Overview与原核细胞、酵母细胞以及昆虫细胞相比，中国仓鼠卵巢细胞（CHO）作为宿主细胞表达的外源蛋 白最接近其天然构象，因而 CHO 细胞表达系统是生物工程制药最为理想的表达系统。在 CHO 细胞中表 达治疗性蛋白对于商业化的药物生产十分经济方便，但是这类产品的生产以及纯化过程有可能会带来 CHO 宿主细胞蛋白（CHO HCP）残留的污染，这些残留的蛋白污染会降低药物治疗效果，造成副作用或 者免疫反应，因此要对 CHO HCP 的残留量进行控制。《中华人民共和国药典》2020 年版三部建议 HCP 采用酶联免疫吸附测定（ELISA）方法检测。CHO HCP ELISA 检测试剂盒可以辅助蛋白纯化、过程控制、 质量控制等流程中 CHO 宿主细胞蛋白残留的控制，优化工艺流程，确保蛋白生产的安全进行。
首次使用本试剂盒前建议先完成产品的适用性研究，确认样本基质是否存在干扰以及合适的样本检测 稀释条件。
OverviewResiQuant® 耐碱性 Protein A 残留检测试剂盒2G（ELISA法）可准确定量耐碱性重组 Protein A。本产品是高灵敏度通用型耐碱性Protein A定量检测试剂盒，无干扰情况下，定量下限可达 4.9 pg/mL。Protein A包括天然 Protein A、重组 Protein A 以及结构与天然 Protein A 有显著区别的耐碱性重组 Protein A，如 GE 公司的 MabSelect SuReTM Protein A。本产品可对耐碱性重组 Protein A进行定量检测。如果您对灵敏度有更高要求，请选择我们的 CRP00-303*系列试剂盒。如果您需要检测脱落的天然 Protein A、重组 Protein A ，请选择我们的 CRP00-301*系列试剂盒。
Application本产品是通用型检测试剂盒，用于定量检测生物药样本中残留的 MabSelect SuReTM Protein A 浓度。
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.
