resDetect™ GENIUS™ Nuclease ELISA Kit (Residue Testing)
产品参数（Product Specifications）
Assay Type | Sandwich-ELISA |
Analyte | Nuclease |
Format | 96T (8×12 strips) |
Reactivity | / |
Regulatory Status | RUO |
Sensitivity | ＜25 pg/mL |
Standard Curve Range | 25 pg/mL-800 pg/mL |
Assay Time | 3 hr 20 min |
Suitable Sample Type | For the quantitative determination the residue of nuclease in biologicals. |
Sample volume | 100 μL |
产品概述（Product Overview）
GENIUS™ Nuclease ELISA Kit (Residue Testing) is based on the ELISA sandwich method and is used to detect and quantitatively determine GENIUS™ Nuclease residues in biological products. It is designed to provide a reliable solution for quality assessment of biological products during drug development and CMC quality control stages. Additionally, it can be used as a universal detection tool for the quantitative determination of GENIUS™ Nuclease.
重构方法（Reconstitution）
Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.
存储（Storage）
1. Unopened kit should be stored at 2℃-8℃ upon receiving.
2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.
3. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
组分（Materials Provided）
ID | Components | Size |
CRS031-C01 | Pre-coated Anti-Nuclease Antibody Microplate | 1 plate (8×12 strips) |
CRS031-C02 | Nuclease Standard | 5 μg |
CRS031-C03 | Biotin-Anti-Nuclease Antibody | 20 μg |
CRS031-C04 | Streptavidin-HRP | 50 μL |
CRS031-C05 | 10×Washing Buffer | 50 mL |
CRS031-C06 | 2×Dilution Buffer | 50 mL |
CRS031-C07 | Substrate Solution | 12 mL |
CRS031-C08 | Stop Solution | 7 mL |
背景介绍
核酸酶是生物制药下游纯化工艺中的关键加工助剂，广泛用于去除宿主细胞核酸。在重组蛋白、抗体、病毒载体及疫苗等生物制品的生产过程中，核酸酶通过高效降解宿主细胞释放的基因组DNA和RNA，显著降低工艺过程中的核酸残留风险，从而保障终产品的安全性。然而，核酸酶本身作为外源性杂质蛋白，若在纯化后未能被充分清除并残留于终产品中，可能引发免疫原性风险。因此，各国药监机构对生物制品中核酸酶残留量有严格的质控要求。
本试剂盒基于双抗体夹心ELISA原理，采用预包被抗核酸酶抗体的微孔板，配套生物素化检测抗体和链霉亲和素-HRP检测体系，可对生物制品样本中的GENIUS™核酸酶进行准确定量。试剂盒灵敏度小于25 pg/mL，标准曲线检测范围为25 pg/mL–800 pg/mL，批内及批间精密度均不超过15%，且不受样品基质效应干扰。该产品适用于抗体药物、疫苗、细胞与基因治疗产品等在工艺开发及CMC质控阶段的质量评估，为生物制品中核酸酶残留检测提供标准化解决方案。
关键字： Nuclease;Nuclease试剂盒;试剂盒;百普赛斯;ACROBiosystems;
百普赛斯集团ACROBiosystems Group（股票代码：301080）是成立于2010年的跨国生物科技公司，是为全球生物医药、健康产业领域提供关键生物试剂产品及解决方案的行业平台型基石企业。2021年在创业板上市。百普赛斯集团业务遍布全球，横跨亚洲、北美洲、欧洲，在中国、美国、瑞士等12个城市设有办公室、研发中心及生产基地。目前累计服务客户超6000家，与全球Top 20医药企业均建立了长期、稳定的合作伙伴关系。集团旗下拥有品牌ACROBiosystems百普赛斯、bioSeedin柏思荟、Condense Capital垦拓资本和ACRODiagnostics百斯医学等。