Bioanalysis最新文献_第4页

Simultaneous isotyping and semi-quantitation of anti-drug antibodies to an IgG1 biotherapeutic using hybrid LBA-LC-MS/MS. 使用混合LBA-LC-MS/MS同时进行IgG1生物治疗药物抗药抗体的同型和半定量

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2024-12-18 DOI: 10.1080/17576180.2024.2441058

Frank B Schalk, Davide Guerrieri, Johann Poetzl, Nico C van de Merbel

{"title":"Simultaneous isotyping and semi-quantitation of anti-drug antibodies to an IgG1 biotherapeutic using hybrid LBA-LC-MS/MS.","authors":"Frank B Schalk, Davide Guerrieri, Johann Poetzl, Nico C van de Merbel","doi":"10.1080/17576180.2024.2441058","DOIUrl":"10.1080/17576180.2024.2441058","url":null,"abstract":"Background: Commonly, ligand-binding platforms are being used for immunogenicity assessment, but with the recent advent of liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) for protein quantification, this technology has become an alternative for the measurement of anti-drug antibodies (ADAs), when combined with an immunocapture step to extract them out of the biological sample.Method: The monoclonal antibody adalimumab was immobilized on magnetic beads to isolate ADAs against this drug from serum samples. Multiple repetitions of immunopurification were used to minimize nonspecific binding and improve drug tolerance while maintaining sufficient recovery. A subsequent tryptic digestion released peptides, from which unique peptide sequences, originating from the constant region of seven ADA subclasses, were selected. These were then analyzed by LC-MS/MS against (unextracted) subclass-specific reference standards for semi-quantification.Results: With two immunocapture and two immunopurification steps, the method simultaneously measures the ADA subclasses IgG1, IgG2, IgG3, IgG4, IgM, IgE and IgA within their relevant ranges, with good repeatability and drug tolerance, and limited interference of endogenous immunoglobulins. The method was successfully applied for the analysis of serum samples of subjects dosed with adalimumab.Conclusion: Hybrid LBA-LC-MS/MS is a viable platform for measuring ADAs and adds value, especially when ADA isotyping is needed.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"87-98"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801339/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development and validation of an ultrasensitive qPCR method to identify and quantify EGFR T790M in cell-free DNA. 建立和验证一种超灵敏的qPCR方法来鉴定和定量游离DNA中的EGFR T790M。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2025-01-15 DOI: 10.1080/17576180.2025.2451527

Shenglei Yuan, Nan Jia, Guofu Lu, Jinping Lai, Wenzhong Liang, Lan Li, Chenpu Zhang, Jianbo Diao

引用次数: 0

Development of a validated novel bead extraction method for the detection of anti-PEG antibodies in human serum. 建立一种有效的新型蛋白头提取方法，用于检测人血清中的抗聚乙二醇抗体。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2024-12-18 DOI: 10.1080/17576180.2024.2442198

William T Williams, Kathryn Lindley, Hong Liao, Lynn Kamen, Michelle Miller, Amanda Hays, Jeffrey Sailstad

{"title":"Development of a validated novel bead extraction method for the detection of anti-PEG antibodies in human serum.","authors":"William T Williams, Kathryn Lindley, Hong Liao, Lynn Kamen, Michelle Miller, Amanda Hays, Jeffrey Sailstad","doi":"10.1080/17576180.2024.2442198","DOIUrl":"10.1080/17576180.2024.2442198","url":null,"abstract":"Aims: Polyethylene glycol (PEG) is used in many applications including drug development. Due to exposure to environmental products, there is a high prevalence of preexisting anti-PEG antibodies in the global human population. The presence of anti-PEG antibodies is a concern for potentially reducing the efficacy of therapeutics after administration and represents a risk of safety events after exposure to PEGylated drug products. We developed and validated a creative and sensitive method for the detection of anti-PEG antibodies in human serum to support clinical programs for PEGylated drugs.Methods: In this method, biotin-PEG streptavidin beads were used to extract anti-PEG antibodies from human serum for analysis in an anti-PEG ELISA assay. The same serum sample was analyzed in an anti-drug antibody assay.Results: The anti-PEG antibody assay was validated with a screening cut point of 1.41 normalized signal, confirmatory cut point of 32.2% inhibition, sensitivity of 7.81 ng/mL and sufficient reproducibility, selectivity, and drug tolerance in accordance with the FDA 2019 Immunogenicity guidance.Conclusion: This method of removal of anti-PEG antibodies enables the use of a single sample to detect anti-drug and anti-PEG antibodies to support drug development programs.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"7-15"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142852295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Back to nature: immunocapture and related methods for the selective analysis of pharmaceutical and biomedical samples. 回归自然：用于药物和生物医学样品选择性分析的免疫捕获和相关方法。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2024-12-04 DOI: 10.1080/17576180.2024.2437308

