Application of an electrochemiluminescence assay for quantification of E6011, an antifractalkine monoclonal antibody, to pharmacokinetic studies in monkeys and humans.

ABSTRACT:

Background

E6011, a humanized antifractalkine monoclonal antibody, is under development for the treatment of various inflammatory diseases, such as rheumatoid arthritis. A reproducible assay method has been developed for the determination of E6011 in monkey and human serum by electrochemiluminescence (ECL) assay.

Methods

E6011 in serum was captured by fractalkine and detected by ruthenium-labeled rabbit anti-E6011 Fab polyclonal antibodies for ECL detection. E6011 in serum was quantifiable from 0.02 and 0.1 μg/mL in monkey and human serum, respectively, with minimum required dilution of 500. The method was then validated in accordance with bioanalytical guidelines.

Results

Accuracy and precision of quality control samples at five concentrations in intra- and interbatc

SUBMITTER: Aoyama M 

PROVIDER: S-EPMC6430341 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature