Biologics are a category of medical products derived from living organism or their cells. Biologics are applied to gene therapy, antibody infusions and other regenerative medicine applications. Southwest Research Institute (SwRI) is an independent, non-profit company that offers biologics manufacturing services in FDA-inspected Pharmaceutical Development laboratories. We provide contract research, development and production to support biologics drug development for start-ups, universities, biotech, biopharma and government clients.
To learn more about biologics manufacturing, please contact Jian Ling or call +1 210 522 3953.
Large-Molecule Drug Development for Cell & Gene Therapy Research
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SwRI’s biologics manufacturing laboratory features instruments to analyze cell cultures.
SwRI provides independent laboratories and expert staff to help clients conduct cell and gene therapy research, testing and development. Biologics are creating new opportunities to treat cancer and other diseases with large-molecule drug development.
CGMP Biomanufacturing for Large-Molecule Drugs
SwRI’s CGMP Manufacturing services support large- and small-molecule drug development. Our CGMP biomanufacturing services include upstream process development, downstream process development, formulation development, analytical development, quality control and scale-up manufacturing services. We offer several CGMP biomanufacturing solutions to grow living cells or tissues in controlled environments.
Bioreactors for Cell Culture
We have developed a novel 3D-printed, single-use and scalable bioreactor that is suitable for various applications for biologics manufacturing.
Tissue Engineering & Regenerative Medicine
We offer tissue engineering expertise in biomaterials, materials characterization, biological encapsulation and medical device design and prototyping.
- Stem Cell Research
- Tissue Engineering Scaffolding
- Organ Preservation
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3D-printed Single-use Bioreactor
SwRI's novel bioreactor propagates cells for large-scale drugs used in gene therapy and other biologics applications.
Regulatory Support
Our team helps with documentation for regulatory submissions. SwRI facilities are inspected regularly to maintain high standards and we maintain rigorous testing protocols to ensure product quality and safety.
- Analytical & Regulated Projects
- Clinical Trial Supply Services
- CMC Chemistry Manufacturing Control Services
Analytical Services
Our facilities are equipped with mass spectroscopy, HPLC, ELISA, PCR and other instruments and laboratory services.