5 services found
SGS M-SCAN Ltd services
Adventitious Agent and Mycoplasma Testing Services
Adventitious agent and mycoplasma testing services from SGS – biologics safety testing to ensure that your cell cultures, virus stocks and final products are certified free from contaminating agents, such as endotoxins and viruses. During the development of your biopharmaceutical products, the threat of cell culture contamination by adventitious agents such as mycoplasma, endotoxins and viruses, should not be underestimated. We offer you comprehensive testing for a range of contaminants at every stage of your drug development and production process.
Host Cell Impurity Testing
Host cell proteins are the biggest protein contaminant in biopharmaceuticals that have been derived by recombinant DNA-technology, and they require protein recovery processes to minimize their content in a final product. They are also often immunogenic and pose risks to both the efficacy of a drug and patient safety. Host cell DNA levels are also a contaminant, and regulatory bodies such as the World Health Organization, the EU and the FDA have set maximum levels that they consider safe in products.
Molecular Biology Services
Molecular biology services from SGS – retrovirus testing and lot release testing to ensure that the biological starting materials and mammalian cell substrates used in your drug products are free from contaminating viruses. Quality control and lot release testing of drug products is a critical part of your biological manufacturing process. Our molecular biology services help you to ensure that final products derived from continuous mammalian cell lines contain acceptable levels of residual host cell DNA (HCD). We can also help you to ensure that biological starting materials and mammalian cell substrates are free from contaminant viruses, including retroviruses.
Transmission Electron Microscopy Services
Transmission electron microscopy services from SGS – helping you detect and quantify virus particles throughout the biopharmaceutical and vaccine manufacturing process. During the manufacturing process, you need to ensure that your vaccine and biopharmaceuticals are free from virus particles. Our transmission electron microscopy (TEM) services, including negative staining and thin section electron microscopy techniques, help to detect adventitious agents throughout your biopharmaceutical and vaccine manufacturing process.
Water System Validation
Purified water is a key component in the manufacturing of virtually all pharmaceutical products. Water purification systems must be validated to ensure that the specified quality of water is consistently produced. SGS is the leading provider of laboratory water testing and pharmaceutical water system validation services. If manufacturing plants are located near any of SGS’s Life Sciences Services laboratories, our technicians can perform the sampling for you. Alternatively, your staff can collect the samples and ship them to an SGS laboratory for analysis. We can supply containers for collecting water samples.
