products
ELISA Kits
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® ligands, AVIPure ligands, and LONG® R3 IGF-I.
product features
Reproducible
Optimized Protocols
ELISA Quantitation Kits
ELISA kits from Repligen are precise, reproducible and sensitive for accurate quantitation.
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.
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
Resources
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