Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies.
作者： Michael Moxness , Suzanna Tatarewicz , Dohan Weeraratne , Nancy Murakami , Danika Wullner
DOI: 10.1373/CLINCHEM.2005.053272
关键词:
摘要: Monitoring the immune response against human therapeutic monoclonal antibodies is an important component of preclinical and clinical trials to assess drug exposure, efficacy, safety (1)(2). Detection (analyte) directed (drug) difficult because similarity structure between analyte high concentrations present in serum, particularly during toxicology studies (3)(4). The purpose this study was develop a robust assay format applicable across species compounds for rapid method development validation. We developed 5 assays detect distinct antibody products. dependent on bivalent binding both biotin- ruthenium-conjugated (for schematic assay, see Fig. 1 Data Supplement that accompanies online version abstract at http://www.clinchem.org/content/vol51/issue10/). This “bridging” eliminated need species–specific secondary provided consistency different serum matrices as product moves from development. …
oup.com
aaccjnls.org参考文章(6)
M Wadhwa, C Bird, P Dilger, R Gaines-Das, R Thorpe, Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals. Journal of Immunological Methods. ,vol. 278, pp. 1- 17 ,(2003) , 10.1016/S0022-1759(03)00206-0
Ole Henrik Brekke, Inger Sandlie, Therapeutic antibodies for human diseases at the dawn of the twenty-first century Nature Reviews Drug Discovery. ,vol. 2, pp. 52- 62 ,(2003) , 10.1038/NRD984
Anthony R Mire-Sluis, Yu Chen Barrett, Viswanath Devanarayan, Eugen Koren, Hank Liu, Mauricio Maia, Thomas Parish, George Scott, Gopi Shankar, Elizabeth Shores, Steven J Swanson, Gary Taniguchi, Daniel Wierda, Linda A Zuckerman, Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products Journal of Immunological Methods. ,vol. 289, pp. 1- 16 ,(2004) , 10.1016/J.JIM.2004.06.002
MICHAEL MOXNESS, JIM FOLEY, MARK STENE, DEBORAH FINCO-KENT, VAHE BEDIAN, ALAN KRASNER, THOMAS KAWABATA, Development and Validation of Radioligand Binding Assays to Measure Total, IgA, IgE, IgG, and IgM Insulin Antibodies in Human Serum Annals of the New York Academy of Sciences. ,vol. 1005, pp. 265- 268 ,(2003) , 10.1196/ANNALS.1288.040
Kristian Linnet, Marina Kondratovich, Partly Nonparametric Approach for Determining the Limit of Detection Clinical Chemistry. ,vol. 50, pp. 732- 740 ,(2004) , 10.1373/CLINCHEM.2003.029983
H. Schellekens, Immunogenicity of therapeutic proteins Nephrology Dialysis Transplantation. ,vol. 18, pp. 1257- 1259 ,(2003) , 10.1093/NDT/GFG164