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Bioanalysis. 2015;7(10):1253-60. doi: 10.4155/bio.15.30.

Development and validation of an enzyme-linked immunosorbent assay to measure adalimumab concentration.

Author information

1
1Université François Rabelais de Tours, CNRS UMR 7292, Tours, France.
2
2CHRU de Tours, Laboratory of Pharmacology-Toxicology, Tours, France.
3
4Clinical Immunology, GlaxoSmithKline, Upper Merion, 709 Swedeland Road, Kings of Prussia, PA 19406, USA.
4
3CHRU de Tours, Department of Rheumatology, Tours, France.

Abstract

BACKGROUND:

Adalimumab is a therapeutic antibody used for treating inflammatory diseases. To understand interindividual PK variability, there is a need to develop and validate an assay to measure serum adalimumab concentrations.

METHODS:

An ELISA was developed on microtiter plates coated with TNF-α. Seven nonzero adalimumab standards ranging from 0.05 to 50 mg/l and three quality controls (0.2, 2.5 and 7 mg/l) were tested for their intra and interday precision on six occasions.

RESULTS:

The LOD, LLOQ and ULOQ of the assay were 0.022, 0.073 and 9 mg/l, respectively.

CONCLUSION:

This method is accurate, reproducible and may be useful for PK studies and for therapeutic drug monitoring of adalimumab.

PMID:
26045004
DOI:
10.4155/bio.15.30
[Indexed for MEDLINE]

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