Bioanalysis最新文献_第2页

Mass spectrometry for clinical bioanalysis without chromatographic separation: bioequivalence for bupropion and its metabolites. 无色谱分离的临床生物分析质谱法：安非他酮及其代谢物的生物等效性。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-09-05 DOI: 10.1080/17576180.2025.2557187

Jinhui Zhang, Patrick J Faustino

{"title":"Mass spectrometry for clinical bioanalysis without chromatographic separation: bioequivalence for bupropion and its metabolites.","authors":"Jinhui Zhang, Patrick J Faustino","doi":"10.1080/17576180.2025.2557187","DOIUrl":"https://doi.org/10.1080/17576180.2025.2557187","url":null,"abstract":"Background: High-throughput solid-phase extraction coupled with tandem mass spectrometry (HT-SPE-MS/MS) is an automated sample delivery system to mass spectrometry that operates without chromatographic separation. The typical analysis time per sample using this platform is 10-30 s. While the HT-SPE-MS/MS system has demonstrated efficacy for in vitro assays, its application to the analysis of biological samples from in vivo bioavailability and bioequivalence studies presents challenges due to the complexity of the sample matrix. Three critical issues - matrix effect, specificity, and carryover - have not been thoroughly evaluated in complex biological matrices such as plasma.Research design and methods: This study assessed the feasibility of utilizing HT-SPE-MS/MS for the analysis of three metabolically related compounds (bupropion, hydroxybupropion, and threobupropion) in human plasma samples from a clinical bioequivalence study. Critical bioanalytical parameters, including matrix effect, specificity, accuracy, precision, and carryover, were systematically investigated.Results: These methods were subsequently applied to a bioequivalence study of bupropion. The HT-SPE-MS/MS approach achieved comparable accuracy, precision, linearity, and sensitivity to conventional ultra-performance liquid chromatography-mass spectrometry (UPLC-MS) methods, while offering 20- to 30-fold higher analysis speeds.Conclusion: The results of this study indicate that the HT-SPE-MS/MS system shows potential for high-throughput in vivo bioanalysis, particularly in bioavailability and bioequivalence studies.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-11"},"PeriodicalIF":1.8,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999508","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

Overcoming bioanalytical challenges during the development of risdiplam for the treatment of spinal muscular atrophy. 克服生物分析方面的挑战，在开发利斯地普兰治疗脊髓性肌萎缩症。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-09-04 DOI: 10.1080/17576180.2025.2554563

Katja Heinig, Pawel Dzygiel, Luca Ferrari

{"title":"Overcoming bioanalytical challenges during the development of risdiplam for the treatment of spinal muscular atrophy.","authors":"Katja Heinig, Pawel Dzygiel, Luca Ferrari","doi":"10.1080/17576180.2025.2554563","DOIUrl":"https://doi.org/10.1080/17576180.2025.2554563","url":null,"abstract":"Aims: Risdiplam is a small molecule approved for the treatment of spinal muscular atrophy (SMA). The drug and its major metabolite had to be measured in plasma and tissue from several animal species and in human plasma and urine. Bioanalytical challenges including light sensitivity, instability, carryover, nonspecific binding, and complex tissue analysis, had to be overcome.Materials & methods: Liquid chromatography tandem mass spectrometry with reversed-phase separation after protein precipitation/dilution was applied. Ascorbic acid was used as a stabilizer to mitigate degradation of the metabolite, and a surfactant additive prevented nonspecific binding in urine. Tissues were efficiently homogenized by bead beating and matrix-matched with plasma.Results and conclusions: The above challenges were successfully addressed with bioanalytical methods tailored to study needs. Validations and regulatory analyses met requirements of current guidelines, including successful incurred sample reanalysis (ISR) in GLP and clinical studies. The 3R principles (Replacement, Reduction, Refinement) were applied in animal studies to minimize the use of real matrices. Pediatric studies were supported with rapid analysis and microsampling. Bioanalysis supported patient-centric approaches in dose finding and sampling and was key in answering important questions to enable risdiplam to the market.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-13"},"PeriodicalIF":1.8,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144991317","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

