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.
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.
Articles in this Series
Host Cell Protein Analysis in Biologics Development
Host Cell Protein Analysis in Biologics Development
ELISA: The Benchmark HCP Assay
ELISA: The Benchmark HCP Assay
Ensuring the Security of Supply for HCP Reagents for Drug Process Development and Manufacturing
Ensuring the Security of Supply for HCP Reagents for Drug Process Development and Manufacturing
Challenges and Solutions for Validating HCP ELISAs
Challenges and Solutions for Validating HCP ELISAs
