Most accurate matched standard for MabSelect SuRe™ resin
Consistent inter- and intra-kit consistency
Using biotinylated rabbit anti-Protein A detection antibody
Using polyclonal chicken capture antibody
With three proven sample preparation protocols
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.
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.
For downstream processes which utilize a Protein A capture step (non-MabSelect SuRe™), Repligen offers the Protein A ELISA Kit suitable for Protein A resins that contain native and recombinant Protein A ligand variants.
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
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.
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™
* 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.