Bacterial Polysaccharides

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.  Our extensive experience includes custom client preparations of crude polysaccharide extracts for vaccine development to our highly purified GMP lipopolysaccharide for clinical trials, which has been used by major pharmaceutical companies and universities, as well as the NIH Clinical Center.  We have proprietary chromatography methods to effectively remove traces of proteins and nucleic acids for an ultra-pure LPS product, known as HPTTM LPS.  Our experience includes preparations from an extensive list of bacterial organisms including Escherichia coli, Salmonella minnesota, Salmonella typhimurium, Bordetella pertussis, and Clostridium difficile.

Polysaccharide Production Services

List Labs services for polysaccharide production include fermentation, extraction, purification, and lyophilization for either reagent grade or GMP manufacturing up to a 100L scale.  List Labs can provide the following custom services for your project:

  • Crude Polysaccharide Extracts
  • Process Development (Fermentation, Extraction, Purification, Lyophilization, and Scale Up)
  • GMP Manufacturing
  • QC Analytical Development

GMP

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 and CDC Select Agent registration enabling us to produce drug substance and drug products for our clients.

List Labs has manufactured a variety of bacterial toxins and proteins, live biotherapeutics products (LBS), 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).

For more information, see our GMP services page.

QC Analytical Testing

List Labs has the following analytical capabilities:

  • Endotoxin
  • KDO Assay
  • Nucleic Acid Concentration
  • Protein Concentration
  • Phosphate Concentration

Click on the icon below for a full list of our QC Analytical Testing.