Pharmacokinetic-pharmacodynamic and tissue distribution studies in physiological and cerebral ischemia-reperfusion injury rats after oral administration of anisodine hydrobromide tablets. 口服氢溴化山莨菪片对大鼠生理及脑缺血再灌注损伤的药动学-药效学及组织分布研究。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-30 DOI: 10.1080/17576180.2025.2554567

Yujie Yu, Yanfang Liu, Jianlan Zhang, Shu Dai, Rui Wu, Feng Wan, Chenhao Yao, Yuxin Yao, Feng Nan, Yunxia Li

引用次数: 0

Evaluating the efficacy of the VAMS Mitra microsampler for whole blood trace element analysis. 评价VAMS Mitra微采样器用于全血微量元素分析的有效性。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-22 DOI: 10.1080/17576180.2025.2549239

Oludesola Ogunesan, Christa Dahman Zaborske, Cassandra Newsom, Martin M Shafer, Kristina M Zierold, Jeffrey K Wickliffe

{"title":"Evaluating the efficacy of the VAMS Mitra microsampler for whole blood trace element analysis.","authors":"Oludesola Ogunesan, Christa Dahman Zaborske, Cassandra Newsom, Martin M Shafer, Kristina M Zierold, Jeffrey K Wickliffe","doi":"10.1080/17576180.2025.2549239","DOIUrl":"https://doi.org/10.1080/17576180.2025.2549239","url":null,"abstract":"Background: Volumetric Absorptive Microsampling (VAMS) is a blood sample collection method proposed as an alternative to venipuncture for metals/elements biomonitoring. However, the microsampler background concentration of metals and small blood volume remains critical limitations, particularly for metals or trace element analysis in environmental health and epidemiological research.Materials & methods: Trace element analysis was performed to measure metal concentration in blood samples collected via VAMS and venipuncture using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). VAMS blanks showed elevated background concentration, and cleaning was attempted using a multi-step cleaning protocol. Detection limits and efficacy of background concentration reduction were evaluated.Results: Initial analysis showed elevated background metal concentrations in the VAMS blank samplers, at or exceeding levels found in venous blood samples. VAMS blank with background concentration post-cleaning result indicated reductions in concentration for some metals; however, the concentration for most detected metals remained persistent.Conclusions: The efficacy of VAMS in environmental health and epidemiological biomarker research demonstrates both the promising potential and limitations, and the effectiveness of a rigorous cleaning protocol in reducing or eliminating background metal concentrations on microsampler tips.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1-8"},"PeriodicalIF":1.8,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939727","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

Bioanalysis for PK for antibody drug conjugates using ligand binding assay-challenges and bioanalytical strategies. 利用配体结合法对抗体药物偶联物进行PK生物分析-挑战和生物分析策略。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-19 DOI: 10.1080/17576180.2025.2548193

Xiaonan Liu, Tao Xu, Nan Zhang, John Zhongping Lin

{"title":"Bioanalysis for PK for antibody drug conjugates using ligand binding assay-challenges and bioanalytical strategies.","authors":"Xiaonan Liu, Tao Xu, Nan Zhang, John Zhongping Lin","doi":"10.1080/17576180.2025.2548193","DOIUrl":"10.1080/17576180.2025.2548193","url":null,"abstract":"Antibody-drug conjugates (ADCs) represent a rapidly advancing class of biotherapeutics for oncology and immunological indications. Comprehensive pharmacokinetic (PK) characterization is critical for assessing ADCs efficacy, safety, and overall therapeutic performance. Ligand binding assays (LBAs) are widely employed in both academic and industrial settings for the quantitative and semi-quantitative analysis of biologics. These assays rely on specific molecular interactions - commonly between antigens and antibodies or ligands and receptors - and offer high sensitivity, robustness, and cost-efficiency. In ADC bioanalysis, LBAs are utilized to quantify multiple types of analytes, including total antibody and antibody-drug conjugate. However, the development of LBA methods for ADCs is challenged by the structural heterogeneity of these molecules, analyte instability, and the need for high selectivity and sensitivity. This review summarizes the application of LBAs in ADC PK studies, outlines common methodological challenges, and discusses strategic considerations for assay development to ensure accurate and reliable bioanalytical measurements.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1057-1065"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12416172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144881972","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

