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Development and application of a multi-sugar assay to assess intestinal permeability. 开发和应用多糖测定法评估肠道渗透性。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-07-18 DOI: 10.1080/17576180.2024.2374168
Nicole A Schneck, Ahmed Moghieb, Claire Teague, Hermes Licea Perez
{"title":"Development and application of a multi-sugar assay to assess intestinal permeability.","authors":"Nicole A Schneck, Ahmed Moghieb, Claire Teague, Hermes Licea Perez","doi":"10.1080/17576180.2024.2374168","DOIUrl":"10.1080/17576180.2024.2374168","url":null,"abstract":"<p><p><b>Aim:</b> Bioanalytical assays to measure rhamnose, erythritol, lactulose and sucralose in human urine and plasma were developed to support an indomethacin challenge study for intestinal permeability assessment in healthy participants.<b>Methods:</b> The multi-sugar assays utilized 5-μl sample matrix and a simple chemical derivatization with acetic anhydride, followed by RPLC-MS/MS detection.<b>Results:</b> Rhamnose and erythritol quantification was established between 1.00-1,000 μg/ml in urine and 250-250,000 ng/ml in plasma. For lactulose and sucralose, dynamic ranges of 0.1-100 μg/ml (urine) and 25-25,000 ng/ml (plasma) were applied for biological measurements.<b>Conclusion:</b> This work helped overcome some of the common analytical challenges associated with the bioanalysis of mono- and disaccharides and achieved improved limits of quantification.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457621/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632551","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
A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays. 欧洲生物分析论坛关于要求提供使用背景说明以成功开发和验证生物标志物检测方法的建议。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-08-05 DOI: 10.1080/17576180.2024.2376436
Kyra J Cowan, Ulrich Kunz, Peter Blattmann, Pratiksha Gulati, Richard Hughes, Lene Andersen, Joanne Goodman, Frazer Lambert, James Lawrence, Daniel Thwaites, Michaela Golob, Robert Nelson, Philip Timmerman
{"title":"A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.","authors":"Kyra J Cowan, Ulrich Kunz, Peter Blattmann, Pratiksha Gulati, Richard Hughes, Lene Andersen, Joanne Goodman, Frazer Lambert, James Lawrence, Daniel Thwaites, Michaela Golob, Robert Nelson, Philip Timmerman","doi":"10.1080/17576180.2024.2376436","DOIUrl":"10.1080/17576180.2024.2376436","url":null,"abstract":"<p><p>The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately depending on their purpose. Insights into understanding why the implementation of context-of-use in assay strategies has also shown that the key stakeholder, or requester for the biomarker data, is responsible for providing the context-of-use statement for all biomarker assay requests. Experts from across the industry haves repeatedly sought a cross-industry recommended format in which the context-of-use statement could be provided. In this manuscript, the European Bioanalysis Forum suggests a format for this.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457649/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888378","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
Biomonitoring of arsenic, lead, manganese and mercury in hair from a presumably exposed Uruguayan child population. 乌拉圭儿童头发中砷、铅、锰和汞的生物监测。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-11-15 DOI: 10.4155/bio-2023-0157
Fiorella Iaquinta, Ignacio Machado
{"title":"Biomonitoring of arsenic, lead, manganese and mercury in hair from a presumably exposed Uruguayan child population.","authors":"Fiorella Iaquinta, Ignacio Machado","doi":"10.4155/bio-2023-0157","DOIUrl":"10.4155/bio-2023-0157","url":null,"abstract":"<p><p><b>Aim:</b> To perform an exposure assessment of arsenic, manganese, mercury and lead levels in hair samples from children from poor neighborhoods. <b>Materials & methods:</b> A total of 38 Caucasian children were recruited with the consent of their parents or tutors. Determinations were performed by atomic absorption spectrometry. <b>Results & conclusion:</b> Results were 0.045-0.12 μg/g<sup>-1</sup> (arsenic), 0.56-2.05 μg/g<sup>-1</sup> (manganese) and 0.34-27.8 μg/g<sup>-1</sup> (lead). Lead results did not correlate with those previously reported in blood from the same individuals, suggesting that hair is not useful for exposure assessment of this contaminant. Mercury was determined for the first time in Uruguayan children showing levels <0.083 μg/g<sup>-1</sup>. Results revealed low-to-moderate metal exposure, except for some high lead findings.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"107590117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies. 一种检测抗聚乙二醇抗体的单酸免疫原性方法:聚乙二醇化治疗的前后剂量。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-11-22 DOI: 10.4155/bio-2023-0196
