Product/Service

Host Cell Impurity Testing

Source: SGS Life Sciences Services
SGS' Life Science Services provide you with sufficiently sensitive test methods to detect host cell impurities. Additionally, SGS has the capabilities to develop specific host cell protein assays for your expression cell line.

SGS' Life Science Services provide you with sufficiently sensitive test methods to detect host cell impurities. Additionally, SGS has the capabilities to develop specific host cell protein assays for your expression cell line.

Host Cell Proteins (HCPs) comprise the major protein contaminants associated with biopharmaceuticals derived by recombinant DNA-technology. Protein recovery processes are required to minimize the content of HCPs in the final product. Host cell proteins are often immunogenic and can alter the therapeutic efficacy of a drug or can affect patient safety.

Host cell DNA levels are another cellular contaminant present in biopharmaceuticals. The WHO, the EU and the FDA have set specific levels of residual host cell DNA that are acceptable in biopharmaceutical products.

Host Cell Impurity Tests:

  • Host Cell Protein Assays
    • ELISA
    • ILA (Immunoligand Assay)
    • SDS-PAGE
    • Immunoblotting
  • Host Cell DNA Assays
    • Quantitative PCR
    • Dot-Blot Hybridization
  • Production of antibodies against "null cells"
    • Immunization