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Host Cell and Process Related Impurities

Identify and Quantify Host Cell and Process Related Impurities

Bacterial and mammalian cells are commonly used as host systems for the production of human therapeutic proteins. An important part of the purification process is the removal of host cell material, such as DNA or proteins, which can pose a safety concern if administered along with the therapeutic compound. The production of biopharmaceuticals also includes the use of purification buffers and solvents during manufacturing, as well as those that leach from the hardware used to produce and purify drugs.

Agilent Technologies offers reliable solutions for the accurate measurement of host cell DNA using our qPCR system and identification and quantitation of host cell proteins using LC/MS. Agilent also provides a comprehensive portfolio of solutions for determining process related impurities such as metals and residual solvents using ICP/OES, ICP/MS, GC headspace analyzers, and GC/MS platforms.