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.

SGS host cell impurity testing is a vital service for quality and safety assurance in your products. Conducted by experts in one of our highly equipped laboratories across the globe, they help you demonstrate the safety by showing whether host cell impurities fall within acceptable levels.

SGS provides you with sufficiently sensitive test methods to detect host cell impurities, and has the capabilities to develop specific host cell protein assays for your expression cell line. Our tests include:

• Host cell protein assays––ELISA, ILA (Immunoligand Assay), SDS-PAGE and immunoblotting
• Host cell DNA assays––quantitative PCR and dot-blot hybridization
• Production of antibodies against ‘nul cells’––immunization

SGS is the world’s leading inspection, verification, testing and certification company, and our testing services are being continuously improved so that they remain the best in their class. By outsourcing your host cell impurity testing activity, you are placing your trust in a tried-and-tested contract research organization that already partners with major players across the Life Sciences.

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