Bacterial polysaccharides are utilized in vaccines and inflammatory challenge models to trigger the body’s natural immune system, inducing a robust and broad immune response. The response is harnessed in vaccines to protect against a wide range of infectious and immune mediated diseases.
List Labs has a wealth of experience manufacturing bacterial polysaccharide products for research, vaccine development, and for use in clinical trials. Along with custom client preparations of crude polysaccharide extracts for vaccine development, we expertly produce a highly purified GMP lipopolysaccharide for clinical trials — which has been used by major pharmaceutical companies, universities, and the NIH Clinical Center.
List Labs staff has over 25 years’ experience manufacturing bacterial based novel drug substances and products. List maintains several Drug Master Files with FDA and Health Canada and provides support to clients for IND filings. As required by the State of California, List Labs maintains a current Drug Manufacturing License.
List Labs has manufactured a variety of bacterial toxins and proteins, live biotherapeutics products (LBPs), and polysaccharides for our clients. cGMP manufacturing has included both drug substance and drug products for Phase I and II clinical trials.
List complies with 21 CFR 210, 211, as well as ICH and Regulatory Guidelines, as applicable, for early stage Investigational New Drugs (IND) and Investigational Medicinal Products (IMP).
Learn More about List Labs’ Bacterial Polysaccharide Capabilities
Our proprietary chromatography methods effectively remove traces of proteins and nucleic acids for an ultrapure LPS product.