Bioanalysis最新文献_第6页

Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum. 欧洲生物分析论坛最近关于挑战三级免疫原性测试策略的讨论和建议。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-04-09 DOI: 10.1080/17576180.2025.2487377

Kyra J Cowan, Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale, Birgit Jaitner, Peter van Bommel, Saskia van der Lee, Michaela Golob, Rob Nelson, Philip Timmerman

{"title":"Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum.","authors":"Kyra J Cowan, Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale, Birgit Jaitner, Peter van Bommel, Saskia van der Lee, Michaela Golob, Rob Nelson, Philip Timmerman","doi":"10.1080/17576180.2025.2487377","DOIUrl":"10.1080/17576180.2025.2487377","url":null,"abstract":"The European Bioanalysis Forum, in discussions with cross-industry experts from pharmaceutical, biotech, and contract research organizations, is continuing the challenge of the traditional 3-Tier immunogenicity testing strategy, proposing a simpler, context-driven 1-Tier approach, a recent paradigm shift that emphasizes clinical relevance and the impact of anti-drug antibodies over mere incidence. In a workshop at the 17th annual Open Symposium, the meeting highlighted using signal-to-noise ratios to assess low-level ADA responses and addressed challenges such as nonspecific binding and assay reliability. Participants debated the need for continued confirmatory testing, and that it should be performed on a case-by-case basis. The shift aims to improve clinical testing strategies while reducing complexity, promoting data-driven decisions. Case studies, particularly from high-risk molecules, will guide implementation. Overall, there's strong support for the 1-Tier approach, but its success depends on robust data, industry collaboration, and regulatory approval.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"575-578"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12128674/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810413","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

Integrating metering capabilities to increase the utility of self-collected, dried samples. 集成计量功能，以增加自收集，干燥样品的效用。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-07 DOI: 10.1080/17576180.2025.2501927

Amanda Code, Brandon T Johnson, Charles R Mace

引用次数: 0

Determination of drugs of abuse in oral fluid using dried oral fluid spot assisted by 24-well plate and LC-MS/MS. 24孔板辅助干口服液斑法和LC-MS/MS法测定口服液中滥用药物。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-22 DOI: 10.1080/17576180.2025.2506348

Gabriela Ramos Borges, Bruno Pereira Dos Santos, Giovanna Cristiano de Gouveia, Carolina Silveira Dalanhol, Juliana Nichterwitz Scherer, Sarah Eller, Tiago Franco de Oliveira

{"title":"Determination of drugs of abuse in oral fluid using dried oral fluid spot assisted by 24-well plate and LC-MS/MS.","authors":"Gabriela Ramos Borges, Bruno Pereira Dos Santos, Giovanna Cristiano de Gouveia, Carolina Silveira Dalanhol, Juliana Nichterwitz Scherer, Sarah Eller, Tiago Franco de Oliveira","doi":"10.1080/17576180.2025.2506348","DOIUrl":"10.1080/17576180.2025.2506348","url":null,"abstract":"Background: Oral fluid has proven to be an excellent matrix for drug testing. Several analytical techniques are available, including the use of dried spots, which have gained increasing recognition in recent years. In this study, a new method was developed and validated using dried oral fluid spot (DOFS) assisted by a 24-well plate for the simultaneous determination of thirteen drugs of abuse and metabolites in oral fluid by LC - MS/MS.Methods: Samples were collected by expectoration and diluted with water. A 100 μL aliquot of sample was applied onto the spot, dried for 60 min, and extracted with 250 μL of acetonitrile:methanol (3:1). The method was validated according to the ANSI/ASB Standard 036 guideline, and 86 oral fluid samples were analyzed.Results: The limits of quantification ranged from 1 to 5 ng/mL, and all calibration curves were linear. Precisions ranged from 2.0 to 13.0% and Bias fluctuated from -19.7 to 9.6%. Ionization suppression or enhancement was noted at -16.2 to 16.6%. Among the analyzed samples, 86% tested positive for at least one substance.Conclusions: The findings confirm that the proposed method was successfully validated, providing a new bioanalytical approach for the detection of drugs of abuse in oral fluid.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"17 9","pages":"595-605"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12118403/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118680","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

Mass spectrometry-based methods for biofluid biomarkers for progressive diseases: amyloid peptides and dystrophins. 基于质谱的进行性疾病生物流体标志物的方法：淀粉样肽和营养不良蛋白。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-06-04 DOI: 10.1080/17576180.2025.2515011

