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The CHO Lysate HCP ELISA Kit, 2G is a simple-to-use, objective, and semi-quantitative ELISA kit intended for use in determining the presence of host cell protein impurities in products manufactured by expression in CHO cells. This kit is specifically designed to monitor HCP in a process where the CHO cells are lysed as part of the downstream process to recover the product protein of interest. Cygnus CHO HCP ELISA, 3G, Item # F550-1, should be used when the protein of interest is secreted into the culture media. The antibodies used in this 2nd generation CHO Lysate HCP ELISA Kit, F1045, have been raised against and affinity purified using a mild lysate of CHO cells. The antibodies were characterized by Antibody Affinity Extraction (AAE) and Mass Spectrometry, demonstrating 96% coverage to HCPs in CHO lysate. This kit has LOD ~0.7 ng/ml and LLOQ ~3ng/ml. It was qualified for testing of final product HCPs by using actual in-process and final drug substance samples. Each user of this kit is encouraged to perform a similar qualification study to demonstrate it meets their analytical needs.
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