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Development and validation of an enzyme-linked immunosorbent assay to measure free eculizumab concentration in serum.
- Source :
-
Bioanalysis [Bioanalysis] 2017 Aug; Vol. 9 (16), pp. 1227-1235. Date of Electronic Publication: 2017 Aug 02. - Publication Year :
- 2017
-
Abstract
- Aim: Eculizumab is a monoclonal antibody toward C5 fraction of the complement system. It is approved to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. To perform pharmacokinetic studies and therapeutic drug monitoring, a validated assay is required.<br />Materials & Methods: An indirect ELISA with recombinant human C5 sensitized microtiter plates were developed.<br />Results: The assay allows the measurement of free eculizumab concentration in human serum. The LOD, LLOQ and ULOQ were 0.091, 0.25 and 82.35 mg/l, respectively. The assay meets EMA and US FDA guidelines criteria for the validation of a ligand-binding assay.<br />Conclusion: This method is validated and can be used in PK and PK-PD studies as well as to perform therapeutic drug monitoring of free eculizumab.
- Subjects :
- Adult
Aged
Antibodies, Monoclonal, Humanized immunology
Antibodies, Monoclonal, Humanized pharmacokinetics
Complement System Proteins immunology
Drug Monitoring
Female
Humans
Limit of Detection
Male
Middle Aged
Tissue Distribution
Antibodies, Monoclonal, Humanized blood
Blood Chemical Analysis methods
Enzyme-Linked Immunosorbent Assay methods
Subjects
Details
- Language :
- English
- ISSN :
- 1757-6199
- Volume :
- 9
- Issue :
- 16
- Database :
- MEDLINE
- Journal :
- Bioanalysis
- Publication Type :
- Academic Journal
- Accession number :
- 28766381
- Full Text :
- https://doi.org/10.4155/bio-2017-0070