{"title":"使用Melon™凝胶和SPEAD预处理开发和验证TRK-950抗药抗体测定。","authors":"Reiji Nishio, Keita Nakanaga, Ryosuke Yoshinaga, Akira Kurihara, Fumiyoshi Okano","doi":"10.1080/17576180.2025.2493607","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim & methods: </strong>TRK-950, a humanized IgG1 monoclonal antibody against CAPRIN-1, which is reported to be expressed on the cell surface of various forms of cancer, is currently being developed for multiple types of solid cancer. We developed an antidrug antibody (ADA) assay that includes two pretreatment processes for use in clinical trials, namely, Melon™ gel treatment and solid-phase extraction with acid dissociation (SPEAD), to reduce baseline variability between individual serum samples and improve drug tolerance.</p><p><strong>Results: </strong>Comparing the assay with or without the pretreatment process using commercially available human serum samples, the mean response calculated from 18 individual human samples decreased from 327 to 270, and the coefficient of variation decreased from 41% to 16%. The new assay with the two-step pretreatment met the criteria set by the regulatory agency throughout the validation study. We also confirmed the recovery rates of IgG, IgM, and ADA - drug immune complexes after treatment with Melon™ gel. Clinical trials (NCT05423262) employing this improved analytical method have been conducted, and the results confirm the low immunogenicity of TRK-950.</p><p><strong>Conclusion: </strong>The combination of pretreatment with Melon™ gel and SPEAD is applicable for clinical ADA assays.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"515-524"},"PeriodicalIF":1.8000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087920/pdf/","citationCount":"0","resultStr":"{\"title\":\"Development and validation of an antidrug antibody assay for TRK-950 using Melon™ gel and SPEAD pretreatment.\",\"authors\":\"Reiji Nishio, Keita Nakanaga, Ryosuke Yoshinaga, Akira Kurihara, Fumiyoshi Okano\",\"doi\":\"10.1080/17576180.2025.2493607\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim & methods: </strong>TRK-950, a humanized IgG1 monoclonal antibody against CAPRIN-1, which is reported to be expressed on the cell surface of various forms of cancer, is currently being developed for multiple types of solid cancer. We developed an antidrug antibody (ADA) assay that includes two pretreatment processes for use in clinical trials, namely, Melon™ gel treatment and solid-phase extraction with acid dissociation (SPEAD), to reduce baseline variability between individual serum samples and improve drug tolerance.</p><p><strong>Results: </strong>Comparing the assay with or without the pretreatment process using commercially available human serum samples, the mean response calculated from 18 individual human samples decreased from 327 to 270, and the coefficient of variation decreased from 41% to 16%. The new assay with the two-step pretreatment met the criteria set by the regulatory agency throughout the validation study. We also confirmed the recovery rates of IgG, IgM, and ADA - drug immune complexes after treatment with Melon™ gel. Clinical trials (NCT05423262) employing this improved analytical method have been conducted, and the results confirm the low immunogenicity of TRK-950.</p><p><strong>Conclusion: </strong>The combination of pretreatment with Melon™ gel and SPEAD is applicable for clinical ADA assays.</p>\",\"PeriodicalId\":8797,\"journal\":{\"name\":\"Bioanalysis\",\"volume\":\" \",\"pages\":\"515-524\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087920/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bioanalysis\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/17576180.2025.2493607\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/4/17 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"BIOCHEMICAL RESEARCH METHODS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bioanalysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17576180.2025.2493607","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/17 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
Development and validation of an antidrug antibody assay for TRK-950 using Melon™ gel and SPEAD pretreatment.
Aim & methods: TRK-950, a humanized IgG1 monoclonal antibody against CAPRIN-1, which is reported to be expressed on the cell surface of various forms of cancer, is currently being developed for multiple types of solid cancer. We developed an antidrug antibody (ADA) assay that includes two pretreatment processes for use in clinical trials, namely, Melon™ gel treatment and solid-phase extraction with acid dissociation (SPEAD), to reduce baseline variability between individual serum samples and improve drug tolerance.
Results: Comparing the assay with or without the pretreatment process using commercially available human serum samples, the mean response calculated from 18 individual human samples decreased from 327 to 270, and the coefficient of variation decreased from 41% to 16%. The new assay with the two-step pretreatment met the criteria set by the regulatory agency throughout the validation study. We also confirmed the recovery rates of IgG, IgM, and ADA - drug immune complexes after treatment with Melon™ gel. Clinical trials (NCT05423262) employing this improved analytical method have been conducted, and the results confirm the low immunogenicity of TRK-950.
Conclusion: The combination of pretreatment with Melon™ gel and SPEAD is applicable for clinical ADA assays.
BioanalysisBIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL
CiteScore
3.30
自引率
16.70%
发文量
88
审稿时长
2 months
期刊介绍：
Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing.
The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality.
Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing.
The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques.
Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.
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