OverviewThis kit uses the Taqman probe quantitative PCR method to quickly detect residual Escherichia coli (E.coli) host 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 Escherichia coli stains (such as E.coli-K12，E.coli-DH5α，E.coli-MC1061，E.coli-HB101，E.coli-AM-7，E.coli-XL1-Blue，E.coli-YK537, etc.) 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 E.coli host bacteria, 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 E.coli DNA residues. The quantitative detection range is 300 pg/μL to 30 fg/μL.
OverviewThis kit uses the Taqman probe quantitative PCR method to quickly detect residual Chinese Hamster Ovary (CHO) 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.
ApplicationThis kit is suitable for different sample from biopharmaceutical intermediates to final products, the detection results are accurate and reliable. It can quantitatively detect CHO DNA residues. The quantitative detection range is 300 pg/μL to 3 fg/μL.
OverviewResiQuant® Alkali-resistant Protein A Residue Detection Kit 2G（ELISA Method）can accurately quantify alkali-resistant recombinant Protein A. This product is a highly sensitive universal alkali-resistant Protein A quantitative detection kit, without interference, the lower limit of quantification can reach 4.9 pg/mL. Protein A includes natural Protein A, recombinant Protein A, and alkali-resistant recombinant Protein A which structure is significantly different from natural Protein A, such as GE’s MabSelect SuReTM Protein A. This product can quantitatively detect alkali-resistant recombinant Protein A. If you have higher requirements for sensitivity, please choose our CRP00-303* series kits. If you need to detect shed natural Protein A or recombinant Protein A, please choose our CRP00-301* series kits.
ApplicationIn the production and purification process of antibody products, Protein A affinity chromatography resin is a commonly used tool to separate and purify antibodies. However, during the antibody purification process, Protein A will fall off, causing antibody products contains Protein A, thus affecting the purity and potency of the product, causing major problems to the pharmaceutical industry. For example, the 2020 edition of the Chinese Pharmaceutical stipulates that the Protein A residue detected by enzyme-linked immunoassay for nimotuzumab injection should not be higher than 0.001% of the total protein, so the Protein A residue in biological products must be detected. Protein A includes natural Protein A, recombinant Protein A, and alkali-resistant recombinant Protein A which structure is significantly different from natural Protein A, such as GE’s MabSelect SuReTM Protein A. The CRP00-302* series kits of ExCell can perform quantitative detection of alkali-resistant recombinant Protein A. If you have higher requirement for sensitivity, please choose our CRP00-303* series kits, if you need to detect shed natural Protein A or recombinant Protein A, please choose our CRP00-301* series kits Please Attention! Before using this kit for the first time, it is recommended to complete a product suitability study to confirm whether there is interference in the sample matrix and the appropriate dilution conditions for sample detection.
