Product/Service

Mycoplasma Testing

Source: SGS Life Sciences Services
SGS' Life Science Services offers various validated test methods that can reliably detect Mycoplasma contamination in a variety of sample materials. SGS Life Sciences

SGS' Life Science Services offers various validated test methods that can reliably detect Mycoplasma contamination in a variety of sample materials.

Mycoplasma contamination of cell cultures and virus stocks is a serious and widespread problem. Mycoplasmas have been shown to alter virtually every cellular process, including hybridoma selection rates, protein and nucleic acid synthesis, immunogenicity, chromosomal breakage and production of virus and biologicals. Mycoplasma infection may not only lead to unreliable experiments in biomedical and biotechnological research, but also causes significant productivity losses in biological manufacturing.

Regular testing for Mycoplasma contamination is required by the regulatory authorities in biopharmaceutical and biotechnological production to ensure biosafety of biologicals and biopharmaceuticals.

Mycoplasma Test Methods:

  • Mycoplasma Test on agar and broth (compliance with 21 CFR 610.30 and EP 2.6.7.)
  • PCR based test (endpoint and real-time PCR)
  • Test on indicator cells and DNA fluorochrome staining (compliant with FDA points to consider, 1993 and EP 2.6.7.)
  • Identification of Mycoplasma strains (DNA sequencing)

Sample Material:

  • Biopharmaceutical samples (Culture media, raw materials, intermediate products, API, bulk drugs, finished products)
  • Cell banks
  • Culture media