Profacgen will perform your experiments based on the requirements of ICH. The determination of mutagenicity is mainly based on the results of the bacterial mutation test (Ames). Carcinogenicity is determined by the results of animal carcinogenicity tests and human carcinogenicity related evidences. In addition, other non-mutagenic genotoxic substances usually have a threshold mechanism. Such impurities usually do not pose a carcinogenic risk to humans when they exist at a certain level.
https://www.profacgen.com/genotoxic-impurities-analysis.htm
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Profacgen offers a full range of biopharmaceutical development and bio-manufacturing services that cover strategic consultancy, world-class process development, cGMP manufacturing, and analytical development.
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