Bioanalysis最新文献_第5页

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 2: "The How"). 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 2 部分："如何"）。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-01-01 Epub Date: 2024-11-06 DOI: 10.1080/17576180.2024.2418251

Nico van de Merbel, Mark Jean Gnoth, Amanda Wilson, 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 2: \"The How\").","authors":"Nico van de Merbel, Mark Jean Gnoth, Amanda Wilson, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love, Stephane Muccio, Matthew Barfield, Rob Wheller, Philip Timmerman","doi":"10.1080/17576180.2024.2418251","DOIUrl":"10.1080/17576180.2024.2418251","url":null,"abstract":"Following up on our most recent discussion paper focussing 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 how'. 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":"71-77"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11801336/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589985","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

The advantages of working with a central laboratory for conducting clinical trials. 与中心实验室合作开展临床试验的优势。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-11-18 DOI: 10.1080/17576180.2024.2424126

Venkataramana Kandi

引用次数: 0

The use of surrogate matrices in bioanalytical preclinical safety testing using chromatographic methods: a recommendation from the European Bioanalysis forum. 使用色谱法在生物分析临床前安全性测试中使用替代基质：欧洲生物分析论坛的建议。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-10-23 DOI: 10.1080/17576180.2024.2416360

Lee Goodwin, Stuart McDougall, Mark Jean Gnoth, Daniel Mascher, Luca Ferrari, Robert Wheller, Hayley Hawthorne, Josep-Maria Jansat, Joerg Faber, Peter Huber, Alessandro Greco, Lars F Eggers, Matthias Sury, Jens-Jakob Karlsson, Sune Hove Sporring, Susanne Globig, Nico van de Merbel, Philip Timmerman

{"title":"The use of surrogate matrices in bioanalytical preclinical safety testing using chromatographic methods: a recommendation from the European Bioanalysis forum.","authors":"Lee Goodwin, Stuart McDougall, Mark Jean Gnoth, Daniel Mascher, Luca Ferrari, Robert Wheller, Hayley Hawthorne, Josep-Maria Jansat, Joerg Faber, Peter Huber, Alessandro Greco, Lars F Eggers, Matthias Sury, Jens-Jakob Karlsson, Sune Hove Sporring, Susanne Globig, Nico van de Merbel, Philip Timmerman","doi":"10.1080/17576180.2024.2416360","DOIUrl":"10.1080/17576180.2024.2416360","url":null,"abstract":"Within the bioanalytical community, the use of blank matrix from preclinical animals for bioanalytical method validation and sample analysis is common practice and required in the context of guidelines for bioanalytical method validation. At the same time, its use has been challenged by the scientific community for decades, since there is ample scientific evidence to allow the use surrogate matrices for this purpose. Nevertheless, legacy and current regulatory thinking continues to be reluctant to allow the use of surrogate matrices in bioanalytical testing except for so-called rare matrices. As part of ongoing discussions in relation to the ICH M10 Guideline, the European Bioanalysis Forum re-challenges the unnecessary use of blank matrices from preclinical animals and believes that, as part of community responsibility and ethical standards and when supported by data, the use of surrogate matrices should become widely accepted. It is in this context that targeted experiments were conducted within the European Bioanalysis Forum to gather additional data and re-open the discussions with all involved and that it should become acceptable to use surrogate matrices wherever possible.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1199-1202"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11703457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493916","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

Iron oxide nanozymes as versatile analytical tools: an overview of their application as detection technique. 作为多功能分析工具的氧化铁纳米酶：作为检测技术的应用概述。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-11-26 DOI: 10.1080/17576180.2024.2415779

Rana Said, Asma Ghazzy, Ashok K Shakya, Afnan Al Hunaiti

{"title":"Iron oxide nanozymes as versatile analytical tools: an overview of their application as detection technique.","authors":"Rana Said, Asma Ghazzy, Ashok K Shakya, Afnan Al Hunaiti","doi":"10.1080/17576180.2024.2415779","DOIUrl":"10.1080/17576180.2024.2415779","url":null,"abstract":"Iron oxide nanozymes (IONzymes) have become fundamental components in various analyte detection methodologies such as colorimetric, electrochemistry, fluorescence and luminescence. Their tunability, stability and the possibility of modification, alongside their ability to mimic the catalytic properties of natural enzymes like peroxidase, render them invaluable in analytical chemistry. This review explores the diverse applications of IONzymes across analytical chemistry, with a particular highlighting on their roles in different detection techniques and their potential in biomedical and diagnostic applications. This information would be valuable for researchers and practitioners in the fields of analytical chemistry, biochemistry, biotechnology and materials science who are interested in applying IONzymes in their work. In essence, this review article on iron oxide nanozymes in analytical chemistry would serve as a valuable resource for researchers, educators and industry professionals, offering insights, guidance and inspiration for further study and application of this promising class of nanomaterials.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1261-1278"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142725361","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

