Interference in immunoassays to support therapeutic antibody development in preclinical and clinical studies.
作者： Martin Schwickart , Inna Vainshtein , Rozanne Lee , Amy Schneider , Meina Liang
DOI: 10.4155/BIO.14.127
关键词: Protein biomarkers 、 Complex matrix 、 Computational biology 、 Pharmacology 、 Drug development 、 Therapeutic antibody 、 Mechanism (biology) 、 Target engagement 、 Dose selection 、 Chemistry
摘要: During preclinical and clinical studies, immunoassays are used to measure the concentration of therapeutic antibody, anti-drug antibodies soluble protein biomarkers. The reliability these assays is crucial since results routinely for safety assessment dose selection. Furthermore, biomarkers can provide information about target engagement, proof mechanism, principle prediction response. Study samples mostly consist complex matrices that exhibit considerable interference, resulting in inaccurate measurements. This perspective discusses source interference strategies mitigate or eliminate during drug development drugs with a focus on antibodies.
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sci-hub.se 参考文章(65)
L T Williams, H N Antoniades, Human platelet-derived growth factor: structure and function. Federation proceedings. ,vol. 42, pp. 2630- 2634 ,(1983)
T H Weber, P Tanner, K I Käpyaho, Endogenous interference in immunoassays in clinical chemistry. A review. Scandinavian Journal of Clinical & Laboratory Investigation. ,vol. 201, pp. 77- 82 ,(1990)
James A. Lofgren, Sripriya Dhandapani, Jason J. Pennucci, Christina M. Abbott, Daniel T. Mytych, Arunan Kaliyaperumal, Steven J. Swanson, Michael C. Mullenix, Comparing ELISA and Surface Plasmon Resonance for Assessing Clinical Immunogenicity of Panitumumab Journal of Immunology. ,vol. 178, pp. 7467- 7472 ,(2007) , 10.4049/JIMMUNOL.178.11.7467
Thomas Dörner, Arne Hansen, Autoantibodies in normals – the value of predicting rheumatoid arthritis Arthritis Research & Therapy. ,vol. 6, pp. 282- 284 ,(2004) , 10.1186/AR1456
D Ritter, R Stott, N Grant, M H Nahm, Endogenous antibodies that interfere with thyroxine fluorescence polarization assay but not with radioimmunoassay or EMIT. Clinical Chemistry. ,vol. 39, pp. 508- 511 ,(1993) , 10.1093/CLINCHEM/39.3.508
Larry J Kricka, Human Anti-Animal Antibody Interferences in Immunological Assays Clinical Chemistry. ,vol. 45, pp. 942- 956 ,(1999) , 10.1093/CLINCHEM/45.7.942
James Araujo, Marcel Zocher, Kristin Wallace, Kun Peng, Saloumeh Kadkhodayan Fischer, Increased rheumatoid factor interference observed during immunogenicity assessment of an Fc-engineered therapeutic antibody Journal of Pharmaceutical and Biomedical Analysis. ,vol. 55, pp. 1041- 1049 ,(2011) , 10.1016/J.JPBA.2011.03.008
Gopi Shankar, Viswanath Devanarayan, Lakshmi Amaravadi, Yu Chen Barrett, Ronald Bowsher, Deborah Finco-Kent, Michele Fiscella, Boris Gorovits, Susan Kirschner, Michael Moxness, Thomas Parish, Valerie Quarmby, Holly Smith, Wendell Smith, Linda A. Zuckerman, Eugen Koren, Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products Journal of Pharmaceutical and Biomedical Analysis. ,vol. 48, pp. 1267- 1281 ,(2008) , 10.1016/J.JPBA.2008.09.020
Mark Boterman, Mira Doig, Massimo Breda, Steve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Isabelle Dumont, Suzanne Martinez, Shane Needham, Maria Cruz Caturla, Philippe Couerbe, Joelle Guittard, John Maltas, Tim Lansing, Masood Bhatti, Christine Schiebl, Petra Struwe, Curtis Sheldon, Roger Hayes, Timothy Sangster, Colin Pattison, Johanne Bouchard, Lee Goodwin, Rafiq Islam, Rudi Segers, Zhongping (John) Lin, Jim Hillier, Wei Garofolo, Dieter Zimmer, Lois Folguera, Thomas Zimmermann, Maria Pawula, Marc Moussallie, Leonardo de Souza Teixeira, Thais Rocha, Daniel Tang, Paula Jardieu, James Truog, Jenny Lin, Richard Lundberg, Chris Cox, Alan Breau, Chiara Bigogno, Dick Schoutsen, Carmen Dilger, Mohammed Bouhajib, Ann Levesque, Sofi Gagnon-Carignan, Robert Nicholson, Rand Jenkins, Ming Hung Lin, Shane Karnik, Theo De Boer, Richard Houghton, Rachel Green, William DeMaio, Romuald Sable, Kirk Smith, Christoph Siethoff, Laura Cojocaru, Mike Allen, Tammy Harter, Saadya Fatmi, Farhad Sayyarpour, Michele Malone, Stuart Best, Xinping Fang, Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC) Bioanalysis. ,vol. 4, pp. 651- 660 ,(2012) , 10.4155/BIO.12.18
R. Aleks Davis, Anthony M. Butterfield, Robert J. Konrad, James S. Bourdage, A novel method for quantitative measurement of a biomarker in the presence of a therapeutic monoclonal antibody directed against the biomarker Journal of Pharmaceutical and Biomedical Analysis. ,vol. 48, pp. 897- 901 ,(2008) , 10.1016/J.JPBA.2008.07.012