Bioanalysis最新文献

{"title":"Microsampling techniques and patient-centric therapeutic drug monitoring of immunosuppressants.","authors":"Arkadiusz Kocur, Tomasz Pawiński","doi":"10.1080/17576180.2025.2477976","DOIUrl":"10.1080/17576180.2025.2477976","url":null,"abstract":"<p><p>Immunosuppressive pharmacotherapy after solid organ transplantation (SOT) requires therapeutic drug monitoring (TDM) for therapy individualization. The venous whole blood is still considered as routine matrix for monitoring immunosuppressive drug concentration. On the other hand, as an alternative, capillary blood collected using noninvasive sampling is convergent with a patient-centric approach. Despite their disadvantages regarding sample homogeneity and the hematocrit effect, well-known dried blood spot techniques have shown promising results. Volumetric absorptive microsampling (VAMS) and quantitative dried blood spot (qDBS) have successfully eliminated these unfavorable biased elements. Microsampling can be used in transplant recipients' care, mainly due to long-term therapy under control drug concentrations and the long distance between the place of the patient's residence and the diagnostic laboratory in the transplant center. The study aimed to discuss the clinical consequences of implementing microsampling techniques for TDM of immunosuppressants. Additionally, we have discussed the 'hot topics' in microsampling: home-based self-sampling, adherence to therapy monitoring, and drug concentration conversion to estimated traditional matrices. Finally, based on our experience and current practice, we propose best practices for microsampling implementation from bench to bedside. Microsampling techniques can potentially revolutionise immunosuppressive pharmacotherapy by enabling patient-centric individualisation in various subpopulations, significantly improving post-transplant care.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"413-427"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11959920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735603","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":"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":"10.1080/17576180.2025.2481020","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"389-392"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970731/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The changes necessary in the assessment of immunogenicity for the development of Biosimilars.","authors":"Johann Poetzl","doi":"10.1080/17576180.2025.2461373","DOIUrl":"10.1080/17576180.2025.2461373","url":null,"abstract":"<p><p>Immunogenicity knowledge and the analytical capabilities to characterize molecules have evolved within the last decade. This creates opportunities in Biosimilar development by applying new strategies to demonstrate similarity between a proposed Biosimilar to its Reference.Within Immunogenicity Risk Assessment for Biosimilars, in silico and in vitro immunogenicity assessment tools are being evaluated for their utility in Biosimilar development. An ISI including an Immunogenicity Risk Assessment is recommended for Biosimilars within the dossier of licensing applications to facilitate the review by Health Authorities and to explain the immunogenicity in conjunction with analytical and clinical data. Operational aspects should also be considered to refine immunogenicity testing of Biosimilars, e.g. S/N ratio and singlicate sample analysis.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"355-358"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143121955","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":"Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements for <i>in vitro</i> assays following the publication of ICH M12 guideline - a plea for context-of-use over ICH M10 standards.","authors":"Philip Timmerman, Steve White, Neil Adcock, Cecilia Arfvidsson, Matthew Barfield, Kyra Cowan, Luca Ferrari, Michaela Golob, Lee Goodwin, Richard Hughes, Tsvetelina Ivanova, Anna Laurén, Stuart McDougall, Robert Nelson, Nico van de Merbel, Tom Verhaeghe, Michael Wright","doi":"10.1080/17576180.2025.2468596","DOIUrl":"10.1080/17576180.2025.2468596","url":null,"abstract":"<p><p>The release of the ICH M12 Guideline on Drug Interaction Studies has reignited discussions around assay validation requirements for <i>in vitro</i> assays such as plasma protein-binding studies. Even though the ICH M12 does not directly reference the ICH M10 Guideline on Bioanalytical Method Validation and Sample Analysis, its release prompted further discussions on assay validation requirements for these studies during the 17th European Bioanalysis Forum Open Symposium held in Barcelona, Spain, from 19 to 21 November 2024, where we advocated for a Context-of-Use driven approach over rigid adherence to ICH M10 standards. Context-of-Use driven validation ensures assays are tailored to the specific scientific and regulatory needs, optimizing resource allocation and innovation in drug development. This short opinion paper explores the potential and undesired implications of ICH M12 on bioanalytical validation practices, highlights the distinction between exploratory assays and assays having a clinical impact, and underscores the necessity for tailored validation strategies.