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5-Part Series

Published Apr 13, 2022

Develop a Smart HCP Kit Strategy

Host cell proteins (HCPs) are process-related impurities that are produced by the host organism during biologic manufacturing and production. A purification process is necessary to reduce the levels of HCPs in any biopharmaceutical product to ensure it is safe for patients. Analysis techniques like the enzyme-linked immunosorbent assay (ELISA) are conducted to quantify the remaining levels of HCPs after purification. This is a complex process that requires the right tools, expertise, and strategies. This series explains the process of HCP analysis in biologics development, the benefits of using ELISA kits, how to ensure security of supply for HCP reagents, and solutions for validating HCP ELISAs.  

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Develop a Smart HCP Kit Strategy

Develop a Smart HCP Kit Strategy

Host cell proteins (HCPs) are process-related impurities that are produced by the host organism during biologic manufacturing and production. A purification process is necessary to reduce the levels of HCPs in any biopharmaceutical product to ensure it is safe for patients. Analysis techniques like the enzyme-linked immunosorbent assay (ELISA) are conducted to quantify the remaining levels of HCPs after purification. This is a complex process that requires the right tools, expertise, and strategies. This series explains the process of HCP analysis in biologics development, the benefits of using ELISA kits, how to ensure security of supply for HCP reagents, and solutions for validating HCP ELISAs.  

Host cell proteins (HCPs) are process-related impurities that are produced by the host organism during biologic manufacturing and production. A purification process is necessary to reduce the levels of HCPs in any biopharmaceutical product to ensure it is safe for patients. Analysis techniques like the enzyme-linked immunosorbent assay (ELISA) are conducted to quantify the remaining levels of HCPs after purification. This is a complex process that requires the right tools, expertise, and strategies. This series explains the process of HCP analysis in biologics development, the benefits of using ELISA kits, how to ensure security of supply for HCP reagents, and solutions for validating HCP ELISAs.