How microsampling is impacting pharmacokinetic and toxicokinetic studies: volumetric absorptive microsampling (VAMS). 微采样如何影响药代动力学和毒代动力学研究：体积吸收微采样（VAMS）。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-25 DOI: 10.1080/17576180.2025.2546782

Michele Protti, Roberto Mandrioli, Hugo M Santos, Carlos Lodeiro, José L Capelo-Martínez, Laura Mercolini

引用次数: 0

Evolving bioanalytical strategies in the wake of pioneering biotherapeutics. 在开拓性生物治疗之后不断发展的生物分析策略。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-19 DOI: 10.1080/17576180.2025.2546775

Federico Riccardi Sirtori, Andrea Di Ianni, Claudio Crosasso, Elisa Bertotti, Francesco Molinaro, Ilse De Salve, Luca Barbero, Kyra J Cowan

{"title":"Evolving bioanalytical strategies in the wake of pioneering biotherapeutics.","authors":"Federico Riccardi Sirtori, Andrea Di Ianni, Claudio Crosasso, Elisa Bertotti, Francesco Molinaro, Ilse De Salve, Luca Barbero, Kyra J Cowan","doi":"10.1080/17576180.2025.2546775","DOIUrl":"10.1080/17576180.2025.2546775","url":null,"abstract":"The development of biotherapeutics, particularly multi-domain biotherapeutics (MDBs) and antibody drug conjugates (ADCs), presents unique challenges due to their complexity and increased immunogenicity risks. Bioanalytical approaches play a pivotal role in addressing these challenges. Robust bioanalytical methods are essential for effectively assessing the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenic responses of novel biologics. Advanced techniques, such as multiplexed assays using ligand binding assays (LBAs) and Liquid Chromatography-Mass Spectrometry (LC-MS) methods, are employed to handle the complexity of MDBs and ADCs effectively. Additionally, high-resolution mass spectrometry can investigate the potential biotransformation of biologics directly in in vivo studies. Furthermore, the Context of Use (CoU) is critical for defining assay purposes across nonclinical and clinical settings, ensuring their relevance and efficiency. Regulatory compliance is paramount to ensure assays meet standards for drug approval. Practical considerations include assay sensitivity, specificity, and the method's ability to investigate the structural integrity of MDBs and ADCs in in vivo studies. This paper aims to review recent publications on the application of bioanalytical techniques, specifically LBA and LC-MS, in supporting the development of pioneering biotherapeutics. Additionally, it will discuss optimal strategies for bioanalytical methods and immunogenicity assessment.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"979-996"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871203","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

Examining hybridization-based LC-MS methodologies for the bioanalysis of siRNA analytes. 研究基于杂交的LC-MS方法用于siRNA分析物的生物分析。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-25 DOI: 10.1080/17576180.2025.2548194

Karan Agrawal, Wenying Jian, Long Yuan

{"title":"Examining hybridization-based LC-MS methodologies for the bioanalysis of siRNA analytes.","authors":"Karan Agrawal, Wenying Jian, Long Yuan","doi":"10.1080/17576180.2025.2548194","DOIUrl":"10.1080/17576180.2025.2548194","url":null,"abstract":"Hybridization-based LC-MS is rapidly emerging as a bioanalytical platform for oligonucleotides, particularly when both high sensitivity and high specificity are needed. When used to analyze single-stranded antisense oligonucleotide (ASO) therapeutics, the workflows are relatively well established, but the analysis of double-stranded small interfering RNA (siRNA) therapeutics presents additional challenges due to competition for binding from the sense strand. In the last two years, the authors have independently published extensively on hybridization-based LC-MS bioanalysis of siRNA therapeutics, and now we take a step back to evaluate the progress we have made and offer our thoughts on the future of this platform. We touch upon aspects of the sample preparation and analytical process that can either be improved upon, made more efficient, or expanded to maximize the information that can be gained from a single sample. Additionally, we discuss how hybridization-based LC-MS compares to other common oligonucleotide bioanalytical workflows, and its potential to become a frontline assay platform for use in supporting regulatory submissions. Overall, we are excited about the potential hybridization-based LC-MS has demonstrated as a bioanalytical platform and are eager to begin the conversation on where this workflow goes next.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1041-1055"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12416169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144940475","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

