ELISA Quantitation Kits

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

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Part Number Affinity Ligand Corresponding Affinity Resin/Application Performance Summaries
9000-1 Native and Recombinant Protein A For downstream processes which utilize a Protein A capture step (not including MabSelect SuRe™, PrismA or NGL) See the data
9222-1 NGL-Impact® A For downstream processes that utilize a Purolite Praesto® Jetter A capture step See the data
9777-1 NGL-Impact A® HipH For downstream processes that utilize a Purolite Praesto® Jetter A HipH capture step  
9333-1 MabSelect SuRe™ For downstream processes that utilize a Cytiva MabSelect SuRe™ or MabSelect SuRe™ LX Protein A capture step See the data
9-EL-0060 NGL-Impact A DurA™ For downstream proccesses that utilize a Purolite NGL-Impact® A DurA™ capture step  
9-EL-0040 NGL-IMPACT CH1 For downstream proccesses that utilize Purolite Praesto® Jetter 70 CH1 capture step  
9-EL-0020 AVIPure® AAV5 Affinity For downstream processess that utilize an AVIPure® AAV5 capture step
Note: AVIPure AAV2, AAV8 and AAV9 ELISA Kits are available through Cygnus Technologies
 
9-EL-0070 AVIPure® Albumin For downstream processes that utilize an AVIPure® Albumin capture step  
9547-1 LONG® R3 IGF-I The only commercially available kit for the quantification of LONG® R3 IGF-I cell culture supplement See the data

 

 ACCURATE

Protein A detection

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
ACCURATE

Protein A Quantitation

Although the FDA does not publish a limit on allowable levels of leached Protein A, manufacturers must characterize and quantitate the levels of Protein A contaminants in the final therapeutic formulation.

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

Reproducibility

The Protein A ELISA Kits from Repligen demonstrate critical inter- and intra-kit consistency. Reproducibility is demonstrated below, with the high degree of precision (% CV) throughout the dynamic range of the assay within replicate samples and across three model buffers.

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

Sample preparation protocols

Repligen has designed three sample preparation protocols to maximize ease of use, speed, and limits of detection and quantitation. 

Dilute and Go™

  • Maximize ease of use and assay run time with no buffer exchange step
  • Sample can be diluted directly into the assay*

Boil and Boost™

  • Increase sample input concentration and decrease limit of quantitation
  • Combines the low pH dissociation step with boiling (no buffer exchange step**)

Original Protocol

  • Suitable for legacy methods
  • Requires a buffer exchange step
photo of a scientist running the ELISA assay kit in a lab hood.
 

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

* Must evaluate specific matrices for feasibility
** Some buffers may require dialysis in the Boil & Boost protocol