David S Hage

引用次数: 0

Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 1: "The What"). 透视研究和监管生物分析中用于生物治疗和生物标记蛋白质的液相色谱-质谱联用仪（/MS）：欧洲生物分析论坛社区十多年来的经验总结（第 1 部分："什么"）。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2024-11-06 DOI: 10.1080/17576180.2024.2418250

Amanda Wilson, Mark Jean Gnoth, Nico van de Merbel, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love, Stephane Muccio, Matthew Barfield, Rob Wheller, Philip Timmerman

{"title":"Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 1: \"The What\").","authors":"Amanda Wilson, Mark Jean Gnoth, Nico van de Merbel, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love, Stephane Muccio, Matthew Barfield, Rob Wheller, Philip Timmerman","doi":"10.1080/17576180.2024.2418250","DOIUrl":"10.1080/17576180.2024.2418250","url":null,"abstract":"Following up on our most recent discussion paper focusing on the continued regulatory challenges for bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS, the European Bioanalysis Forum reports back on their internal discussions on and experience with method development for biotherapeutic and biomarker proteins in research and regulated bioanalysis. Due to the broad array of topics discussed, this information is spread over two research papers, where one focusses on the fundamental principles on which the technology is built (i.e., the what?) and another on the practical considerations (i.e., the how). In this paper, we discuss 'the what'. Both papers should be helpful for the bioanalytical community to better understand the challenges and provide an insight on why bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS should not be compared with the more traditional LC-MS/MS assay for small molecules or ligand binding assays for biotherapeutics.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"63-70"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801335/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Cross-validation of pharmacokinetic assays post-ICH M10 is not a pass/fail criterion. ICH M10 后的药代动力学测定的交叉验证不是通过/失败标准。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2024-11-06 DOI: 10.1080/17576180.2024.2418284

Marianne Scheel Fjording, Joanne Goodman, Chad Briscoe

引用次数: 0

Two decades of immunocapture liquid chromatography tandem mass spectrometry for pharmaceutical discovery and development: reflections and recommendations for optimal deployment. 免疫捕获液相色谱串联质谱用于药物发现和开发二十年：反思与优化部署建议。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2024-10-28 DOI: 10.1080/17576180.2024.2415763

Bradley L Ackermann

引用次数: 0

A green bioanalytical spectrofluorimetric approach for estimation of Avapritinib anti-tumor drug; application to quality control and clinical studies. 绿色生物分析荧光法测定抗肿瘤药物阿伐替尼的含量应用于质量控制和临床研究。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2025-01-14 DOI: 10.1080/17576180.2025.2451518

Baher I Salman, Roshdy E Saraya, Yasser F Hassan, Ahmed I Hassan, Hany A Batakoushy, Mohamed A A Abdel-Aal, Ahmed Al-Harrasi, Adel Ehab Ibrahim

{"title":"A green bioanalytical spectrofluorimetric approach for estimation of Avapritinib anti-tumor drug; application to quality control and clinical studies.","authors":"Baher I Salman, Roshdy E Saraya, Yasser F Hassan, Ahmed I Hassan, Hany A Batakoushy, Mohamed A A Abdel-Aal, Ahmed Al-Harrasi, Adel Ehab Ibrahim","doi":"10.1080/17576180.2025.2451518","DOIUrl":"10.1080/17576180.2025.2451518","url":null,"abstract":"Aims: Gastrointestinal stromal tumors (GISTs) account for about 80% of the mesenchymal tumors of the GI tract. About 5000-6000 patients are diagnosed in the United States (US) alone, and up to 14.5 cases per million discovered in Europe annually. Avapritinib (AVP) is a potent selective targeted medication that has been recently approved, by the US Food and Drug Administration, in 2020 for treatment of GISTs. AVP is currently considered the first-line treatment for mutant GIST, which is resistant to other medications. This in turn stimulates the need for fast, green, and efficient methods for routine AVP estimation in quality control and clinical studies.Materials and methods: The proposed approach designs a spectrofluorimetric tool to estimate AVP in different matrices, based on a nucleophilic substitution reaction. A highly fluorescent product was measured at 535 nm following excitation at 470 nm. The research procedure was bioanalytically validated within AVP range between 80 and 900 ng mL-1, where the limit of quantitation (LOQ) was 15.78 ng mL-1.Conclusion: The developed approach was successfully applied to investigate AVP in content uniformity testing of tablet dosage forms, and biological plasma in AVP pharmacokinetic study. The proposed approach could be recommended for AVP therapeutic drug monitoring.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"31-40"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of highly sensitive, multiplex immunoassay platforms for streamlined clinical cytokine quantification. 流式临床细胞因子定量的高灵敏度、多重免疫分析平台的比较。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2024-12-20 DOI: 10.1080/17576180.2024.2442190