Issa Jyamubandi, Aanya Aamir, Jyotsna Kaur, Alen Sylvester, Richard Hughes, Sophia Li
{"title":"A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies.","authors":"Issa Jyamubandi, Aanya Aamir, Jyotsna Kaur, Alen Sylvester, Richard Hughes, Sophia Li","doi":"10.4155/bio-2023-0196","DOIUrl":"10.4155/bio-2023-0196","url":null,"abstract":"<p><p><b>Aim:</b> Preexisting anti-polyethylene glycol (PEG) antibodies (APAs) may affect the efficacy and safety of PEGylated compounds. Omontys<sup>®</sup> and Krystexxa<sup>®</sup> withdrawal and SARS-CoV-2 RNA vaccine anaphylaxis have all been linked to APAs. This project aimed to develop and validate a method to detect total antibodies against PEG, pre- and post-dose. <b>Materials & methods:</b> The repetitive, linear PEG structure prevented the use of a bridging homogenous format, hence the requirement to use a solid-phase extraction and acid dissociation assay coupled with the Meso Scale Discovery<sup>®</sup> platform. <b>Results & conclusion:</b> Using singlicate analysis, the method was validated to successfully detect APA pre- and post-dose, with a crucial aspect of the method being the preparation of an appropriate negative control.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138290192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
LC-MS/MS methods for direct measurement of sepiapterin and tetrahydrobiopterin in human plasma and clinical applications. LC-MS/MS 方法直接测量人血浆中的sepiapterin 和四氢生物蝶呤及其临床应用。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-12-15 DOI: 10.4155/bio-2023-0144
Diksha Kaushik, Lan Gao, Kun Yuan, Bowen Tang, Ronald Kong
{"title":"LC-MS/MS methods for direct measurement of sepiapterin and tetrahydrobiopterin in human plasma and clinical applications.","authors":"Diksha Kaushik, Lan Gao, Kun Yuan, Bowen Tang, Ronald Kong","doi":"10.4155/bio-2023-0144","DOIUrl":"10.4155/bio-2023-0144","url":null,"abstract":"<p><p><b>Aim:</b> Tetrahydrobiopterin (BH<sub>4</sub>), a natural cofactor of aromatic amino acid hydroxylases, and sepiapterin, a natural precursor of BH<sub>4</sub>, are endogenously present in human plasma. This is the first report on methods for direct quantification of sepiapterin and BH<sub>4</sub> in human plasma by LC-MS/MS for pharmacokinetic assessment<b>. Materials & methods:</b> The analytes in plasma were harvested from blood that were treated with 10% ascorbic acid (AA) to a final concentration of 1% AA. <b>Results & conclusion:</b> The quantification methods were validated for calibration ranges of 0.75-500 ng/ml and 0.5-500 ng/ml for sepiapterin and BH<sub>4</sub>, respectively. Quantification of analytes was challenging due to their susceptibility to redox reactions. The validated methods were utilized successfully to support clinical development of sepiapterin.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138796669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar. 信噪比评估阿达木单抗生物仿制药免疫反应的大小、动力学和药代动力学影响。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2023-11-30 DOI: 10.4155/bio-2023-0152
Davide Guerrieri, Matej Horvat, Jamie Fan, Jessie Wang, Lena Lemke, Oliver von Richter, Johann Poetzl
{"title":"Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar.","authors":"Davide Guerrieri, Matej Horvat, Jamie Fan, Jessie Wang, Lena Lemke, Oliver von Richter, Johann Poetzl","doi":"10.4155/bio-2023-0152","DOIUrl":"10.4155/bio-2023-0152","url":null,"abstract":"<p><p><b>Background:</b> The antidrug antibody (ADA) signal-to-noise (S/N) ratio was explored as a novel immunogenicity measure to evaluate the immune response of healthy subjects to a single dose of GP2017, an adalimumab biosimilar. <b>Methodology/results:</b> Bioanalytical methods used for the analysis of ADA S/N ratios and ADA titers were validated for sensitivity, precision and drug interference. ADA S/N ratios strongly correlated with ADA titers. Correlations between ADA area under the curve and ADA<sub>max</sub> and pharmacokinetics (PK) were stronger for ADA S/N ratio than for ADA titers. <b>Conclusion:</b> ADA S/N ratio allowed for a more sensitive evaluation of the magnitude and kinetics of the immune response, was better correlated with adalimumab PK and was superior to ADA titers in assessing the impact of the immune response on PK.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138457588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Covalent organic frameworks: spotlight on applications in the pharmaceutical arena. 共价有机框架：聚焦制药领域的应用。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-03-06 DOI: 10.4155/bio-2023-0256