Green HPLC method for determination of paracetamol and ibuprofen in human plasma: applications to pharmacokinetics. 测定人血浆中扑热息痛和布洛芬的绿色高效液相色谱法：在药代动力学中的应用。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-11-18 DOI: 10.1080/17576180.2024.2421704

Sally A Helmy, Heba M ElBedaiwy, Soha Am Helmy, Rama A Alamri, Renad Mh Alhusayni, Ibtihal Ay Almashhadi, Aryam Sg Alharbi, Shouq Ad Alharbi, Alaa A Ahmed-Anwar, Mahmoud A Mohamed

{"title":"Green HPLC method for determination of paracetamol and ibuprofen in human plasma: applications to pharmacokinetics.","authors":"Sally A Helmy, Heba M ElBedaiwy, Soha Am Helmy, Rama A Alamri, Renad Mh Alhusayni, Ibtihal Ay Almashhadi, Aryam Sg Alharbi, Shouq Ad Alharbi, Alaa A Ahmed-Anwar, Mahmoud A Mohamed","doi":"10.1080/17576180.2024.2421704","DOIUrl":"10.1080/17576180.2024.2421704","url":null,"abstract":"Using a straightforward, sensitive and precise liquid chromatographic approach, it is now possible to concurrently measure the amounts of ibuprofen (IBU) and paracetamol (PAR) in human plasma. A µ BondapakTM C18 column (300 mm × 3.9 mm, 15-20 μm) demonstrated acceptable separation when utilizing a mobile phase of 10 mM disodium hydrogen orthophosphate solution and acetonitrile at an 80:20, v/v ratio. The elution was isocratic at room temperature and a flow rate of 1.0 milliliters per minute. The UV detector was set to monitor PAR and IS (tinidazole) for 6.5 min at 254 nm, then IBU for the next 3 min at 220 nm. PAR and IBU showed linearity across the 0.05 to 100 µg/ml concentration range. The precision of the measurements ranged from 98.5% to 105% for PAR and from 95.1% to 102.8% for IBU. The average drug recovery rate was 100% for PAR and 98.9% for IBU. This method was effectively utilized to assess samples from an actual population administered PAR and IBU (325/200 mg) for pharmacokinetic research. The technique employs green and white tools to evaluate their environmental sustainability and efficacy. The suggested strategy was implemented utilizing the Six Sigma method.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1249-1260"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646840","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

Quantification of MDR-TB drug JBD0131 and its metabolite in plasma via UPLC-MS/MS: application in first-in-human study. 通过 UPLC-MS/MS 对血浆中的 MDR-TB 药物 JBD0131 及其代谢物进行定量：在首次人体试验中的应用。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-10-07 DOI: 10.1080/17576180.2024.2404311

Tiantao Gao, Xiaoxue Ou, Jia Miao, Yongping Qin

{"title":"Quantification of MDR-TB drug JBD0131 and its metabolite in plasma via UPLC-MS/MS: application in first-in-human study.","authors":"Tiantao Gao, Xiaoxue Ou, Jia Miao, Yongping Qin","doi":"10.1080/17576180.2024.2404311","DOIUrl":"10.1080/17576180.2024.2404311","url":null,"abstract":"Aim: JBD0131, a novel anti-multidrug-resistant tuberculosis (MDR-TB) drug, can target and inhibit the synthesis of mycolic acids, which are crucial components of the cell wall of the Mycobacterium tuberculosis complex. To support the results of this clinical trial in healthy subjects, development of a specific and accurate quantification method for detecting JBD0131 and its metabolite DM131 in human plasma is needed.Materials & methods: Samples with prior added stabilizer were pretreated by protein precipitation method and the extracts were subjected to ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). The m/z transitions for the precursor/product ion pairs were 402.1/273 for JBD0131, 333.1/273 for DM131 and 386.1/257 for the internal standard (IS).Results: This method showed good linearity from 1 to 2000 ng/ml for JBD0131 and 0.25 to 500 ng/ml for DM131 and was validated in terms of selectivity, linearity, accuracy, precision, matrix effect, recovery of pretreament and stability.Conclusion: This method was sensitive and specific for measuring the plasma concentrations of JBD0131 and its metabolites. And it was applied for the investigation of the pharmacokinetics of JBD0131 and DM131 in a clinical trial.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1229-1240"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380021","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

Transforming drug discovery: the impact of AI and molecular simulation on R&D efficiency. 改变药物发现：人工智能和分子模拟对研发效率的影响。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-12-06 DOI: 10.1080/17576180.2024.2437283

