Catalog No.

KDG54901

Stability and 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.

Detection method

Colorimetric

Precision

CV<20%

Sample type

Plasma, Serum

Assay type

Quantitative

Sensitivity

0.156 μg/ml

Range

0.31-5 μg/mL

Recovery

80-120%

Specifications

Ontamalimab

Alternative Names

PF-00547659, PF-547659, SHP647, CAS: 2098790-40-8

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.

Shipping

2-8 ℃

Note

For Research Use Only.

Aiming to develop the most reliable bioreagents, AntibodySystem SAS was founded in 2019 in France by a team of professionals from top industrial companies and research institutes. The collective scientific and technical experiences in our team have brought breaking throughs in multiple product developments, including recombinant antibodies, recombinant proteins, biosimilar, RUO ELISA kits and other related products. By working with talented researchers and technicians, AntibodySystem continues to upgrade product qualities and lower the overall cost, offering accountable and affordable solutions for biolabs all over the world. Since its establishment, AntibodySystem has built long term and stable collaborations with academia, pharmaceutical industry, biotech companies and research hospitals, supporting their R&D by AntibodySystem's bioreagents with excellent data accuracy and reproducibility.

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