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ResiQuant® HEK 293 HCP ELISA Kit （CRH00-3061）

ResiQuant® HEK 293 HCP ELISA Kit （CRH00-3061）

ResiQuant® HEK 293 HCP ELISA Kit

Catalog No.
 Size
CRH00-3061
 48T
CRH00-3062
 96T

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Overview performance Related application image Data and files literature Q&A COA

HEK 293 cells are derived from human embryonic kidney cells, which are widely used in protein production, production of virus-like particles in vaccines, and production of viral vectors because of their advantages of high transfection efficiency, ease of cultivation, and expression of proteins with a structure closest to that of proteins expressed in human-derived systems. Although biological products undergo a series of purification processes to remove the relevant HCP impurities, residual HCP impurities above a certain level may cause toxicity or immune response, therefore, the residual amount of 293 HCP should be controlled. The enzyme-linked immunosorbent assay (ELISA) method for the detection of host cell protein residues is simple, rapid and reliable. The Pharmacopoeia of the People's Republic of China, 2020 Edition, Part III, recommends that HCP be detected by the enzyme-linked immunosorbent assay (ELISA) method. This product is a double-antibody sandwich ELISA kit, the antibody used is from rabbit anti-293 HCP polyclonal antibody, and the antigen is the fermentation supernatant collection of 293 F cells (cell culture medium does not contain proteins), this product is suitable for the quantitative detection of host cell proteins in the biologics derived from HEK 293 and HEK 293F host cell sources, and the other types of HEK 293 cell lines are subject to applicability studies..
Before using the kit for the first time, it is recommended that a product suitability study be completed to confirm that there is no interference with the sample matrix and appropriate dilution conditions for the sample assay.

Product Features
1.Quantitative Range: 10.2~1000 ng/mL；
2.Sensitivity: The lower limit of detection(LOD) of 293 HCP is not higher than 5 ng/mL, the lower limit of quantification: 10.2 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: CHO, Vero, E.coli HCP assay values were below 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
Selection of representative 293 cell lines; simulation of actual sample preparation process;
High specificity
Antibody coverage of up to 88%; contains the vast majority of 293 HCPs (more than 1,000 HCPs in total), and the antibody recognizes 59 common risk HCPs in the antigen, 7 of them are high-risk HCPs;
Simple operation and stable results
Two-step design, simple and quick operation, stable results;
Supply chain security
Large batch output, short delivery time, stable supply;