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ResiQuant® CHO HCP ELISA Kit （CRH00-3051）

ResiQuant® CHO HCP ELISA Kit （CRH00-3051）

ResiQuant® CHO HCP ELISA Kit （FAST)

Catalog No.
Size
CRH00-3051
 48T
CRH00-3052
 96T


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Compared with prokaryotic cells, yeast cells and insect cells, the therapeutic proteins expressed by Chinese hamster ovarian cell (CHO) as host cells are closest to its natural conformation, so the CHO cell expression system is the most ideal system for biopharming. The expression of therapeutic proteins in the CHO cell line is economical and convenient for commercial drug production, but it leaves the potential impurities by host cell proteins (HCPs) from CHO cells, which may reduce the efficacy of drug therapy and cause side effects or immune reactions. Therefore, the residual amount of CHO HCP should be controlled. The Chinese Pharmacopoeia (ChP) suggested that HCP should be detected by enzyme-linked immunosorbent assay (ELISA). This product is a double-antibody sandwich ELISA kit. The antibody used is from rabbit and goat, and the antigen is the fermentation supernatant of CHO cells (cell medium does not contain protein). The kit offers valuable assistance in not only controlling the residual amount of CHO HCP in protein purification, process control, and quality assurance but also in optimizing the development of the purification process, to ensure the safety of target proteins productions.
Before using the kit for the first time, it is recommended to complete the suitability study of product to confirm the sample matrix effect and the appropriate dilution conditions for sample testing.

Product Features
1.Quantitative Range: 1.0~250 ng/mL；
2.Sensitivity: The lower limit of detection(LOD) of CHO HCP is less than 0.5 ng/mL, the lower limit of quantification(LOQ) is 1.0 ng/mL；
3.Precision: The coefficient of variation(CV) for sample concentrations within the quantification range is less than 20% both intra-assay and inter-assay；
4.Specificity: The concentration of CHO HCP in E.coli, 293T, Vero and other cell supernatants as well as non-CHO expressed human IgG samples are all lower than the lower limit of detection；

Product Advantages
Complete traceability system for reagent kits
Independent preparation and development of components (calibrators and antibodies),independent control of raw materials, and perfect traceability system of reagent kits;
HCP preparation process is representative
Representative CHO-S, CHO-K1 cell lines were selected; the recombinant antibody preparation process was simulated, and secretion supernatants were used;
High specificity
Antibody coverage of up to 84%; contains the vast majority of CHO HCPs (nearly 2,000 HCPs), with antibodies recognizing 69 common risk HCPs in the antigen; of these, 22 account for high-risk HCPs;
Simple operation and stable results
Ready-to-use calibrators, avoiding differences in dilution of the standard curve; one-step design, simple and fast operation;
Supply chain security
Large batch output, short delivery time, stable supply;