Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

Journal of Pharmacological and Toxicological Methods

Volumn 63, Issue 3, 2011, Pages 227-235

  Roman, Jeanette ^a   Qiu, Julia ^a   Dornadula, Geethanjali ^a   Hamuro, Lora ^a   Bakhtiar, Ray ^a   Verch, Thorsten ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Bioanalysis; Gyrolab; Methods; Microfluidics; Miniaturized immunoassay; Pharmacokinetic

Indexed keywords

IMMUNOGLOBULIN G;

ACCURACY; ARTICLE; AUTOANALYZER; CONTROLLED STUDY; COST BENEFIT ANALYSIS; ENZYME LINKED IMMUNOSORBENT ASSAY; EVALUATION RESEARCH; IMMUNOASSAY; INTERMETHOD COMPARISON; MICROFLUIDIC ANALYSIS; MICROTITER PLATE ASSAY; MOUSE; NONHUMAN; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; RAT; SENSITIVITY AND SPECIFICITY; SPECIES DIFFERENCE; TRANSGENIC MOUSE; VALIDATION PROCESS;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOPHARMACEUTICS; DRUG EVALUATION, PRECLINICAL; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOASSAY; MACACA FASCICULARIS; MACACA MULATTA; MICE; MICE, TRANSGENIC; MINIATURIZATION; PHARMACOKINETICS; RATS; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; TUMOR NECROSIS FACTOR-ALPHA;

ANIMALIA; MUS MUSCULUS;

EID: 79954603778     PISSN: 10568719     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vascn.2010.12.002     Document Type: Article

References (18)

1. David Wild The immunoassay handbook 3rd 2005, Elsevier Science, London, UK.
2. Ellington A.A., Kullo I.J., Bailey K.R., Klee G.G. Antibody-based protein multiplex platforms: Technical and operational challenges. Clinical Chemistry 2010, 56:186-193.
3. Eriksson C., Agaton C., Kange R., Sundberg M., Nilsson P., Ek B., Uhlen M., Gustafsson M., Hober S. Microfluidic analysis of antibody specificity in a compact disk format. Journal of Proteome Research 2006, 5:1568-1574.
4. Ezan Eric, Bitsch Francis Critical comparison of MS and immnoassay for the bioanalysis of therapeutic antibodies. Bioanalysis 2009, 1:1375-1388.
5. Ezan E., Dubois M., Becher F. Bioanalysis of recombinant proteins and antibodies by mass spectrometry. The Analyst 2009, 134:825-834.
6. Hamuro L.L., Qiu J., Verch T., Song L., Liao J., Fernandez-Metzler C. Miniaturized and automated immunoassays using a Gyrolab Bioaffy CD workstation for PK support of protein biologics. 16th North American Regional ISSX Meeting, Baltimore, MD, USA 2009.
7. Jokerst J.V., Raamanathan A., Christodoulides N., Floriano P.N., Pollard A.A., Simmons G.W., Wong J., Gage C., Furmaga W.B., Redding S.W., McDevitt J.T. Nano-bio-chips for high performance multiplexed protein detection: Determinations of cancer biomarkers in serum and saliva using quantum dot bioconjugate labels. Biosensors Bioelectronics 2009, 24:3622-3629.
8. Kange R., Selditz U., Granberg M., Lindberg U., Ekstrand G., Ek B., Gustafsson M. Comparison of different IMAC techniques used for enrichment of phosphorylated peptides. Journal of Biomolecular Techniques 2005, 16:91-103.
9. Lund T., Mangsbo S.M., Scholz H., Gjorstrup P., Totterman T.H., Korsgren O., Foss A. Resolvin E1 reduces proinflammatory markers in human pancreatic islets in vitro. Experimental and Clinical Endocrinology Diabetes 2010, 118:237-244.
10. Mora Johanna R., Obenauer-Kutner Linda, Vimal Patel Vimal application of the Gyrolab platform to ligand-binding assays: A user's perspective. Bioanalysis 2010, 2:1711-1715.
11. Ray C.A., Zhou L., Tsoi J., Uy L., Gu J., Malella J., Desimone D., Gunn H., Ma M., Lee J., Desilva B. A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins. Journal of Pharmaceutical and Biomedical Analysis 2010, 53:729-734.
12. Rivera E., Ekholm PetterssonF., Inganas M., Paulie S., Gronvik K.O. The Rb1 fraction of ginseng elicits a balanced Th1 and Th2 immune response. Vaccine 2005, 23:5411-5419.
13. Singh D., Kane B., Molfino N.A., Faggioni R., Roskos L., Woodcock A. A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma. BMC Pulmonary Medicine 2010, 10:3.
14. Stubenrauch K., Wessels U., Lenz H. Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates. Journal of Pharmaceutical and Biomedical Analysis 2009, 49:1003-1008.
15. Templin M.F., Stoll D., Bachmann J., Joos T.O. Protein microarrays and multiplexed sandwich immunoassays: What beats the beads?. Combinatorial Chemistry & High Throughput Screening 2004, 7:223-229.
16. van der Woude C.J., Stokkers P., van Bodegraven A.A., Van Assche G., Hebzda Z., Paradowski L., D'Haens G., Ghosh S., Feagan B., Rutgeerts P., Dijkstra G., de Jong D.J., Oldenburg B., Farhan M., Richard T., Dean Y., Hommes D.W. Phase I, double-blind, randomized, placebo-controlled, dose-escalation study of NI-0401 (a fully human anti-CD3 monoclonal antibody) in patients with moderate to severe active Crohn's disease. Inflammatory Bowel Diseases 2010, 16:1708-1716.
17. Yang J., Ng C., Lowman H., Chestnut R., Schofield C., Sandlund B., Ernst J., Bennett G., Quarmby V. Quantitative determination of humanized monoclonal antibody rhuMAb2H7 in cynomolgus monkey serum using a Generic Immunoglobulin Pharmacokinetic (GRIP) assay. Journal of Immunological Methods 2008, 335:8-20.
18. Yeung D., Stevenson L.F., Osterlund K., Amaravadi L. Development of a pharmacokinetic assay for biotherapeutic X in human serum: Comparison of ELISA, fluorometric and electrochemiluminescent assay platforms 2008, American Association of Pharmaceutical Scientists, Toronto, Canada.