OverviewHEK 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.
ApplicationResiQuant® HEK 293 HCP ELISA Kit is designed to quantify the residues of 293 host proteins in the production process of products manufactured by expressing 293 cell lines as host cells.
OverviewPlasmids are closed-loop, double-stranded, superhelical DNA molecules that are widely used in vaccine preparation and cellular gene therapy (CGT), such as DNA vaccines, naked plasmid gene vectors, adeno-associated viruses (AAVs) and lentiviral vectors, etc. Usually, plasmids are produced in Escherichia coli (E.coli) as the host, and the most representative host bacteria are DH5a, Stbl3, Top10 and other strains derived from E.coli K-12. In the process of plasmid production and purification, there may be contamination of E.coli host cell protein (E.coli HCP) residues, and these residual HCPs may bring risks to the subsequent application of the plasmid, such as generating an immune response in vivo, so the amount of E.coli HCP residues should be controlled. Unlike the conventional process of expressing recombinant proteins using E.coli, the most commonly used process for plasmid production and purification is the alkaline lysis process. The antigen used in this kit is denatured E.coli HCP prepared based on the E.coli alkaline cleavage process, and the exclusive antibody is obtained by immunizing animals with E.coli HCP using the alkaline cleavage process. This product is suitable for quantitative detection of E.coli HCP in plasmid intermediates, stock solutions and final products extracted by the alkaline lysis process.
ApplicationResiQuant® E.coli HCP ELISA Kit is a universal assay kit for the quantitative detection of E.coli HCP in plasmid intermediates, stock solutions and final products extracted by alkaline lysis process.
OverviewCompared 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.
ApplicationResiQuant® CHO HCP ELISA Kit (FAST) is a universal assay kit that is designed to quantify the residues of CHO host proteins during the production process of products manufactured by expression of CHO cell lines as host cells.
OverviewThis kit uses the Taqman probe quantitative PCR method to quickly detect residual human embryonic kidney cell 293 (HEK 293) host cell DNA in intermediates, semi-finished products and finished products of various biological products and pharmaceuticals. The kit introduces an uracil-N-glycosylase (UNG) system, which can effectively remove residual contamination of PCR products and great reduce false positives caused by contamination of amplified products. The reagent components contain internal standard control (IC), we can monitor whether the reaction process is proceeding normally and eliminate sample interference; ROX is suitable for ABI fluorescence quantitative PCR instruments or other similar equipment, and plays a role in optical path correction.
This product is suitable for biology drug solutions, finished products, semi-finished products, intermediate products or process monitoring samples produced with human embryonic kidney cell 293 stain as host. To obtain a calibration curve for quantitative sample DNA, the kit contains DNA calibrators with 5 concentration gradients (300 pg/μL to 30 fg/μL) for preparation of calibration curve.
For the extraction of residual DNA from HEK293 host cells, it is recommended to use our company’s universal residual host DNA sample pretreatment kit. Before first use, it is recommended to complete a product suitability study: confirm whether there are interferences or inhibitors in the sample or sample matrix, and select appropriate sample detection dilution conditions.
ApplicationThis kit is suitable for different sample from biopharmaceutical intermediates to final products, the detection results are accurate and reliable. It can quantitatively detect 293 DNA residues. The quantitative detection range is 30 fg/μL to 300 pg/μL.
