OverviewResiQuant® Recombinant Protein A Residue Detection Kit（ELISA Method）is used to quantitatively detect the residual natural or recombinant Protein A content in biopharmaceutical samples. 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 shed natural Protein A and recombinant Protein A, if you need detect alkaline-resistant recombinant Protein A, please choose our CRP00-302* series and CRP00-303* series kits.
1.Wide detection range: work range is 13.7-10000 pg/mL;
2.Easy to operate: Treat samples in a boiling water bath or mental bath;
3.Save time: sample processing only takes 10 minutes, and detection experiment takes about 2.5 hours;
4.High Sensitivity: the detection limit is 7 pg/mL, and the lower limit of quantification is 13.7 pg/mL;
5.High Precision: Intra-batch deviations were all ≤20%;
6.High Accuracy: sample spike recovery rate is in the range of 80%-120%;
7.Good Repeatability: within in the quantitative limit range, the CV values of sample concentrations within and between plates are ≤20%;
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. This product can quantitatively detect shed natural Protein A and recombinant Protein A, if you need detect alkaline-resistant recombinant Protein A, please choose our CRP00-302* series and CRP00-303* 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.
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%.
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.