| Field | Specification |
|---|---|
| Target | |
| Alternative names | PF-00547659, PF-547659, SHP647 |
| UniProt # | |
| CAS no. | |
| Reactivity | |
| Applications | |
| Assay type | |
| Sample type(s) | Plasma, Serum |
| Sensitivity | |
| Detection range | |
| Detection method | |
| Storage | |
| Shipping | |
| Catalog no. (Mfr.) | |
| Main SKU |
Assay Principle
Ontamalimab ELISA Kit provides plate-based quantitative measurement of Ontamalimab. Each run carries its own standard series, so results remain comparable across plates, days, and operators in a research workflow.
Background
Ontamalimab (SHP647) is a fully human, immunoglobulin G2 , antihuman mucosal addressin cell adhesion molecule-1 (MAdCAM-1) monoclonal antibody being developed for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). A population pharmacokinetic/pharmacodynamic (PK/PD) analysis was conducted using clinical phase 2 study data to evaluate the PK and PD of ontamalimab following subcutaneous administrations of 7.5, 22.5, 75, and 225 mg every 4 weeks in patients with moderate to severe UC or CD. A total of 440 patients with UC (n = 249; 56.6%) or CD (n = 191; 43.4%) were included in the analysis. A 2-compartment model with parallel linear and nonlinear elimination adequately characterized concentration-time profiles of ontamalimab. The apparent clearance and volume of distribution were 0.0127 L/h (0.305 L/day) and 6.53 L, respectively. Apparent clearance and volume of distribution were mainly dependent on baseline albumin and body weight, respectively. No differences in the PK properties of ontamalimab were observed between patients with UC or CD. The presence of antidrug antibodies did not impact the PK of ontamalimab. Nonlinear elimination occurred at very low concentrations and was unlikely to contribute to the elimination half-life under steady-state conditions. A linear PK/PD model described the relationship between ontamalimab and free MAdCAM-1. Minimum concentrations of ontamalimab at steady state following 75 mg every 4 weeks were associated with >95% suppression of circulating free MAdCAM-1. The PK/PD properties characterized support phase 3 testing in UC and CD.
Specifications
| Assay Type | Quantitative Colorimetric ELISA |
|---|---|
| Detection Method | Colorimetric |
| Plate Format | 96-well (96T) |
| Sample Types | Plasma, Serum |
| Sensitivity | 0.156 μg/mL |
| Detection Range | 0.31-5 μg/mL |
| Recovery | 80-120% |
| Stability & Storage | The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% prior to the expiration date under appropriate storage condition. |
| Shipping | 2-8 °C |
| CAS Number | 2098790-40-8 |
| UniProt | Q13477 |
| Alternative Names | PF-00547659, PF-547659, SHP647 |
Performance Data
The kit provides a quantitative range of 0.31-5 μg/mL, an analytical sensitivity of 0.156 μg/mL, typical spike recovery of 80-120%. Plan sample dilutions so readouts fall within the linear portion of the standard curve, and evaluate matrix effects with dilution-linearity and spike-recovery controls.
Target Notes
The target is also referenced in the literature as PF-00547659, PF-547659, SHP647. Curated target information is available under UniProt accession Q13477. The corresponding compound is registered under CAS 2098790-40-8.
Common Research Applications
- Pharmacokinetic profiling of the drug in preclinical and translational research models
- Bioanalytical method development, bridging, and comparability studies
- Stability and formulation studies requiring reproducible concentration readouts
Safety & Handling
For Research Use Only. Not for diagnostic or therapeutic use. Handle all reagents and samples according to your institution's laboratory safety guidelines, and store components as recommended to preserve assay performance.
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