Bioanalysis最新文献

{"title":"Feedback from the 10th European Bioanalysis Forum Young Scientist Symposium and from the Science Café discussions on sustainability in bioanalysis.","authors":"Sanam Ahmad, Fabian Gärtner, Rosie Penford, Lisa Wolter, Sonya Belle, Alexandra Bushby, Mariana Carneiro Da Cunha, Brian Dan, Andrea Di Ianni, Caroline Dumolyn, Marie Sole Giordano, Eva Hanckmann, Jayshree Maher, Elisa Milandri, Kyriel Pineault, Amelia Roberts, Marie Reille-Seroussi, Sara Russo, Manca Spendal, Claire Szuster, Kevin Vandenbroucke, Aline Vollmer, Friederike Vogt, Simon Wellenberg, Philip Timmerman","doi":"10.1080/17576180.2025.2479963","DOIUrl":"https://doi.org/10.1080/17576180.2025.2479963","url":null,"abstract":"<p><p>Since 2014, the European Bioanalysis Forum has organized the Young Scientist Symposium, providing early-career scientists with unique development opportunities. By fostering a peer community, this initiative has successfully lowered barriers to engagement in cross-company, pre-competitive interactions. Since 2018, the symposium has included the Science Café roundtable, further reinforcing the European Bioanalysis Forum's commitment to supporting young scientists beyond their scientific expertise by promoting broader professional development.This manuscript summarizes discussions from the 10th Young Scientist Symposium, held in Hasselt, Belgium, from May 15-17, 2024. The symposium featured presentations on new technologies, biomarker assays, troubleshooting, and microsampling. Additionally, it provides insights from the Science Café discussions, which focused on sustainability in the bioanalytical laboratory.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-6"},"PeriodicalIF":1.9,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699553","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}

{"title":"A chiral HPLC and pharmacokinetic approach of 1-(4-bromophenyl)-6,7-dimethoxy-3,4-dihydroisoquinoline-2(1H)-sulfonamide.","authors":"Peddaguravagari Mounika, Mariya Shelby, Chethan K S, Honnavalli Yogish Kumar, Bannimath Gurupadayya","doi":"10.1080/17576180.2025.2481023","DOIUrl":"https://doi.org/10.1080/17576180.2025.2481023","url":null,"abstract":"<p><strong>Aim: </strong>The main purpose of the study is to establish Bioanalytical method development for enantiomeric divergence and Stereoselective Pharmacokinetic activity of 1-(4-bromophenyl)-6,7-dimethoxy-3,4-dihydroisoquinoline-2(1H)-sulfonamide(B06).</p><p><strong>Background: </strong>Isoquinoline derivatives have various activities like anticancer, anti-convulsant etc. The proposed project is mainly focused on anti-cancer activity of the synthesized B-06 compound as it shown very good cytotoxicity activity on MBA-MD-231 and MCF-7 cell lines by using SRB assay.</p><p><strong>Method: </strong>The specified project was completed with HPLC and an amylose chiral column. The bioanalytical approach was developed and tested using Wister Albino rats in compliance with USFDA Guidelines and expanded to include pharmacokinetic activities.</p><p><strong>Result: </strong>Data that had previously been published was used to design the B06 compound. RT of 9.578 and 7.076 minutes were observed for (R) &; (S) B06 Compound. Within-run and between-run precision for S-enantiomer varied from 0.28 to 6.078%, while R-enantiomer was found to range from 0.34 to 6.08%. Recovery rates ranged from 80.06% to 92.60% for both enantiomers. Pharmacokinetic investigations were developed and validated by using PKSolver software with Microsoft Excel.</p><p><strong>Conculsion: </strong>We successfully established optimized bioanalytical method for pharmacokinetic study were both the enantiomers were properly separated. In pharmacokinetic activity we found that the enantiomers are non-stereoselective having same absorption rate.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-9"},"PeriodicalIF":1.9,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691012","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}

{"title":"Recent advances and future perspectives of biosensing technologies in anti-doping applications.","authors":"Ruixuan Li, Yudie Pan, Zixin Ye, Beidi Zhang, Gaozhi Ou","doi":"10.1080/17576180.2025.2481020","DOIUrl":"https://doi.org/10.1080/17576180.2025.2481020","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-4"},"PeriodicalIF":1.9,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691014","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}

