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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. These host cell materials can potentially pose a safety concern if administered along with the therapeutic compound. Process related impurities are by products of the biopharmaceuticals production and manufacturing process. These impurities can come from the purification buffers and solvents used 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 qPCR system. LC/MS can also be used to help with the identification and quantitation of host cell proteins. Agilent also provides a comprehensive portfolio of solutions for determining process related impurities such as metals and residual solvents with the use of ICP/OES, ICP/MS, GC headspace analyzers, and GC/MS platforms.