Bioanalysis最新文献_第2页

Two-dimensional transition metal dichalcogenides for biosensing: synthesis strategies, material properties, and biomarker detection applications. 用于生物传感的二维过渡金属二硫族化合物：合成策略、材料特性和生物标志物检测应用。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-09-22 DOI: 10.1080/17576180.2026.2736388

Husam Abushar, Nur Dalila Rizuan, Subash C B Gopinath, Hanis Farhah Jamahori

{"title":"Two-dimensional transition metal dichalcogenides for biosensing: synthesis strategies, material properties, and biomarker detection applications.","authors":"Husam Abushar, Nur Dalila Rizuan, Subash C B Gopinath, Hanis Farhah Jamahori","doi":"10.1080/17576180.2026.2736388","DOIUrl":"10.1080/17576180.2026.2736388","url":null,"abstract":"Two-dimensional (2D) materials have attracted interest because of their unique physical, electronic, and optical characteristics. When thinned to a monolayer, several TMDs undergo an indirect-to-direct bandgap transition and exhibit exceptional optoelectronic characteristics. In contrast to graphene and other 2D materials, TMDs possess intrinsic bandgaps, phase-dependent conductivity, and chemically active edge sites, which facilitate efficient signal transduction and selective biomolecular interfacing. This review presents an overview of TMD-based biosensors, systematically correlating material properties and synthesis strategies with device performance and application relevance. Key fabrication approaches, including top-down exfoliation methods and bottom-up thin-film growth are critically discussed with respect to scalability, structural control, and reproducibility. As active sensing elements, TMDs enable real-time detection of individual biomarkers and demonstrate significant potential for point-of-care healthcare devices. This review further provides a technical overview of 2D TMD-based biosensors for the detection of biological targets employing optical, electrical, and electrochemical sensing mechanisms. In addition, current approaches, recent developments, key challenges, and future perspectives for healthcare device applications are discussed.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1131-1158"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015366","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-triple quadrupole-MS based quantitative analysis of tafenoquine in rat plasma and red blood cells: method development and validation. 基于lc -三重四极杆-质谱的大鼠血浆和红细胞中他非诺喹定量分析方法的建立和验证。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-09-24 DOI: 10.1080/17576180.2026.2737004

Akash Rajput, Jinal Ajabiya, Shweta Powar, Megha Pillai, Pinaki Sengupta

{"title":"LC-triple quadrupole-MS based quantitative analysis of tafenoquine in rat plasma and red blood cells: method development and validation.","authors":"Akash Rajput, Jinal Ajabiya, Shweta Powar, Megha Pillai, Pinaki Sengupta","doi":"10.1080/17576180.2026.2737004","DOIUrl":"10.1080/17576180.2026.2737004","url":null,"abstract":"Background: For antimalarial drugs such as Tafenoquine, which preferentially distribute within red blood cells (RBCs), plasma concentrations cannot accurately reflect intracellular drug levels available to exert the therapeutic effect.Methodology: This study aims to establish a sensitive bioanalytical method using LC-triple quadrupole-MS for the accurate quantification of Tafenoquine levels in red blood cells (RBCs) and plasma, addressing the lack of previously reported methods. A simple protocol for the isolation of a 99% pure RBC fraction, with minimal blood volume requirements, was also established to carry out this study. Across both the biological matrices, the assay represented a linear dynamic range of 0.5-800 ng/mL and a lower limit of quantification of 0.5 ng/mL.Results: Precision and accuracy for the developed method were found within the acceptable range of the ICH M10 guideline across both matrices for the entire calibration range. Matrix effect, recovery and stability studies also gave promising results for RBCs as well as the plasma matrix.Conclusion: The method will allow accurate evaluation of cellular-level pharmacokinetics, drug-drug interactions, and bioavailability of Tafenoquine, providing a strong foundation for antimalarial drug discovery research in a preclinical setup.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1083-1093"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149029791","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

Understanding Alzheimer's disease through biomarkers: pathology, progression, and clinical application. 通过生物标志物了解阿尔茨海默病：病理、进展和临床应用。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-09-30 DOI: 10.1080/17576180.2026.2740372

Xiaolong Tom Zhang, Michael Murphy, Henry Riordan, Kai Wang, Rianne Esquivel, Weifeng Xu, Xuefeng Zhang, Xinjiang Gong, Yunuo Sun, Yang Lu

{"title":"Understanding Alzheimer's disease through biomarkers: pathology, progression, and clinical application.","authors":"Xiaolong Tom Zhang, Michael Murphy, Henry Riordan, Kai Wang, Rianne Esquivel, Weifeng Xu, Xuefeng Zhang, Xinjiang Gong, Yunuo Sun, Yang Lu","doi":"10.1080/17576180.2026.2740372","DOIUrl":"10.1080/17576180.2026.2740372","url":null,"abstract":"Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide accounting for an estimated 60% to 80% of cases. Biomarkers play an integral role in AD randomized clinical trials (RCTs), providing objective measures of disease pathology, progression, and therapeutic efficacy. Key biomarkers, including amyloid-beta (Aβ), tau proteins, neuroinflammatory and neurodegeneration markers, as well as various neuroimaging modalities can help to facilitate the assessment of disease-modifying therapies, enable earlier detection of pathological changes before clinical symptoms emerge, and inform regulatory decision-making by demonstrating target engagement and possible treatment efficacy when linked to cognitive outcomes. This review examines the most salient biomarkers in AD RCTs and underlines their importance in advancing diagnostics, guiding therapeutic development, and improving clinical trial design to enable effective disease-modifying treatments. [Relevant literature was identified through searches of PubMed and Google Scholar for studies published through June 2026].","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"18 12-13","pages":"1197-1207"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644586/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103582","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