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"379-382"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11959917/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476090","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":"Bioanalytical methods in doping controls: a review.","authors":"Andreas Thomas, Katja Walpurgis, Nana Naumann, Thomas Piper, Mario Thevis","doi":"10.1080/17576180.2025.2460951","DOIUrl":"10.1080/17576180.2025.2460951","url":null,"abstract":"<p><p>The analytical and technological approaches employed in doping analysis are constantly reviewed and updated to allow for keeping pace with progresses in pharmaceutical and medicinal research and the therein inherent options of misuse as performance enhancing drugs or methods. Enormous changes, improvements, and developments have been achieved in recent years, particularly, but not exclusively, in the bioanalytical sector. Several of these new strategies are examined systematically in this review using examples from the World Anti-Doping Agency (WADA) list of banned substances and methods. The review includes, among others, the application of sophisticated new <i>in-vitro</i> models mimicking multi compartment models, investigation into new long-term metabolites for anabolic agents, the impact of a distinct gene mutation on the analysis of erythropoietin, studies on the development of new therapeutic protein-based drugs with myostatin inhibiting properties, methods applying the new molecular biological section used to uncover gene doping, and finally new approaches uncovering the prohibited use of autologous blood transfusion. All of these challenges and investigations support the ongoing progress in modern doping controls in the future and will help to fill the gap between the advance of cheating athletes and sport drug testing.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"359-370"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363534","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":"Improved real-world UHPLC-MS/MS iohexol analysis; thawed samples, improved calibration curve, and additional matrices.","authors":"A Mireille A Wessels, Lenneke A T Junier, Daan Touw, Jasper Stevens","doi":"10.1080/17576180.2025.2462429","DOIUrl":"10.1080/17576180.2025.2462429","url":null,"abstract":"<p><strong>Background: </strong>Plasma clearance of iohexol is used to measure glomerular filtration rate, for which a UHPLC-MS/MS analytical method was previously developed. In real-world conditions, samples may be thawed on arrival and sampled in unvalidated matrices, prompting the need for an improved validation. We aim to improve the method for iohexol determination in plasma with enhanced stability testing, optimized calibration curves, and partial validation in additional matrices.</p><p><strong>Methods: </strong>Stability testing was conducted up to 9 weeks at room temperature, 4°C, 37°C, and at 37°C with daily two-hour exposure to 55°C. Quintuplicate QC samples were analyzed on 3 days, comparing results from eight-point and two-point calibration curves. Matrix comparison was performed on quintuplicate QC samples in serum, heparin plasma, urine, EDTA whole blood, and heparin whole blood.</p><p><strong>Results: </strong>The method improvements were all compliant with the requirements for bioanalytical methods issued by the US FDA and European Medicines Agency.</p><p><strong>Conclusion: </strong>Human EDTA plasma samples can be stored up to 9 weeks at room temperature, 4°C, 37°C, and 37°C with 55°C daily temperature spikes. The samples can be analyzed using a two-point calibration curve and are partial validated for serum-, heparin plasma-, urine-, EDTA whole blood-, and lithium whole blood iohexol samples.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"339-343"},"PeriodicalIF":1.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875483/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363537","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":"Patient-centric clinical trials: collaboration and innovation in bioanalytical and clinical operations.","authors":"Saloumeh K Fischer","doi":"10.1080/17576180.2025.2458453","DOIUrl":"10.1080/17576180.2025.2458453","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"277-280"},"PeriodicalIF":1.