CHO HCP ELISA Kit, SKU: DD8102-P1
This kit is designed to detect residual host cell proteins in biological products (such as antibodies, recombinant proteins, vaccines, etc.) expressed in CHO cell lines..
 
Product Overview
This kit employs a fed-batch culture process, utilizing CHO cells to immunize goats to produce HCP-specific antibodies. Based on a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA), this kit is used to detect residual CHO-HCP in biopharmaceutical process samples. The ELISA plate wells are pre-coated with anti-CHO-HCP goat polyclonal antibodies. CHO-HCP calibrators and test samples are added to the solid-phase antibody-coated wells, followed by the addition of the detection antibody-HRP conjugate. Through a one-step incubation, residual CHO-HCP in the test sample is captured by the solid-phase antibody and simultaneously detected by the detection antibody, forming a "coated antibody-(CHO-HCP antigen)-detection antibody-HRP conjugate" complex. After washing to remove unbound substances, TMB substrate is added for color development. After the reaction, absorbance is measured at dual wavelengths of 450 nm and 630 nm. The absorbance of the sample is positively correlated with the amount of residual CHO-HCPs in the process sample. The concentration of CHO-HCPs in a sample can be calculated using dose-response curves.
 
Components
See Table 1 above.
 
Performance
High Coverage Rate
Exhibits broad recognition of HCPs across varying molecular weights and isoelectric points, achieving coverage rates >80% (82% by 2D-Western Blot; 95% by AAE-LC-MS). The antibody pair detects over 2000 distinct CHO HCPs and covers all 25 CHO high-risk HCP.
 
Figure 1. Broad recognition of HCPs across varying molecular weights and isoelectric points.
 
Excellent Kit Stability
Accelerated stability testing of the DD8102 CHO HCP ELISA Kit (Vazyme) at 37°C. After 10 days of accelerated, the sample reactivity decreased by less than 20%. Furthermore, all critical parameters – LOD, LOQ, accuracy, precision, and specificity – consistently met the product specifications.
 
Figure 2. Stability of the DD8102 CHO HCP ELISA Kit at 37°C.
 
 
Minimal Matrix Effects
Spike-and-recovery experiments were conducted with process samples of known concentration across various matrices. Vazyme's product demonstrated significantly lower matrix interference and higher accuracy compared to competitor kits, evidenced by smaller variations in detected concentrations and consistently acceptable recovery rates.
 
Figure 3. DD8102 CHO HCP ELISA Kit (Vazyme) demonstrated significantly lower matrix interference and higher accuracy compared to competitor kits
 
Superior Precision and Accuracy
Precision (intra- and inter-assay) and accuracy were evaluated using Quality Controls (QCs) at 5 concentrations prepared from process samples of known concentration. All coefficients of variation (CV) were below 15%, and all biases were within ±20%, confirming the assay meets requirements for precision and accuracy.
 
Table 2. Precision (intra- and inter-assay) and accuracy were evaluated using Quality Controls (QCs) at 5 concentrations prepared from process samples of known concentration.
 
Product User Manual
Manual_DD8102-P1 V25.1