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Ensuring Biopharmaceutical Purity through Advanced Host Cell Protein Testing and Comprehensive Impurity Profiling
Host Cell Protein (HCP) testing is a critical quality control process used to detect residual proteins left over from the biological manufacturing of drugs.
In the biopharmaceutical sector in China, the removal of HCPs is essential to ensure patient safety and drug stability. Even trace amounts of proteins from host cells, such as Chinese Hamster Ovary (CHO) cells, can provoke an immune response or degrade the therapeutic molecule. Group discussions among laboratory managers often center on the "coverage" of Enzyme-Linked Immunosorbent Assays (ELISA), which are the gold standard for quantifying total HCP load during various stages of purification.
As manufacturing standards rise, there is a significant move toward "orthogonal" testing methods. Mass spectrometry and two-dimensional electrophoresis are increasingly discussed as ways to identify specific "hitchhiker" proteins that traditional ELISA might miss. These advanced tools allow for a more granular understanding of the impurity profile, which is a requirement for regulatory…