Makoto Niwa, Kenta Noda, Yoshiyuki Kobayashi, Itsuki Kageyama, Kota Kodama

{"title":"Mass spectrometry-based methods for biofluid biomarkers for progressive diseases: amyloid peptides and dystrophins.","authors":"Makoto Niwa, Kenta Noda, Yoshiyuki Kobayashi, Itsuki Kageyama, Kota Kodama","doi":"10.1080/17576180.2025.2515011","DOIUrl":"10.1080/17576180.2025.2515011","url":null,"abstract":"Purpose: Using two diseases, Alzheimer's disease and muscular dystrophy as examples, in which many resources have been invested, trends in bioanalytical techniques for detection of peptide or protein biomarkers using mass spectrometry are reviewed using Web of Science database. Amyloid beta peptides have been used to detect Alzheimer's disease, and peptides obtained by tryptic digestion of dystrophin have been used to detect muscular dystrophy. Based on the recent interest in peripheral blood analysis, literature review was focused on biofluid analysis.Results: Both electrospray or matrix-assisted laser desorption ionization mass spectrometry were employed for amyloid beta peptides, and high-resolution or ion mobility techniques had been introduced to enhance selectivity. Immunoprecipitation techniques were often used for pretreatment; however, emergence of combined use of different solid-phase extraction mode was observed. Regarding tryptic peptides obtained from dystrophin, there are few reported applications in biofluids, and typically electrospray ionization-selected reaction monitoring with pretreatment using solid-phase extraction were employed.Implications: Validity of blood biomarkers propelled development of bioanalytical methods by attracting research interest. The analytical methodologies was built on proven methods in the field of peptide analysis, and current interests were in techniques increasing selectivity and sensitivity, such as differential mobility spectrometry or parallel reaction monitoring.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"671-680"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12160601/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214792","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

Design of experiments for the optimization of sample preparation for bottom-up targeted protein LC-MS/MS workflows. 优化自下而上靶向蛋白LC-MS/MS工作流程制备样品的实验设计。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-06-10 DOI: 10.1080/17576180.2025.2515004

Szabolcs Szarka, Margret Thorsteinsdottir, Robert Wheller

{"title":"Design of experiments for the optimization of sample preparation for bottom-up targeted protein LC-MS/MS workflows.","authors":"Szabolcs Szarka, Margret Thorsteinsdottir, Robert Wheller","doi":"10.1080/17576180.2025.2515004","DOIUrl":"10.1080/17576180.2025.2515004","url":null,"abstract":"Aims: Design of experiments (DOE) is a versatile and efficient approach to tackle complex scientific problems. We aimed to assess its feasibility in the optimization of the multistep, involved bottom-up sample preparation for the UPLC-MS/MS analysis of proteins.Materials and methods: The model analyte was a human IgG1 monoclonal antibody which was spiked into rat plasma and processed further by reduction, alkylation, and digestion for the subsequent UPLC-MS/MS analysis. The Modde Go software was used for the generation of experimental designs and for processing, analyzing and the interpretation of the data.Results: DOE screening revealed that urea made the biggest improvement on the surrogate peptide responses, while guanidine significantly suppressed them. DOE optimization resulted in a 2-, 10-, 10- and 50-fold response increase for the respective DTLM, FNWY, TPEV and VVSV surrogate peptide even after a short, <3-h sample preparation, when compared to a legacy method that required 2-day preparation.Conclusions: The DOE approach was applied successfully for the comprehensive optimization of eight denaturation, reduction and digestion parameters. DOE was found to be an efficient tool for protein sample preparation optimization, and the predictive power of the DOE models was successfully demonstrated.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"641-650"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12160604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257225","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

Assessing linearity of vaccine immunogenicity assays: application and link with clinical endpoints. 评估疫苗免疫原性测定的线性：应用和与临床终点的联系。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-13 DOI: 10.1080/17576180.2025.2501934

Capucine Lepers, Aurélie Bellanger, Oana Petrof, Martin Verniquet, Mikaël Le Bouter, Cédric Taverne