HPPA as assay substrate for improved capturing of sample variability during cut point analyses in immunogenicity testing. 在免疫原性测试中，HPPA作为检测底物，用于改进在切割点分析中捕获样品变异性。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-16 DOI: 10.1080/17576180.2025.2546773

Gregor Jordan, Alexander Pöhler, Cordula Jany, Thomas Bach, Roland F Staack

{"title":"HPPA as assay substrate for improved capturing of sample variability during cut point analyses in immunogenicity testing.","authors":"Gregor Jordan, Alexander Pöhler, Cordula Jany, Thomas Bach, Roland F Staack","doi":"10.1080/17576180.2025.2546773","DOIUrl":"10.1080/17576180.2025.2546773","url":null,"abstract":"Aims: Immunogenicity testing is a key component of protein drug development, with ADA bridging assays recognized as the gold standard method. These assays employ labeled therapeutic drugs for capture and detection, with the substrate playing a critical role in generating a detectable signal to differentiate the presence of anti-drug antibodies (ADAs) from nonspecific binding. This study investigates the impact of substrate choice on the assay's ability to capture individual sample variability, focusing on screening and confirmatory cut points (SCP and CCP).Methods: We compared the colorimetric substrate 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS) with the fluorescent substrate 3-(4-hydroxyphenyl)propionic acid (HPPA) in ELISA-based ADA bridging assays for two monoclonal antibodies.Results: Switching the substrate from ABTS to HPPA improved the differentiation of individual signals from baseline noise, enabling a more robust ADA identification. Additionally, the use of HPPA resulted in higher SCP and CCP values. Further investigation revealed that technical reader noise affected a normally distributed sample set when using ABTS.Conclusion: The substrate switch, while maintaining all other assay parameters, proved to be a convenient approach to increase SCP and CCP while improving the ability to capture individual sample variability.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"951-958"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413051/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858808","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

Ultra-high throughput mass spectrometry with ultra high-speed separations: differential mobility spectrometry-acoustic ejection mass spectrometry (DAEMS). 超高通量质谱与超高速分离：差分迁移率光谱-声弹射质谱（DAEMS）。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-14 DOI: 10.1080/17576180.2025.2546780

Samad Bazargan, Chang Liu, Bradley B Schneider, Thomas R Covey

{"title":"Ultra-high throughput mass spectrometry with ultra high-speed separations: differential mobility spectrometry-acoustic ejection mass spectrometry (DAEMS).","authors":"Samad Bazargan, Chang Liu, Bradley B Schneider, Thomas R Covey","doi":"10.1080/17576180.2025.2546780","DOIUrl":"10.1080/17576180.2025.2546780","url":null,"abstract":"With the ongoing advancements in the field of ambient ionization for mass spectrometry, systems with a high-throughput capability on the order of 1 sample/second are readily available. This has led to the adoption of mass spectrometry for a wide variety of applications including those in the drug discovery process. Mass spectrometers have traditionally relied on pre-separation technologies such as high-pressure liquid chromatography for sample clean-up and isobaric separations, but such techniques are not high-throughput compatible. Differential mobility spectrometry is a high-speed atmospheric separation device with separations orthogonal to m/z that can be coupled with the high-throughput sample introduction devices such as acoustic ejection mass spectrometer to address this gap. In this article we highlight the significance of the recent reports on this topic and provide some insights into expanding the use of this technique for new applications. We believe this is a promising new development and will help propel the high-throughput mass spectrometry beyond isobaric interferences.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"969-977"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144854378","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