{"title":"Advances in green sample preparation methods for bioanalytical laboratories focusing on drug analysis.","authors":"Rajeev Jain, Bharti Jain, Lateefa A Al-Khateeb, Sarah Alharthi, Mohammad M Ghoneim, Mohamed AbdElrahman, Abdullah S Alanazi","doi":"10.1080/17576180.2025.2481026","DOIUrl":"10.1080/17576180.2025.2481026","url":null,"abstract":"<p><p>Bioanalytical laboratories face significant challenges in sample preparation due to the complexity of biological matrices and the low concentrations of target analytes. This review focuses on advances in green sample preparation (GSP) techniques tailored to meet these challenges while promoting sustainability. Innovations in sorbents, including metal-organic frameworks (MOFs), magnetic nanoparticles (MNPs), sol-gel-based materials, molecularly imprinted polymers (MIPs), carbon-based materials, and natural sorbents like cellulose and kapok fiber, have enhanced extraction efficiency and selectivity. Green solvents such as deep eutectic solvents (DES), ionic liquids (ILs), supramolecular solvents (SUPRAs), and switchable hydrophilicity solvents (SHSs) further reduce environmental impact by minimizing toxic solvent use. This review highlights their use in drug analysis, emphasizing their roles in enhancing extraction efficiency, selectivity, and environmental sustainability. Recent applications demonstrate the integration of these sorbents and solvents into bioanalytical workflows, significantly improving analytical performance while adhering to Green Analytical Chemistry (GAC) principles. It is anticipated that this comprehensive review will aid scholars in the formulation of selective, rapid, environmentally friendly, straightforward, sensitive, and precise analytical methodologies for bioanalysis, thereby promoting innovation and sustainability within drug analysis protocols.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-20"},"PeriodicalIF":1.9,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699626","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}

{"title":"Enhancing clinical research with pharmacogenomics: a practical perspective.","authors":"Xiaolong Tom Zhang, Jacob Blacutt, Thomas Lloyd, Mike Mencer, Vicky Pratt, Jayaprakash Kotha, Lona Sheeran, Sherilyn Adcock","doi":"10.1080/17576180.2025.2481019","DOIUrl":"https://doi.org/10.1080/17576180.2025.2481019","url":null,"abstract":"<p><p>Pharmacogenomics (PGx) is transforming therapeutic development by providing insights into how genetic variations influence drug response, safety, and efficacy. This review provides a structured analysis of PGx in clinical research, beginning with an overview of key genes involved in drug metabolism, transport, and targets. Following this, it examines strategies for identifying PGx-relevant genes, including phenotype-driven, hypothesis-driven, population-focused, and clinical-driven approaches. Technical platforms such as PCR, MassARRAY, and next-generation sequencing are analyzed for their suitability in PGx studies. The discussion then shifts to assay validation processes, covering both analytical and clinical validation, to ensure data reliability in clinical trials. Finally, regulatory expectations for PGx in clinical trials are discussed, focusing on key requirements across all phases of drug development. This review aims to provide a clear and practical framework for integrating PGx into clinical research to enhance drug safety, efficacy, and personalized medicine.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-13"},"PeriodicalIF":1.9,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676720","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}

{"title":"Development and validation of a sensitive method to quantify a poorly ionized drug, pocapavir, in C57BL/6 mouse plasma.","authors":"Renmeng Liu, Ashley Davie, Elaine To, Yurong Lai","doi":"10.1080/17576180.2025.2480533","DOIUrl":"https://doi.org/10.1080/17576180.2025.2480533","url":null,"abstract":"<p><strong>Background: </strong>Pocapavir is an antiviral agent that has shown in vitro potency against poliovirus. It necessitates investigation into its <i>in</i> <i>vivo</i> efficacy and safety profiles. Therefore, the development of a sensitive and reliable bioanalytical method to quantify pocapavir drug levels and characterize its pharmacokinetic (PK) profiles is imperative.</p><p><strong>Research design and methods: </strong>Given pacapavir's low ionization efficiency, the utilization of atmospheric pressure chemical ionization (APCI) is employed to enhance the assay sensitivity. The developed method is validated and subsequently implemented in a mouse PK study.</p><p><strong>Results: </strong>As the first reported bioanalytical method for pocapavir, the method is developed and validated through a full method validation in accordance with the principles of Good Laboratory Practice (GLP), with all evaluated parameters meeting the stipulated acceptance criteria.</p><p><strong>Conclusions: </strong>The validated bioanalytical method is suitably equipped to quantify pocapavir while bolstering preclinical and potential applications for first-in-human (FIH) PK characterizations.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-6"},"PeriodicalIF":1.9,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676717","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}

{"title":"Conquering PROTAC molecular design and drugability.","authors":"Ritesh P Bhole, Sonali Labhade, Shilendra S Gurav","doi":"10.1080/17576180.2025.2481021","DOIUrl":"https://doi.org/10.1080/17576180.2025.2481021","url":null,"abstract":"<p><p>PROTACs are reshaping drug discovery by enabling targeted protein degradation, overcoming the limitations of traditional inhibitors, and addressing previously \"undruggable\" proteins. The present perspective explores advancements in PROTAC molecular design, focusing on ligand discovery, E3 ligase recruitment, and ternary complex optimization. Integrating AI-driven modeling, FBDD, and SBDD accelerates PROTAC development. In contrast, emerging innovations, such as PHOTACs, hypoxia-responsive systems, and Ab-PROTACs, enhance precision and reduce systemic toxicity. Clinical successes, including ARV-110 for castration-resistant prostate cancer and ARV-471 for breast cancer, exemplify their ability to overcome resistance and provide durable effects. PROTACs are expanding into neurodegenerative diseases and rare conditions, highlighting their versatility. By addressing challenges in pharmacokinetics, safety, and scalability, PROTACs are poised to revolutionize precision medicine. This article presents a forward-looking perspective on conquering the molecular design and drugability of PROTACs, paving the path for transformative therapies.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-16"},"PeriodicalIF":1.9,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143668917","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}