{"title":"Assessing linearity of vaccine immunogenicity assays: application and link with clinical endpoints.","authors":"Capucine Lepers, Aurélie Bellanger, Oana Petrof, Martin Verniquet, Mikaël Le Bouter, Cédric Taverne","doi":"10.1080/17576180.2025.2501934","DOIUrl":"10.1080/17576180.2025.2501934","url":null,"abstract":"Assessing the performance of an immunogenicity assay before using it to support vaccine clinical trials is mandatory. Further validation of assay performance is even requested to support Phase III studies. While assay validation requires adherence to predefined acceptance criteria, there is no universal stringency level for earlier phases of assay development. Setting scientifically sound criteria for success is about finding the right balance between unavoidable assay limitations and ensuring the assay is fit-for-purpose. In this paper, we focus on the evaluation of linearity for immunogenicity assays and its use as surrogate for accuracy evaluation in the absence of reference material. We propose a simple method for evaluating assay linearity and understanding the impact of a linearity deviation on the evaluation of the response increase in clinical trial. Assessment is reliable in absence of known concentration samples, unlike methods in industry guidance, making the proposed method more versatile. Method is illustrated by two case studies, representative of the assays used in the vaccine field. Making the link between assay linearity and clinical endpoints provides a simple and clear framework to support the definition of assay validation criteria, applicable to a variety of immunogenicity assays.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"583-594"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12118427/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960557","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

Validated GC-MS methods to detect ethylene, diethylene, and triethylene glycol in serum, plasma, and urine samples. 验证气相色谱-质谱法检测血清、血浆和尿液样本中的乙烯、二乙烯和三甘醇。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-22 DOI: 10.1080/17576180.2025.2506352

Nicolas Abrigo, Susan Daniela Selaya, Adil Mohammad, Diaa Shakleya, Dustin G Brown, Jinhui Zhang, Valerie Pratt, Jody E Green, Amanda Degunia, Michael Bennett, Kaitlyn Bloom, Lynnette Rogers, Aiman Q Khan, Robert O Heuckeroth, Patrick J Faustino

{"title":"Validated GC-MS methods to detect ethylene, diethylene, and triethylene glycol in serum, plasma, and urine samples.","authors":"Nicolas Abrigo, Susan Daniela Selaya, Adil Mohammad, Diaa Shakleya, Dustin G Brown, Jinhui Zhang, Valerie Pratt, Jody E Green, Amanda Degunia, Michael Bennett, Kaitlyn Bloom, Lynnette Rogers, Aiman Q Khan, Robert O Heuckeroth, Patrick J Faustino","doi":"10.1080/17576180.2025.2506352","DOIUrl":"10.1080/17576180.2025.2506352","url":null,"abstract":"Background: While Polyethylene glycol 3350 (PEG 3350) is approved by the USFDA for short term use by adults, it is commonly recommended for use in constipated children. Multiple reports of adverse events in children taking PEG 3350 raised safety concerns suggesting that low molecular weight species of PEG 3350 might be absorbed from the gut and cause side effects such as ethylene glycol (EG), diethylene glycol (DEG), and triethylene glycol (TEG).Research design and methods: This article documents the development, validation, and application of analytical methods using GC-MS and GC-MS/MS for the quantitation of EG, DEG, and TEG in human plasma, serum, and urine.Results: The analytical range for EG, DEG, and TEG was 2-20 µg/mL. The sample preparation process involves derivatization using N,O-bis(trimethylsilyl) trifluoroacetamide with 1% trimethylchlorosilane in each biological matrices. Deuterated internal standards for each of the analytes were included to provide accurate quantitation of the glycol analytes.Conclusions: The validated methods were applied to analyze samples a pilot study of children taking PEG 3350. DEG and TEG were detected at levels below the limit of quantitation. In summary, a platform of analytical methods was developed to evaluate glycol analogs in urine, serum, and plasma clinical samples.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"651-660"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12160607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118679","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 rapid and sensitive UHPLC-MS/MS method for epalrestat detection in micro-volumes of human plasma for the first time. 首次建立了快速、灵敏的UHPLC-MS/MS检测人血浆中依帕司他的方法。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-26 DOI: 10.1080/17576180.2025.2509480

Hong Chen, Kewei Liu, Jiawen Zhang, Xihong Zhao, Yatian Wang, Xiumei Lu, Feng Qin