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864313/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063536","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":"Recent advances in fluorescent gold nanocluster-based bioanalytical analysis and imaging in living cell.","authors":"Hanbing Ge, Longhui Zhan, Hao Chen, Ruibo Lv, Yanbo Wen, Mingxiang Chen, Fengniu Lu, Zhiqin Yuan","doi":"10.1080/17576180.2025.2457853","DOIUrl":"10.1080/17576180.2025.2457853","url":null,"abstract":"<p><p>Ultrasmall and highly fluorescent gold nanoclusters (Au NCs) have been widely used for the construction of sensing and imaging platforms. Specifically, through a combination of surface functionalization and spectral analysis and/or imaging techniques, effective intracellular detection and imaging are realized. In this review, we summarize the recently adopted intracellular analysis and imaging events with Au NCs-based probes. The synthesis of Au NCs is briefly introduced based on stabilizer selection. The principles and applications of fluorometric intracellular detection systems toward different analytes, including small molecules and biomacromolecules, are presented by turnoff, turn-on, and ratiometric tactics. The cell imaging events are summarized based on conventional imaging and high-resolution imaging techniques, respectively. In the end, this review highlights the challenges of intracellular applications with Au NCs.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"199-210"},"PeriodicalIF":1.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11853653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063537","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":"Simultaneous quantification of siRNA antisense and sense strands by hybrid liquid chromatography-mass spectrometry.","authors":"Karan Agrawal, Shaofei Ji, Wenying Jian","doi":"10.1080/17576180.2025.2457894","DOIUrl":"10.1080/17576180.2025.2457894","url":null,"abstract":"<p><strong>Background: </strong>Most oligonucleotide bioanalytical assays currently only quantify the pharmacologically-active antisense strand, though there have been recent efforts to simultaneously quantify the sense strand using hybridization ELISA or solid phase extraction LC-MS. Hybrid LC-MS, which offers both high sensitivity and specificity unlike the currently used platforms, has not been applied to quantify both siRNA strands simultaneously.</p><p><strong>Materials & methods: </strong>A hybrid LC-MS assay utilizing LNA capture probes was developed and applied to quantify both strands of a 21-mer lipid-conjugated siRNA (SIR-3) using tandem mass spectrometry (MS/MS). A similar approach using high-resolution mass spectrometry (HRMS) was also evaluated.</p><p><strong>Results: </strong>The final LC-MS/MS method was capable of quantifying both strands of SIR-3 at concentrations between 0.600 and 1000 ng/mL in cynomolgus monkey tissue homogenates with acceptable accuracy and precision. The LC-HRMS assay demonstrated similar sensitivity and assay performance as the LC-MS/MS assay.</p><p><strong>Conclusions: </strong>Overall, this manuscript presents orthogonal methods to existing siRNA bioanalytical workflows that with high sensitivity and specificity can provide greater information about the concentration and biotransformation of an siRNA analyte.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"249-259"},"PeriodicalIF":1.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11864311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143063538","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: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (<u>PART 2A</u> - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) <u>PART 2B</u> - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).","authors":"Nicoletta Bivi, Danielle Graham, Laura Joglekar, Kristina McGuire, Jeroen Stoop, Jad Zoghbi, Brian Baker, Abbas Bandukwala, Sarah Bond, Alessandra Buoninfante, Jeff Chen, Mark Dysinger, Jörg Engelbergs, Michele Fiscella, Fabio Garofolo, Shirley Hopper, Barry Jones, Lindsay King, Rocio Murphy, Rachel Palmer, Gerard Sanderink, Agnes Seyda, Huaping Tang, Andrea Van Tuyl, Leslie Wagner, Karl Walravens, Kai Wang, Hilke Zander, Liang Zhu, Ming Li, Yi-Dong Lin, Mahwish Natalia, Nathan Standifer, Steven Eck, Polina Goihberg, Katharine Grugan, Michael Nathan Hedrick, Greg Hopkins, Sumit Kar, Steve Keller, Shannon McGrath, Bill O'Gorman, Chad Stevens, Erin Stevens, Grzegorz Terszowski, Paul C Trampont, Shuyu Yao, Alison Joyce, Seema Kumar, Carolina Owen, Samuel Pine, Graham Yearwood, Liching Cao, Valerie Clausen, Kelly Coble, Andria Culbert, Shalini Gupta, Richard Hughes, Susana Liu, Kun Lu, Rita Martello, Kimberly J Reese, Kay-Gunnar Stubenrauch, Yi Wen","doi":"10.1080/17576180.2024.2442218","DOIUrl":"10.1080/17576180.2024.2442218","url":null,"abstract":"<p><p>The 18th Workshop on Recent Issues in Bioanalysis (18th 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 18th 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 18th 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 2) covers in the Part 2A the recommendations on Biomarkers/BAV, IVD/CDx, LBA and Cell-Based Assays and in Part 2B the Regulatory Inputs on these topics. Part 1 (Mass Spectrometry Assays and Regulated Bioanalysis/BMV) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 17 of Bioanalysis, issues 5 and 3 (2025), respectively.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"211-248"},"PeriodicalIF":1.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866642/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143036236","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}