ELISA 试剂盒

ELISA Kits from Repligen deliver the precision, reproducibility, and sensitivity required for the accurate quantitation of leached native Protein A, recombinant Protein A, the MabSelect SuRe™ ligand, the NGL-Impact® A ligand, the NGL COVID-19 Spike Protein Affinity Ligand, and LONG® R3 IGF-I.

  ACCURATE

Protein A 检测

Detection of leached Protein A at low limits is critical for accurate testing and reliable results. The Protein A ELISA Kits from Repligen deliver consistent recovery performance throughout the detection range of the assay across different process buffers.

  ACCURATE

Protein A Quantitation

尽管FDA没有发布针对脱落Protein A 可允许水平的说明,但是生产商必需对最终治疗性制剂中的Protein A污染物水平进行检测和定量。

Repligen提供的Protein A试剂盒由于其高分析回收率和灵敏度,已被多种商品化/临床阶段单克隆抗体和Fc融合蛋白治疗药物生产商用于产品质量以及工艺污染物的出厂检测。

  REPRODUCIBLE

可重复性

Repligen提供的Protein A ELISA试剂盒经证实具有重要的试剂盒间和试剂盒内一致性。可重复性见下表,针对重复样品及3种模式缓冲液,在分析的动态范围内具有高度精确性(%CV)。

The data above were acquired using the Dilute & Go method. In all cases the sample buffer/hIgG matrix was tested in triplicate at 6 different Protein A concentration levels in three independent assays. The precision (inter and intra assay) was determined for both the Recombinant Protein A and MabSelect SuRe™ kits. The common buffers used were100 mM Glycine, 100 mM Acetate, and 100 mM Citrate. All buffers were prepared at a pH of 3.0 and neutralized to pH 7.6 with Tris-base. Each contained 5 mg/mL of human polyclonal IgG.

  OPTIMIZED PROTOCOLS

样品制备方案

Repligen设计了3种样品制备方案,以最大限度地优化使用的简便性、速度以及检测和定量的限值。 

Dilute and Go™(稀释和运行)

  • 最大限度提高使用的简便性,节省分析运行时间,无需缓冲液置换步骤
  • 样品可直接稀释进行分析*

Boil and Boost™(煮沸和增强)

  • 提高样品输入浓度,并降低定量限值
  • Combines the low pH dissociation step with boiling (no buffer exchange step**)

原始方案

  • 适用于传统方法
  • 需要缓冲液置换步骤

*必需评估特异性基质,以确保适用性
**在Boil & Boost™方案中,某些缓冲液可能需要透析

ELISA 试剂盒

Click on the tabs to explore features of the different ELISA Kits by target ligand.

对于使用MabSelect SuRe 捕获步骤的下游工艺,Repligen提供市面上唯一含有SuRe配基标准品的试剂盒,以进行最准确的定量。

  • 准确匹配的Protein A 参考标准品(SuRe™配基)
  • 灵敏度0.1 ng/mL
  • 回收率:80-120%
  • 准确性 & 精确性:试剂盒间分析 +/- 10%,试剂盒内分析 +/- 15%

试剂盒包括:

  • 抗-protein A 包被的96孔板
  • 试剂A:样品稀释液(5X)
  • 试剂B:MabSelect SuRe™ 标准品溶液
  • 试剂C:兔抗-protein A:生物素探针
  • 试剂D:链霉亲和素:过氧化物酶偶联物
  • 试剂E:TMB过氧化物酶底物
  • PBS包(数量2)

For downstream processes that utilize a Praesto® Jetted A50 capture step, Repligen offers the only kit on the market that includes the NGL-Impact® A Ligand standard for the most accurate quantitation.

  • Exact matched Protein A reference standard (NGL-Impact® A Ligand)
  • 灵敏度0.1 ng/mL
  • 回收率:80-120%
  • 准确性 & 精确性:试剂盒间分析 +/- 10%,试剂盒内分析 +/- 15%

试剂盒包括:

  • 抗-protein A 包被的96孔板
  • 试剂A:样品稀释液(5X)
  • Reagent B: NGL-Impact® A standard solution
  • 试剂C:兔抗-protein A:生物素探针
  • 试剂D:链霉亲和素:过氧化物酶偶联物
  • 试剂E:TMB过氧化物酶底物
  • PBS包(数量2)

The LONG® RIGF-I ELISA Kit is the only commercially available kit for the quantitation of LONG® RIGF-I. Fast, accurate, and easy to use with both cell culture and drug substance samples, this sandwich ELISA kit uses a biotinylated secondary antibody and Streptavidin-HRP for detection.

  • 对天然或重组IGF-1有限的反应性
  • 对胰岛素无反应性
  • 即用型ELISA板,可允许立即进行分析,而不需要额外的包板及封闭步骤

试剂盒包括:

  • LONG® R3 IGF-I coated strip plate, 96 wells
  • LONG® R3 IGF-I Standard
  • 稀释液
  • 生物素化检测抗体
  • 链霉亲和素过氧化物酶
  • TMB过氧化物酶底物
  • LoBind® 1.5mL EP管

For downstream processes that utilize a Praesto® Jetted A50 Hi pH capture step, Repligen offers the only kit on the market that includes the NGL-Impact® A Hi pH Ligand standard for the most accurate quantitation.

  • Exact matched Protein A reference standard (NGL-Impact® A Hi pH Ligand)
  • 灵敏度0.1 ng/mL
  • 回收率:80-120%
  • 准确性 & 精确性:试剂盒间分析 +/- 10%,试剂盒内分析 +/- 15%

试剂盒包括:

  • 抗-protein A 包被的96孔板
  • 试剂A:样品稀释液(5X)
  • Reagent B: NGL-Impact® A Hi pH Ligand standard
  • 试剂C:兔抗-protein A:生物素探针
  • 试剂D:链霉亲和素:过氧化物酶偶联物
  • 试剂E:TMB过氧化物酶底物
  • PBS包(数量2)

对于使用Protein A捕获步骤(非MabSelect SuRe™)的下游工艺,Repligen提供对残留的天然和重组Protein A (rPA)具有广泛识别性的Protein A ELISA试剂盒。

  • 针对所有天然和重组Protein A异构体的特异性
  • 灵敏度0.1 ng/mL或0.8 ppm
  • 回收率:80-120%
  • 准确性和精确性:试剂盒间+/-10%,试剂盒内+/-15%

试剂盒包括:

  • 抗-protein A 包被的96孔板
  • 试剂A:样品稀释液(5X)
  • 试剂B:重组Protein A标准品溶液
  • 试剂C:兔抗-protein A:生物素探针
  • 试剂D:链霉亲和素:过氧化物酶偶联物
  • 试剂E:TMB过氧化物酶底物
  • PBS包(数量2)

Manufacturing Centers of Excellence

Repligen在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品,以确保我们客户的业务连续性。

Repligen manufacturing sites are located in Massachusetts, California, and New Jersey in the United States and in Sweden, France, The Netherlands,  Germany and Estonia.

地点

客户至上。

Repligen DNA 为您提供支持。我们的目标是提供卓越的客户体验,并为所有 Repligen 产品和服务高效成功的采用及实施提供支持。

  • Field Application Support
  • 客户服务
  • 现场服务工程师

还有问题吗?

 
MabSelect™, MabSelect SuRe™ and SuRe™ are registered trademarks of Cytiva, a Danaher Corporation Life Sciences company.