Overview與原核細胞、酵母細胞以及昆蟲細胞相比，中國倉鼠卵巢細胞（CHO）作為宿主細胞表達的外源蛋 白最接近其天然構象，因而 CHO 細胞表達系統(tǒng)是生物工程制藥最為理想的表達系統(tǒng)。在 CHO 細胞中表 達治療性蛋白對于商業(yè)化的藥物生產十分經濟方便，但是這類產品的生產以及純化過程有可能會帶來 CHO 宿主細胞蛋白（CHO HCP）殘留的污染，這些殘留的蛋白污染會降低藥物治療效果，造成副作用或 者免疫反應，因此要對 CHO HCP 的殘留量進行控制。《中華人民共和國藥典》2020 年版三部建議 HCP 采用酶聯(lián)免疫吸附測定（ELISA）方法檢測。CHO HCP ELISA 檢測試劑盒可以輔助蛋白純化、過程控制、 質量控制等流程中 CHO 宿主細胞蛋白殘留的控制，優(yōu)化工藝流程，確保蛋白生產的安全進行。
首次使用本試劑盒前建議先完成產品的適用性研究，確認樣本基質是否存在干擾以及合適的樣本檢測 稀釋條件。
OverviewResiQuant? 耐堿性 Protein A 殘留檢測試劑盒2G（ELISA法）可準確定量耐堿性重組 Protein A。本產品是高靈敏度通用型耐堿性Protein A定量檢測試劑盒，無干擾情況下，定量下限可達 4.9 pg/mL。Protein A包括天然 Protein A、重組 Protein A 以及結構與天然 Protein A 有顯著區(qū)別的耐堿性重組 Protein A，如 GE 公司的 MabSelect SuReTM Protein A。本產品可對耐堿性重組 Protein A進行定量檢測。如果您對靈敏度有更高要求，請選擇我們的 CRP00-303*系列試劑盒。如果您需要檢測脫落的天然 Protein A、重組 Protein A ，請選擇我們的 CRP00-301*系列試劑盒。
Application本產品是通用型檢測試劑盒，用于定量檢測生物藥樣本中殘留的 MabSelect SuReTM Protein A 濃度。
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.
Product Advantages
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.