Kevin McKinski, Huaping Tang, Kai Wang, Mary Birchler, Mike Wright

{"title":"Comparison of highly sensitive, multiplex immunoassay platforms for streamlined clinical cytokine quantification.","authors":"Kevin McKinski, Huaping Tang, Kai Wang, Mary Birchler, Mike Wright","doi":"10.1080/17576180.2024.2442190","DOIUrl":"10.1080/17576180.2024.2442190","url":null,"abstract":"Introduction: Selecting the optimal platforms to quantitate cytokines is challenging due to varying performance and the plethora of options available.Aims: To compare performance of three highly sensitive, multiplex assays on three different platforms - MSD S-plex, Olink Target 48, and Quanterix SP-X - to MSD V-plex which is widely used for quantitative cytokine assay.Methods: Serum and stimulated plasma samples were analyzed across each platform. The proportion of quantifiable samples was compared for each analyte and correlation analyses were performed to relate the data. For MSD S-plex, parallelism and antibody pair knockdown experiments gauged specificity of the kit.Results: MSD S-plex was the most sensitive multiplex platform followed by Olink Target 48, Quanterix SP-X, and MSD V-plex. Concentrations across platforms differed greatly for some cytokines, but all platforms showed strong correlation. Results for MSD S-plex were confirmed by parallelism and knockdown.Conclusion: MSD S-plex should be a priority platform for ultra-sensitive assay. Olink Target 48 offers an enticing combination of sensitivity and multiplex capability that warrants consideration when many cytokines require quantitation. MSD V-plex, MSD S-plex and Olink quantitative assays offer high utility across drug development programs, but fit-for-purpose performance should be assessed on a per-analyte basis.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"17-29"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142862581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Accelerating isotope dilution LC-MS-based desmosine quantification for estimating elastin turnover.

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2025-02-01 DOI: 10.1080/17576180.2025.2452723

Elena Kuzmanova, Angela McIntyre, Maaz Syed, Zaid Iskandar, David E Newby, Matt J Bown, Anna-Maria Choy, Jeffrey Tj Huang

{"title":"Accelerating isotope dilution LC-MS-based desmosine quantification for estimating elastin turnover.","authors":"Elena Kuzmanova, Angela McIntyre, Maaz Syed, Zaid Iskandar, David E Newby, Matt J Bown, Anna-Maria Choy, Jeffrey Tj Huang","doi":"10.1080/17576180.2025.2452723","DOIUrl":"10.1080/17576180.2025.2452723","url":null,"abstract":"Aims: Circulating total desmosine, representing endogenous systemic elastin degradation activity, is an emerging biomarker for mortality risk in several diseases and aging. However, the existing analytical method takes more than 23 hours to complete, limiting its potential applications. The objective of this study was to shorten the turnover time of a stable isotope dilution liquid chromatogram mass spectrometry-based desmosine assay.Materials & methods: Plasma samples were analyzed using acid hydrolysis followed by solid-phase extraction and LC-MS. Two approaches to reduce assay time were tested: microwave-assisted acid hydrolysis and direct injection following solid-phase extraction.Results: The combination of acid hydrolysis at 180°C for 8 minutes and a low-volume elution design for solid-phase extraction reduced the overall assay time to ~ 30 minutes. The assay was validated with intra-day precision and accuracy ranging from 4% to 14%, and -7% to 9%, respectively, while inter-day precision and accuracy were 0% to 9% and 1% to 3%, respectively. The assay was tested in a cohort of patients with acute aortic dissection and control subjects, where desmosine concentrations were approximately three-fold higher in patients.Conclusions: These results demonstrated that rapid desmosine analysis can be achieved with the use of both microwave-assisted hydrolysis and streamlined solid-phase extraction.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"99-104"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143073697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0