The VH3 ligand ELISA kit contains all the reagents required to perform the assay, including the VH3 ligand optimized for use in ELISA. The VH3 ligand ELISA kit was developed with a focus on usability, robustness, and environmental sustainability. VH3 ligand ELISA kits are specifically designed for use with MabSelect™ VH3 chromatography resins .
Accelerate process development with matched ligand leakage ELISA kits
High drug product tolerance
Downstream samples generally have high concentrations of drug substance. This creates a challenge for protein A measurement. Accurate measurement requires dissociation of the ligand and drug substance, which is especially tricky when the concentration of protein A ligand is very low (< 1 ppm) due to the large excess of drug substance.
To determine the effect of IgG on dissociation, we spiked high, medium, and low concentrations of VH3 ligand into decreasing concentrations of IgG. The VH3 ligand ELISA kit could accurately determine VH3 concentration in samples containing as high as 30 mg/mL of IgG in the sample.
Avoid unexpected leached VH3 ligand levels in later development
The VH3 ligand ELISA kit is capable of detecting low amounts of ligand, including at the final stages of purification. Leached protein A concentration in downstream materials is usually very low. Therefore, a highly sensitive assay is required to measure leached ligand in these types of samples. The VH3 ligand ELISA kit has a lower limit of detection (LLD) of 10 pg/mL and a lower limit of quantification (LLQ) of 10 pg/mL.
A robust and reproducible assay
It is important to have an assay that can give accurate and reproducible results over multiple experiments. Assay precision is the coefficient of variation (CV) within a single assay (intra-assay) and across several experiments (inter-assay).
Intra-assay variation was assessed from the interpolated concentration of 155 in-process sample measurements. 89% of samples had an intra-assay CV <5%, with a mean CV of 2.10%.
Inter-assay precision was assessed from spiked samples containing 2500, 1000, 500, or 50 pg/mL VH3, with and without IgG. The average recovery of these samples was 96.80%, with a mean CV of 8.28%.
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