{"title":"免疫捕获-液相色谱/质谱法抗药物抗体分析现状","authors":"Lin-Zhi Chen","doi":"10.17145/JAB.18.011","DOIUrl":null,"url":null,"abstract":"During drug development, anti-drug antibodies (ADA) is closely monitored for immunogenicity assessment. Ligand binding assay is currently the most widely used platform for ADA detection. Very recently, immunocapture-LC/MS was developed for ADA analysis including isotyping and semi-quantitation. This mini-review summarizes literatures pertaining to immunocapture-LC/MS ADA analysis with focus on methodology, applications and regulatory aspects. Current thinking and considerations as well as outlook are also presented.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"4 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2018-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"5","resultStr":"{\"title\":\"Current Status of Anti-Drug Antibody Analysis Using Immunocapture-Liquid Chromatography/Mass Spectrometry\",\"authors\":\"Lin-Zhi Chen\",\"doi\":\"10.17145/JAB.18.011\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"During drug development, anti-drug antibodies (ADA) is closely monitored for immunogenicity assessment. Ligand binding assay is currently the most widely used platform for ADA detection. Very recently, immunocapture-LC/MS was developed for ADA analysis including isotyping and semi-quantitation. This mini-review summarizes literatures pertaining to immunocapture-LC/MS ADA analysis with focus on methodology, applications and regulatory aspects. Current thinking and considerations as well as outlook are also presented.\",\"PeriodicalId\":15014,\"journal\":{\"name\":\"Journal of Applied Bioanalysis\",\"volume\":\"4 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2018-07-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"5\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Applied Bioanalysis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17145/JAB.18.011\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Applied Bioanalysis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17145/JAB.18.011","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Current Status of Anti-Drug Antibody Analysis Using Immunocapture-Liquid Chromatography/Mass Spectrometry
During drug development, anti-drug antibodies (ADA) is closely monitored for immunogenicity assessment. Ligand binding assay is currently the most widely used platform for ADA detection. Very recently, immunocapture-LC/MS was developed for ADA analysis including isotyping and semi-quantitation. This mini-review summarizes literatures pertaining to immunocapture-LC/MS ADA analysis with focus on methodology, applications and regulatory aspects. Current thinking and considerations as well as outlook are also presented.