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® A ligand, the NGL COVID-19 Spike Protein Affinity Ligand, and LONG®R3 IGF-I.
Accurate
Most accurate matched standard for MabSelect SuRe™ ligand
Reproducible
Consistent inter- and intra-assay precision
optimized protocols
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.
PROTEIN A ELISA KIT FOR MabSelect SuRe™ LIGAND
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.
- Exact matched Protein A reference standard (SuRe™ ligand)
- Sensitivity of 0.1 ng/mL
- Recovery: 80-120%
- Accuracy & Precision: Inter-assay +/- 10%, Intra-assay +/- 15%
Kit Contents:
- Anti-protein A coated 96 well microtiter plate
- Reagent A: sample diluent (5x)
- Reagent B: MabSelect SuRe™ standard solution
- Reagent C: rabbit anti-protein A: biotin probe
- Reagent D: streptavidin: peroxidase conjugate
- Reagent E: TMB peroxidase substrate
- PBS packs (quantity 2)
Protein A ELISA Kit for NGL-Impact® A Ligand
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.
- Exact matched Protein A reference standard (NGL-Impact® A Ligand)
- Sensitivity of 0.1 ng/mL
- Recovery: 80-120%
- Accuracy & Precision: Inter-assay +/- 10%, Intra-assay +/- 15%
Kit Contents:
- Anti-protein A coated 96 well microtiter plate
- Reagent A: sample diluent (5x)
- Reagent B: NGL-Impact® A standard solution
- Reagent C: rabbit anti-protein A: biotin probe
- Reagent D: streptavidin: peroxidase conjugate
- Reagent E: TMB peroxidase substrate
- PBS packs (quantity 2)
Protein A ELISA Kit for Native and Recombinant Protein A
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).
- Specificity for all variants of native and recombinant Protein A
- Sensitivity of 0.1 ng/mL or 0.8 ppm
- Recovery: 80-120%
- Accuracy and precision: Inter-assay +/- 10%, Intra-assay +/- 15%
Kit Contents:
- Anti-protein A coated 96-well microtiter plate
- Reagent A: sample diluent (5x)
- Reagent B: recombinant protein A standard solution
- Reagent C: rabbit anti-protein A: biotin probe
- Reagent D: streptavidin: peroxidase conjugate
- Reagent E: TMB peroxidase substrate
- PBS packs (quantity 2)
NGL COVID-19 Spike Protein Affinity Ligand ELisa Kit
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.
- Exact matched NGL COVID-19 Spike Protein Affinity Ligand standard
- Sensitivity of 0.2 ng/mL or 1.6 ppm
- Recovery: 80-120%
- Accuracy and Precision: inter-assay +/- 10%, Intra-assay +/- 15%
Kit Contents:
- Anti-protein A coated 96-well microtiter plate
- Reagent A: sample diluent (5X)
- Reagent B: NGL COVID-19 Spike Protein Affinity Ligand standard
- Reagent C: rabbit anti-Protein A: biotin probe
- Reagent D: streptavidin: peroxidase conjugate
- Reagent E: TMB peroxidase substrate
- PBS packs (quantity 2)
LONG®R3 IGF-I ELISA Kit
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
- Limited reactivity to native or recombinant IGF-1
- No reactivity to insulin
- Ready-to-use ELISA plate allows the assay to be run immediately without additional plate coating and blocking steps
Kit Contents:
- LONG®R3 IGF-I coated strip plate, 96 wells
- LONG®R3 IGF-I Standard
- Diluent
- Biotinylated detection antibody
- Streptavidin Peroxidase
- TMB Peroxidase Substrate
- LoBind® 1.5 mL Eppendorf tubes
NGL-IMPACT® A HipH LIGAND ELISA KIT
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.
- Exact matched Protein A reference standard (NGL-Impact® A HipH Ligand)
- Sensitivity of 0.1 ng/mL
- Recovery: 80-120%
- Accuracy & Precision: Inter-assay +/- 10%, Intra-assay +/- 15%
Kit Contents:
- Anti-protein A coated 96 well microtiter plate
- Reagent A: sample diluent (5x)
- Reagent B: NGL-Impact® A HipH Ligand standard
- Reagent C: rabbit anti-protein A: biotin probe
- Reagent D: streptavidin: peroxidase conjugate
- Reagent E: TMB peroxidase substrate
- PBS packs (quantity 2)
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.
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 commercial/clinical stage monoclonal antibodies and Fc Fusion protein therapeutics.
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 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.
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
* 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.