Most accurate matched standard for MabSelect SuRe™ ligand
Consistent inter- and intra-assay precision
Three proven sample preparation methods
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
For downstream processes that utilize a MabSelect SuRe™ capture step, Repligen offers the only kit on the market that includes the SuRe™ ligand standard for the most accurate quantitation.
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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.
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For downstream processes that utilize a Protein A capture step (non-MabSelect SuRe™), Repligen offers a Protein A ELISA Kit with broad recognition of residual native and recombinant Protein A (rPA).
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For downstream processes that utilize NGL COVID-19 Spike Protein Affinity Resin, Repligen offers the only kit on the market that includes the NGL COVID-19 Spike Protein Affinity Ligand standard for the most accurate quantitation.
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The LONG®R3 IGF-I ELISA Kit is the only commercially available kit for the quantitation of LONG®R3 IGF-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
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For downstream processes that utilize a Praesto® Jetted A50 HipH capture step, Repligen offers the only kit on the market that includes the NGL-Impact® A HipH Ligand standard for the most accurate quantitation.
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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.
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 commercial/clinical stage monoclonal antibodies and Fc Fusion protein therapeutics.
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 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.
Repligen has designed three sample preparation protocols to maximize ease of use, speed, and limits of detection and quantitation.
Dilute and Go™
Boil and Boost™
Original Protocol
* Must evaluate specific matrices for feasibility
** Some buffers may require dialysis in the Boil & Boost protocol
MabSelect™, MabSelect SuRe™ and SuRe™ are registered trademarks of GE Healthcare.