{"title":"A rapid and sensitive UHPLC-MS/MS method for epalrestat detection in micro-volumes of human plasma for the first time.","authors":"Hong Chen, Kewei Liu, Jiawen Zhang, Xihong Zhao, Yatian Wang, Xiumei Lu, Feng Qin","doi":"10.1080/17576180.2025.2509480","DOIUrl":"10.1080/17576180.2025.2509480","url":null,"abstract":"Aim: A rapid and sensitive ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method was developed and validated for epalrestat detection in human plasma.Materials and methods: A triple quadrupole tandem mass spectrometer equipped with an electrospray ionization (ESI) source was used to quantify epalrestat and the internal standard epalrestat-d5 in the negative ion mode using multiple reaction monitoring (MRM). After acetonitrile-mediated protein precipitation, chromatographic separation was achieved using a reversed-phase C18 column (ACQUITY UPLC BEH, 2.1 × 50 mm, 1.7 μm; Waters Corp) with acetonitrile and 2 mM ammonium acetate in water as the mobile phase through gradient elution.Results and conclusion: The retention time of epalrestat was 0.92 min and the entire run time was only 2.00 min. The calibration curve was linear in the range 10.0-8.00 × 103 ng/mL (r ≥ 0.99). The within-run and between-run relative standard deviations (RSDs) were < 9.3%. The within-run and between-run relative errors (REs) ranged -8.4-4.2%. No significant matrix effects were observed and the recovery rate was high. The method was fully validated, including reinjection reproducibility in human plasma, and was successfully applied in a pharmacokinetic study, in which 100% incurred sample reanalysis met the criteria.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"629-639"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12160602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144148994","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

LC-MS/MS determination of trazodone in human plasma and its pharmacokinetic study in healthy Chinese. 人血浆中曲唑酮的LC-MS/MS测定及其在健康人群中的药动学研究。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-15 DOI: 10.1080/17576180.2025.2506349

Kaiwei Luo, Danrui Liu, Shengshuo Zhang, Xin Zhang, Qunan Cheng, Jie Lin, Yonghua Yu

引用次数: 0

Validation of UV-Vis spectrophotometric colorimetric methods for Rifampicin quantification in PBS & biological matrices. 紫外-可见分光光度比色法在PBS和生物基质中定量利福平的验证。

IF 1.9 4区医学

Bioanalysis Pub Date : 2025-05-01 Epub Date: 2025-05-14 DOI: 10.1080/17576180.2025.2501942

Elma Ninta Br Ginting, Giovanni Valerio Lembang, Dian Arnita Putri Abdullah, Siti Sri Rejeki Nurrakhma, Muh Rayhan Iskandar Ridwan, Andi Dian Permana

{"title":"Validation of UV-Vis spectrophotometric colorimetric methods for Rifampicin quantification in PBS & biological matrices.","authors":"Elma Ninta Br Ginting, Giovanni Valerio Lembang, Dian Arnita Putri Abdullah, Siti Sri Rejeki Nurrakhma, Muh Rayhan Iskandar Ridwan, Andi Dian Permana","doi":"10.1080/17576180.2025.2501942","DOIUrl":"10.1080/17576180.2025.2501942","url":null,"abstract":"Background: Rifampicin (RIF) is the main treatment for tuberculous meningitis (TBM), but its limited penetration across the blood-brain barrier significantly reduces its therapeutic efficacy. To address this limitation, smart-pH nanoparticles were designed to release RIF in inflamed area and incorperated into a thermosensitive in situ gel for enhanced drug delivery via the olfactory nerve.Methods: UV-Vis spectrophotometry and colorimetric methods to quantify RIF in various media and biological matrices, including phosphate-buffered saline (PBS) at pH 7.4 and 5.0, plasma, and brain tissue. The main validation parameters assessed were selectivity, specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, extraction recovery, and dilution integrity.Result: Method validation followed International Council for Harmonization (ICH) guidelines, demonstrating excellent linearity (r2 = 0.999) and lower limit detection (LOD) of approximately 0,25-0.49 μg/mL were achieved in all media. The method demonstrated high accuracy (%RE -11.62% to 14.88%) and precision (%RSD 2.06% to 13.29%), meeting regulatory requirements.Conclusion: This validated approach enables reliable RIF quantification in biological samples, supporting its application in in vitro release studies, ex vivo permeability studies, and in vivo pharmacokinetic evaluations. These findings contribute to the advancement of targeted drug delivery systems for TBM treatment.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"607-620"},"PeriodicalIF":1.9,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12118395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976993","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