Hiroaki Iwata

引用次数: 0

A platform immunoassay for the quantification of biotherapeutics with glycine-serine linkers. 一种用于定量甘氨酸-丝氨酸连接物的生物治疗药物的平台免疫分析法。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-12-04 DOI: 10.1080/17576180.2024.2435804

Alexander Pöhler, Michael Antony, Janine Faigle, Gregor Jordan, Roland F Staack, Gregor P Lotz

{"title":"A platform immunoassay for the quantification of biotherapeutics with glycine-serine linkers.","authors":"Alexander Pöhler, Michael Antony, Janine Faigle, Gregor Jordan, Roland F Staack, Gregor P Lotz","doi":"10.1080/17576180.2024.2435804","DOIUrl":"10.1080/17576180.2024.2435804","url":null,"abstract":"Assessing the pharmacokinetics of biotherapeutics is essential across all phases of drug development to understand drug exposure. At early stages, platform drug quantification immunoassays offer a versatile method for evaluating exposure for diverse biotherapeutics when specific reagents are not yet available, providing fast data for molecules with common structural features. To ensure clearly defined bioanalytical data, it is essential to conduct interference testing for anti-drug antibodies (ADA) or soluble target (starget), although these assays measure total exposure. In this study, a novel platform immunoassay has been developed that detects a variety of multi-domain drugs with the common structural feature of glycine-serine (G/S) linkers. The assay was successfully qualified and is suitable for early total drug exposure analysis of compounds with G/S linkers. Qualification parameters, including accuracy and precision, were successfully determined, and interference from ADAs and starget was assessed. ADA and starget interference tests showed no impact for one compound, but may affect total drug detection for another. Therefore, it remains recommended to assess the impact of ADAs and starget on assay performance. Overall, the platform G/S linker assay provides a rapid alternative for total exposure analysis in early development when specific assays are unavailable.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1241-1248"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11703356/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779422","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

Enantioselective electrochemical detection of a L-and D-serine at polyvinylpyrrolidone-modified platinum electrode. 在聚乙烯吡咯烷酮修饰的铂电极上对 L 型和 D 型丝氨酸进行对映选择性电化学检测。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-11-20 DOI: 10.1080/17576180.2024.2422209

Mohammad Amayreh, Mohammed Khair Hourani

{"title":"Enantioselective electrochemical detection of a L-and D-serine at polyvinylpyrrolidone-modified platinum electrode.","authors":"Mohammad Amayreh, Mohammed Khair Hourani","doi":"10.1080/17576180.2024.2422209","DOIUrl":"10.1080/17576180.2024.2422209","url":null,"abstract":"Aim: By modifying the Pt electrode with polyvinylpyrrolidone, the distinct oxidation potentials of L and D-serine were markedly increased for both isomers.Methods & results: CV was used for Pt electrode modification with PVP. Twenty cycles was reasonable for Pt modification. K3[Fe(CN)6] CV experiments investigated reversibility of the Fe(III) redox reaction and the enhancement of electron transfer at the PVP-Pt electrode. L and D-serine showing an oxidation peak potential at 0.394 V and 0.468 V, respectively. A linear relationship between the anodic oxidation current extracted from the CVs and the standard concentrations of L-serine and D-serine solutions was obtained with R2 = 0.99. The dynamic range for D-serine was from 0.5 to 20 mM with a LOD of 0.16 mM, while for L-serine, was from 2.5 to 20 mM with a detection limit of 0.27 mM. Using DPV, the dynamic range was 0.05-1.0 µM for D-serine with a detection limit of 0.0103 µM. The standard deviation ranged from 0.212 to 0.38 across ten determinations per concentration.Conclusion: A separation by 74 mV between the oxidation peaks of L and D-serine was achieved with remarkable enhancement in oxidation current for both isomers. PVP-Pt electrode can detect D-serine in the presence of DL-serine.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1219-1227"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11727866/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674923","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

Moving into the cloud: a summary from a European Bioanalysis forum workshop on introducing cloud applications in bioanalytical laboratories. 迈入云时代：欧洲生物分析论坛关于在生物分析实验室引入云应用的研讨会摘要。

IF 1.9 4区医学

Bioanalysis Pub Date : 2024-12-01 Epub Date: 2024-10-30 DOI: 10.1080/17576180.2024.2416357

Cecilia Arfvidsson, Katja Zeiser, Lars-Ole Andresen, David Van Bedaf, Harm Buddiger, Christopher Jones, Werner Schauerte, Jens Sigh, Milan Vagaday, Philip Timmerman

引用次数: 0