{"title":"Singlicate analysis in ADA assays: comparing assay performance in duplicate and singlicate formats.","authors":"Zhihua Jiang","doi":"10.1080/17576180.2025.2464421","DOIUrl":"10.1080/17576180.2025.2464421","url":null,"abstract":"<p><p>Singlicate anti-drug antibody (ADA) analysis is gaining recognition as a promising approach to optimize immunogenicity assessment. It offers significant benefits in terms of cost-effectiveness and aligns with patient-centric principles. However, its successful implementation requires a thorough understanding of its impacts on assay performance. In this perspective, we review recent case studies comparing singlicate and duplicate formats, focusing on cut point factors and sample result agreement, and seek to discuss how singlicate influences assay cut points and explore considerations for low positive control criteria under singlicate conditions. Furthermore, we propose a strategy for implementing singlicate analysis in both new and existing ADA assays, hoping to contribute to ongoing discussions in this area.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"371-377"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390021","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}

{"title":"The development and evolution of biological AMS at Livermore: a perspective.","authors":"Graham Bench","doi":"10.1080/17576180.2025.2460391","DOIUrl":"10.1080/17576180.2025.2460391","url":null,"abstract":"<p><p>Biological accelerator mass spectrometry (AMS) provides ultrasensitive carbon-14 isotopic analysis enabling a deeper understanding of human health concerns by enabling quantification of pharmacokinetics and other molecular endpoints directly in humans. It enables environmentally and human relevant studies of metabolic pathways through the use of very low concentrations of labeled metabolic substrates in cells and organisms. Here, we discuss why AMS is an important tool for the biosciences, the development and evolution of biological AMS at Livermore and discuss technical refinements that will improve the efficiency of operation for the measurement of ultra-trace levels of ¹⁴C, which, long term, will enable greater ease of use and sample throughput.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"345-354"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188116","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}

{"title":"2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (<u>Part 1A</u> - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis <u>Part 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).","authors":"John Wojcik, Timothy Sikorski, Jian Wang, Yue Huang, Hiroshi Sugimoto, Mike Baratta, Eugene Ciccimaro, Rachel Green, Wenying Jian, Sumit Kar, Yeoun Jin Kim, Michael Lassman, Susovan Mohapatra, Mark Qian, Anton I Rosenbaum, Hetal Sarvaiya, Yu Tian, Inna Vainshtein, Long Yuan, Lin Tao, Allena Ji, Christopher Kochansky, Haibo Qiu, Estelle Maes, Lin-Zhi Chen, Megan Cooley, Dawn Dufield, Elizabeth Hyer, Jay Johnson, Wenkui Li, Aihua Liu, Yang Lu, John Meissen, Joe Palandra, Xiaonan Tang, Adam Vigil, Wei Wei, Stephen Vinter, Yongjun Xue, Li Yang, Naiyu Zheng, Kimberly Benson, Fred McCush, Zhenmin Liang, Lee Abberley, Matthew Andisik, Marcela Araya, Seongeun Julia Cho, Liliana Colligan, Arindam Dasgupta, Markus Dudek, Anna Edmison, Sally Fischer, Brian Folian, Fabio Garofolo, Akiko Ishii-Watabe, Dany Ivanova, Sonja Kwadijk-de Gijsel, Lina Luo, Michael McGuinness, Christine O 'Day, Reza Salehzadeh-Asl, João Tavares Neto, Tom Verhaeghe, Katty Wan, Emma Whale, Weili Yan, Eric Yang, Jinhui Zhang","doi":"10.1080/17576180.2025.2450194","DOIUrl":"10.1080/17576180.2025.2450194","url":null,"abstract":"<p><p>The 18^th Workshop on Recent Issues in Bioanalysis (18^th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18^th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.Moreover, in-depth workshops on \"IVDR Implementation in EU & Changes for LDT in the US\" and on \"Harmonization of Vaccine Clinical Assays Validation\" were the special features of the 18^th edition.As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues.This 2024 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2024 edition of this comprehensive White Paper has been divided into three parts for editorial reasons.This publication (Part 1) covers in Part 1A the Recommendations on Mass Spectrometry Assays and Regulated Bioanalysis/BMV and in Part 1B the Regulatory Inputs on these topics. Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) and Part 2 (Biomarkers/BAV, IVD/CDx, LBA and Cell-Based Assays) are published in volume 17 of Bioanalysis, issues 3 and 4 (2025), respectively.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"299-337"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143036238","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}