CHO Host Cell Protein (High Sensitivity) ELISA Kit

• ~94% antibody coverage by 4D-DIA LC-MS (~1,700 CHO proteins assessed)
• All 17 priority high-risk HCPs detected, including : PLBL2 · Clusterin · LPL · Cathepsins B/D/Z
• ICH Q2(R2) 2023 method validation report available upon request

The CHO Host Cell Protein (High Sensitivity) ELISA Kit is a quantitative sandwich immunoassay for measuring residual Chinese Hamster Ovary (CHO) host cell protein (HCP) impurities in biologics manufactured by recombinant expression in CHO cells. This kit uses a proprietary mix of polyclonal chicken IgY antibodies raised against CHO HCPs from CHO-S, CHO-K1 and Expi-CHO cell lines. Designed for use in process development, manufacturing process control, and product release testing, the kit employs a two-step sequential sandwich format: samples are first captured on wells pre-coated with chicken IgY anti-CHO HCP antibody, followed by sequential addition of a biotin-labeled chicken IgY detection antibody and Streptavidin-HRP conjugate, delivering a robust colorimetric signal proportional to the HCP content.

Method validation as per ICH Q2(R2) 2023 guidelines. The method validation report is available upon request. Suitable for Research and Manufacturing Use.

Chinese Hamster Ovary (CHO) cells are widely used to produce biologics, but they also produce host cell proteins (HCPs) that must be removed during downstream purification. Residual HCPs are process-related impurities that can affect product quality through immunogenicity, product instability, or enzymatic activity. ENZ-KIT268 provides a sensitive ELISA-based solution for routine CHO HCP quantification of these impurities.