The PrismA ELISA™ kit is an enzyme-linked immunosorbent assay designed to measure residual ligand leakage when using MabSelect PrismA™ chromatography resin and Fibro™ PrismA chromatography adsorbers. The kit is used during the development and manufacture of monoclonal antibody (mAb) biopharmaceuticals.
The PrismA ELISA™ kit contains all reagents required to perform the assay. This includes the PrismA ligand optimized for use in ELISA and polyclonal antibodies raised specifically against the PrismA ligand. The PrismA ELISA™ kit was developed with a focus on usability, robustness, and environmental sustainability.
Downstream samples generally have high concentrations of IgG, which creates a challenge for protein A measurement. Accurate measurement requires dissociation of the ligand and IgG, which is especially tricky when the concentration of protein A ligand is very low (< 1 ppm) due to the large excess of IgG.
To determine the effect of IgG on dissociation, we spiked high, medium, and low concentrations of PrismA ligand into decreasing concentrations of IgG. The PrismA ELISA™ kit could accurately determine PrismA concentration in samples containing as high as 20 mg/mL of IgG.
The PrismA ELISA™ kit delivers high sensitivity for detecting trace amounts of ligand—even during the final stages of purification:
View data file to see supporting data for these performance specifications.
The PrismA ELISA™ kit delivers accurate and reproducible results over multiple experiments, and has been tested with common buffers used in downstream purification of monoclonal antibodies. The results showed the kit was compatible with all five buffers tested, as indicated by all dilutions of each sample (8/8) being within the acceptance criteria of the assay, and the parallelism being below the target of 20%.
Contents of the PrismA ELISA™ kit include:
| Component | Volume |
|---|---|
| PrismA ELISA™ Kit Assay Buffer (1X) | 10 mL |
| PrismA ELISA™ Kit Detection Antibody Diluent (1X) | 15 mL |
| PrismA ELISA™ Kit Wash Buffer (10X) | 25 mL |
| PrismA ELISA™ Kit TMB (1X) | 15 mL |
| PrismA ELISA™ Kit Dissociation Buffer (1X) | 30 mL |
| PrismA ELISA™ Kit Stop Buffer (1X) | 15 mL |
| PrismA ELISA™ Kit Standard | 1 vial |
| PrismA ELISA™ Kit Detection Antibody | 140 µL |
| PrismA ELISA™ Kit 96 Well Strip-Plate | 1 plate |
| PrismA ELISA™ Kit Plate Seal | 1 seal |
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