Development of a ready-to-use cell-based functional neutralizing antibody assay for MK-1484, a PEGylated IL-2 mutein that preferentially activates effector T-cells. 针对MK-1484（一种优先激活效应t细胞的聚乙二醇化IL-2突变蛋白）开发即用型细胞功能性中和抗体测定。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-09-06 DOI: 10.1080/17576180.2026.2728520

Dhanvanthri S Deevi, Aparna Swarup, Tatyana Yun, Federico Ferrari, Jennifer Nguyen, Chuying Ma, Nazneen Bano, James Schiller, Linlin Luo, Roy Helmy, Faye Vazvaei-Smith, Weifeng Xu

{"title":"Development of a ready-to-use cell-based functional neutralizing antibody assay for MK-1484, a PEGylated IL-2 mutein that preferentially activates effector T-cells.","authors":"Dhanvanthri S Deevi, Aparna Swarup, Tatyana Yun, Federico Ferrari, Jennifer Nguyen, Chuying Ma, Nazneen Bano, James Schiller, Linlin Luo, Roy Helmy, Faye Vazvaei-Smith, Weifeng Xu","doi":"10.1080/17576180.2026.2728520","DOIUrl":"10.1080/17576180.2026.2728520","url":null,"abstract":"Background: MK-1484 is an engineered, PEGylated interleukin-2 (IL-2) mutein that preferentially binds the βγ subunits of the IL-2 receptor to activate effector T-cells and natural killer (NK) cells. Owing to high sequence homology, anti-drug antibodies (ADAs), including neutralizing antibodies (NAbs), may cross-react with and neutralize endogenous IL-2; MK-1484 is therefore classified as having a high immunogenicity risk, requiring an NAb assay to be ready for early-phase clinical studies.Research design and methods: A highly sensitive competitive ligand-binding assay (cLBA) using mixed recombinant β- and γ-IL-2 receptor subunits was considered impractical, so plate- and flow cytometry-based cell-binding assays were attempted using the IL-2-dependent KIT225 cell line. A cell-based functional luciferase reporter assay (KIT225-STAT5-Luc#8) was then developed and qualified.Results: Both cell-binding assays produced only weak signal. The functional reporter assay was successfully developed and qualified as a ready-to-use format for MK-1484 (cut point S/N 0.62; sensitivity 4.0 µg/mL), overcoming cell-line instability, lengthy recovery, and IL-2 starvation by using MK-1484 itself for post-thaw recovery and reducing the workflow from ~6 to 2 days.Conclusions: The ready-to-use functional NAb assay is fit-for-purpose for early-phase testing when combined with a more sensitive wild-type IL-2 NAb assay as the primary safety screen, and may be adaptable to other IL-2-based biotherapeutics, subject to case-by-case evaluation.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1065-1074"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644639/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148900004","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 DAR sensitive hybrid LBA-LC-MS/MS assay for quantitation of conjugated payload from a non-cleavable ADC in human serum. 一种DAR敏感的混合LBA-LC-MS/MS方法用于定量人血清中不可切割ADC的共轭有效载荷。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-08-17 DOI: 10.1080/17576180.2026.2716471

Yongjun Xue, Eric Ma, Brian Melo, Madhan Masilamani, Yiming Cheng, Jim X Shen, M Shane Woolf, Korrey D Allen, Jordan M Honrine, Michael P Waldron, William R Mylott

{"title":"A DAR sensitive hybrid LBA-LC-MS/MS assay for quantitation of conjugated payload from a non-cleavable ADC in human serum.","authors":"Yongjun Xue, Eric Ma, Brian Melo, Madhan Masilamani, Yiming Cheng, Jim X Shen, M Shane Woolf, Korrey D Allen, Jordan M Honrine, Michael P Waldron, William R Mylott","doi":"10.1080/17576180.2026.2716471","DOIUrl":"10.1080/17576180.2026.2716471","url":null,"abstract":"Background: Quantitating antibody drug conjugates (ADCs) with traditional ligand binding assays (LBAs) requires cytotoxic payload targeting reagents, which may be needed for ADC capture/detection. LBAs are drug antibody ratio insensitive (DAR insensitive) and prone to under- or over-estimating DAR species.Methods: This hybrid LBA LC MS/MS assay measures concentrations for a novel ADC drug (BMS-X) with an engineered, site‑specific, non-cleavable linker, and a unique payload. Recombinant target protein-extracellular domain fused with mouse IgG-Fc was used for ADC pull down in human serum. Pepsin digestion released unique toxin linker peptide complexes for two conjugation sites.Results and conclusions: This novel, validated DAR-sensitive hybrid-LCMS PK assay measured payload-conjugated BMS-X levels in human serum, quantitated surrogate analytes for both unique conjugation sites, and was used to support a first-in-human clinical trial.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1041-1053"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644640/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148759641","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

Evaluation of volumetric DBS for lead analysis using ICP-MS/MS: addressing matrix effects and hematocrit variability. 利用ICP-MS/MS评价容量DBS用于铅分析：处理基质效应和红细胞压积变异性。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-09-10 DOI: 10.1080/17576180.2026.2728919

Halimat S Olaniyan, Joshua Kocemba, Gillian Coultas, John O Ogunbileje, Kavita Umrau, Michelle K Zimmerman, Rejwi A Dahal

{"title":"Evaluation of volumetric DBS for lead analysis using ICP-MS/MS: addressing matrix effects and hematocrit variability.","authors":"Halimat S Olaniyan, Joshua Kocemba, Gillian Coultas, John O Ogunbileje, Kavita Umrau, Michelle K Zimmerman, