OverviewResiQuant® Residual Host DNA Sample Pretreatment Kit (Magnetic Bead Method) is used to extract host cell DNA from biopharmaceutical raw materials, finished products, semi-finished products, intermediates product and process monitoring samples produced by different cell lines such as CHO, E.coli, Human, Vero, Pichia, NS0 and MDCK .The pretreatment kit uses chemical lysis and magnetic beads to extract genomic DNA from different types of samples, including samples with high protein and low DNA concentration ,which can effectively extract and purify trace amounts of DNA.
ApplicationResiQuant® Residual Host DNA Sample Pretreatment Kit (Magnetic Bead Method) can extract trace amounts of residual host cell genomic DNA from intermediate products to finished products in the biopharmaceutical production process ,and is suitable for various commonly used host cell types.
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.
