Biopharmaceutical quality control | HEK293 HCP Elisa Kit (One-step ELISA)
Why Residual Host Cell Protein Detection Matters
Derived from human embryonic kidney cells, HEK293 cells are extensively utilized in the manufacturing of biological therapeutics such as recombinant proteins and viral vectors, owing to their robust expression capabilities. Despite biological products undergoing multiple purification steps for impurity removal, trace residuals of host cell proteins (HCPs) may still trigger immunogenic responses in the body, disrupt drug bioactivity, compromise product stability, and even diminish therapeutic efficacy—posing potential risks to product quality and clinical safety. Therefore, precise detection of residual HEK293-derived HCPs introduced during the production process is a critical component to comply with biological product release standards.
HYASEN HEK293 HCP ELISA kit: Precision Meets Compliance
HYASEN HEK293 HCP ELISA kit provides the quantitative measurement of HCP contamination in recombinant proteins and CGT products from HEK293 and its derivative, e.g., HEK293T. The assay is fully validated and complies with pharmacological requirements. The quantitation standards and capture antibodies were characterized, and the coverage of HEK293 or HEK293T HCP antibodies to the antigen was validated by 2D and MS analyses. The assay performance met not only bioprocess development needs but also those of QC release test. Kit manufacturing complies with the ISO13485 quality standard.
HYASEN HCP Related Service Platform
HYASEN has built a comprehensive HCP testing and customization service platform to meet the needs of different application scenarios:
Other related products
Beyond HEK293 cells, HYASEN's HCP Detection product line also includes the following validated kits.
Each kit utilizes the same pharmacopoeial design philosophy, delivering consistent accuracy and reliability across diverse host systems. Collectively, these kits form a comprehensive residual protein detection solution that supports all stages of biopharmaceutical process validation.