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.
OverviewResiQuant® Mycoplasma Detection Kit (Fluorescent Probe qPCR Method) is used in conjunction with ResiQuant® Mycoplasma DNA Extraction And Purification Kit (Magnetic Bead Method)（CAT. CRB00-0031/CRB00-0032）, it can qualitatively detect whether there is mycoplasma contamination in the main cell bank, working cell bank, virus seed batch and cell products.
This kit uses fluorescent probe qPCR technology to design primes probes in the conserved gene fragments of mycoplasma. Based on the sequence comparison results, it can quantitatively detect about 174 species of mycoplasma. The detection is highly specific, and bacteria closely related to mycoplasma (Lactobacillus, Clostridium, Streptococcus, etc.) and common engineering cells such as CHO, VERO, HEK293, etc. are not detected. Verified according to the relevant requirements of EP 2.6.7, JP XVIII and USP <77> for mycoplasma detection, the detection limit can reach 10 CFU/mL，which meets the detection sensitivity requirements of EP 2.6.7 for the NAT method instead of the culture method.
This kit introduces an uracil-N-glycosylase (UNG) anti-contamination system, which can effectively remove residual contamination of PCR products and avoid false positives caused by contamination of amplified products. This kit uses the FAM+HEX/VIC dual-channel detection method and include PC (positive control) and RC (recovery control), which are used to monitor detection sensitively and sample recovery to avoid false negatives. The reagent component contains the reference dye ROX, which is suitable for ABI fluorescence quantitative PCR instruments or other similar equipment, and plays the role of fluorescence reference light path correction.
For first-time use, it is recommended to conduct a sample suitability study, including matrix interference, detection limit and specificity. The mycoplasma nucleic acid content in low-level contamination samples（≤10 CFU/mL）does not conform to the normal distribution. This kit uses a 3-well reporting method with a confidence level of more than 90%.
Product Features
1.High Sensitivity: The detection limit is 10CFU/mL, compared with the culture method, the sensitivity is equivalent to or better than the culture method;
2.Wide Coverage: Approximately 174 species of mycoplasma can be detected;
3.False Positive Control: Use touch down qPCR technology to reduce non-specific amplification and background dryness, and introduce the UNG anti-pollution system to reduce contamination caused by amplification products; effectively avoiding false positives;
4.False Negative Control: Use a dual-channel detection method, including PC (positive control) and RC (recovery control), to monitor sample recovery and matrix interference to avoid false negatives;
5.Product Compliance: Verified in accordance with European Pharmacopoeia EP 2.6.7 and Japanese Pharmacopoeia JP G3, and meets regulatory requirements;
ApplicationThe kit is suitable for different types of samples from intermediate products to final products in the biopharmaceutical process. It can be used for qualitative detect Mycoplasma contamination when used in conjunction with the ResiQuant® Mycoplasma DNA Extraction and Purification Kit (Magnetic Bead Method)（CAT. CRB00-0031/CRB00-0032）,the detection limit can reach 10 CFU/mL.
OverviewMycoplasma is a common contaminant in mammalian cell culture processes, mycoplasma contaminant can cause changes in host cell DNA, RNA and protein expression, such as interruption of DNA and RNA synthesis and changes in membrane antigens, thus affecting cell growth and proliferation. ResiQuant® Mycoplasma DNA Extraction and Purification Kit (Magnetic Bead Method) effectively reduces the interference of cells and sample matrix through pretreatment and specific binding of magnetic beads, and can extract and purify trace amounts of mycoplasma DNA in biological samples. The extraction step is simple and only takes 2~3 hours. Used in conjunction with the ResiQuant® Mycoplasma DNA Detection Kit (Fluorescent Probe qPCR Method)（CAT. CRB00-1011/CRB00-1012）, it can achieve the purpose of rapid detection of mycoplasma.
ApplicationThe kit can be used for micro-extraction of mycoplasma nucleic acid from biological samples. It is suitable for samples such as cell culture supernatant, bovine serum, serum-free medium and cell cryopreservation fluid. It is also suitable for samples such as cell banks and therapeutic cells. Directly process cell samples of 1×106~1×107.
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.
