formulation Development
Offers formulation development services for biopharmaceuticals, including therapeutic proteins, enzymes, immunotoxins, monoclonal antibodies, protein-based vaccines, and cell-based therapies.
Analytical Testing
Develops and validates analytical test methods to characterize biologics, including cell therapy products, protein therapeutics, and vaccines, ensuring product quality and consistency.
Clinical-Scale Facility
Operates a clinical-scale biomanufacturing facility with 2,000 sq. ft. of process and analytical development space and 8,600 sq. ft. of cGMP-compliant cleanroom manufacturing space.
Biomanufacturing Services
Provides biomanufacturing services from pre-clinical evaluation to commercial manufacturing, integrating analytical methods development, process development, cGMP manufacturing, product characterization, and QC release testing.
Formulation Development
Offers formulation development services for biopharmaceuticals, including therapeutic proteins, enzymes, immunotoxins, monoclonal antibodies, protein-based vaccines, and cell-based therapies.
Analytical Testing
Develops and validates analytical test methods to characterize biologics, including cell therapy products, protein therapeutics, and vaccines, ensuring product quality and consistency.
Clinical-Scale Facility
Operates a clinical-scale biomanufacturing facility with 2,000 sq. ft. of process and analytical development space and 8,600 sq. ft. of cGMP-compliant cleanroom manufacturing space.
Services
Clinical and commercial cGMP biomanufacturing
End-to-end biologics manufacturing services including upstream, downstream, formulation, and aseptic fill–finish in cGMP cleanrooms for mammalian, microbial, and cell therapy products.
Upstream and downstream process development
Process development for mammalian and microbial platforms including scale-down modeling, optimization of culture and fermentation conditions, and downstream purification/refolding.
Integrated bioanalytical and GLP-compliant testing
Analytical testing and bioanalysis covering preclinical and clinical phases, GLP-compliant sample analysis, and CMC analytical support for regulatory filings.
Bioassay development and validation
Design, optimization, and regulatory-aligned validation of cell-based assays, immunoassays, and molecular assays (qPCR), including multiplexed and automated formats.
Analytical methods development and QC testing
Method development, qualification, and validation for CMC and characterization techniques (HPLC, SPR, microscopy) and stability testing programs.
Tech transfer consulting and execution support
Advisory and hands-on support to execute sponsor-to-manufacturer tech transfers and reduce manufacturing start-up risks.
Clinical and commercial cGMP biomanufacturing
End-to-end biologics manufacturing services including upstream, downstream, formulation, and aseptic fill–finish in cGMP cleanrooms for mammalian, microbial, and cell therapy products.
Upstream and downstream process development
Process development for mammalian and microbial platforms including scale-down modeling, optimization of culture and fermentation conditions, and downstream purification/refolding.
Integrated bioanalytical and GLP-compliant testing
Analytical testing and bioanalysis covering preclinical and clinical phases, GLP-compliant sample analysis, and CMC analytical support for regulatory filings.
Bioassay development and validation
Design, optimization, and regulatory-aligned validation of cell-based assays, immunoassays, and molecular assays (qPCR), including multiplexed and automated formats.
Analytical methods development and QC testing
Method development, qualification, and validation for CMC and characterization techniques (HPLC, SPR, microscopy) and stability testing programs.
Tech transfer consulting and execution support
Advisory and hands-on support to execute sponsor-to-manufacturer tech transfers and reduce manufacturing start-up risks.
Expertise Areas
- Clinical biomanufacturing
- Mammalian cell culture and cell therapy manufacturing
- Microbial fermentation development
- Upstream and downstream process development
Key Technologies
- Single-use bioreactors
- Stainless steel bioreactors
- Hybrid single-use/stainless production platforms
- Miniaturized/scale-down bioreactor systems