Pushpa Pilli, Hema Sree Kommalapati, Vijaya Madhyanapu Golla, Rahul Khemchandani, Roshitha Kunnath Ramachandran, Gananadhamu Samanthula
{"title":"Covalent organic frameworks: spotlight on applications in the pharmaceutical arena.","authors":"Pushpa Pilli, Hema Sree Kommalapati, Vijaya Madhyanapu Golla, Rahul Khemchandani, Roshitha Kunnath Ramachandran, Gananadhamu Samanthula","doi":"10.4155/bio-2023-0256","DOIUrl":"10.4155/bio-2023-0256","url":null,"abstract":"<p><p>Covalent organic frameworks (COFs) have much potential in the field of analytical separation research due to their distinctive characteristics, including easy modification, low densities, large specific surface areas and permanent porosity. This article provides a historical overview of the synthesis and broad perspectives on the applications of COFs. The use of COF-based membranes in gas separation, water treatment (desalination, heavy metals and dye removal), membrane filtration, photoconduction, sensing and fuel cells is also covered. However, these COFs also demonstrate great promise as solid-phase extraction sorbents and solid-phase microextraction coatings. In addition to various separation applications, this work aims to highlight important advancements in the synthesis of COFs for chiral and isomeric compounds.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11235138/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140038687","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
Bioanalysis Rising Star Award 2024: interviews with the finalists. 2024 年生物分析新星奖：采访入围者。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-07-01 DOI: 10.1080/17576180.2024.2365591
Karan Agrawal, Monique Ryan, Tomislav Caval, Naamah Maundrell
{"title":"Bioanalysis Rising Star Award 2024: interviews with the finalists.","authors":"Karan Agrawal, Monique Ryan, Tomislav Caval, Naamah Maundrell","doi":"10.1080/17576180.2024.2365591","DOIUrl":"10.1080/17576180.2024.2365591","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465909","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
A comprehensive LC-MS based study of factors influencing biotinylation of critical reagents. 基于 LC-MS 的关键试剂生物素化影响因素综合研究。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-09-04 DOI: 10.1080/17576180.2024.2394317
Wanlu Qu, Jim Glick, Paola Dessanti, Jennifer Cunliffe
{"title":"A comprehensive LC-MS based study of factors influencing biotinylation of critical reagents.","authors":"Wanlu Qu, Jim Glick, Paola Dessanti, Jennifer Cunliffe","doi":"10.1080/17576180.2024.2394317","DOIUrl":"10.1080/17576180.2024.2394317","url":null,"abstract":"<p><p><b>Aim:</b> Critical reagents (CR) are applied in ligand binding assays (LBA) and biotinylation is a widely conjugation method used for critical reagents. However, insufficient characterization and inconsistent biotinylation can lead to LBA failures and necessitate extensive troubleshooting. This publication developed the detection of biotinylated CR and evaluates efficiency of biotinylation conditions to ensure the reliability of reagents and accuracy when implemented in LBA.<b>Materials & methods:</b> Intact mass analysis was applied to characterize a CR with complex glycosylation and biotinylation patterns. Peptide mapping was developed to identify the biotinylation sites.<b>Results</b>: Biotinylation degrees and sites were clearly illustrated.<b>Conclusion:</b> A CR and its biotinylation were successfully characterized. The relationship between biotinylation efficiency and labeling conditions was clearly illustrated.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457598/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142124701","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
Bioanalytical Quality Assurance: a Tesla with a trafficator? 生物分析质量保证：带流量计的特斯拉？
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-03-01 DOI: 10.4155/bio-2023-0248
Anthony B Jones
{"title":"Bioanalytical Quality Assurance: a Tesla with a trafficator?","authors":"Anthony B Jones","doi":"10.4155/bio-2023-0248","DOIUrl":"10.4155/bio-2023-0248","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11216612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139995454","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
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