ELISA Quantitation Kits

ELISA kits from Repligen are precise, reproducible and sensitive for accurate quantitation.

Click on the tabs to explore the different ELISA Kits from Repligen.

For downstream processes that utilize a Cytiva MabSelect SuRe™ or MabSelect SuRe LX Protein A capture step

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For downstream processes that utilize a Purolite Praesto® Jetted A capture step
 

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The only commercially available kit for the quantitation of LONG®R3 IGF-I cell culture supplement

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For downstream processes that utilize a Purolite Praesto® Jetted A HipH capture step

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For downstream processes which utilize a Protein A capture step (not including MabSelect SuRe™, PrismA or NGL)

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For downstream processes that utilize an AVIPure® AAV5 capture step

Note: AVIPure AAV2, AAV8 and AAV9 ELISA kits are available through Cygnus Technologies

 

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For downstream processes that utilize a Purolite Praesto Jetted 70 CH1 capture step

 

  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.

 graph showing recovery of leached Protein A ligand
graph showing recovery of leached MabSelect SuRe ligand
  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。

Because of their high assay recovery and sensitivity, Protein A ELISA Kits from Repligen are used in the product quality and process contaminant release testing of many monoclonal antibodies and Fc Fusion protein therapeutics.

  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 were 100 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
photo of a scientist running the ELISA assay kit in a lab hood.

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

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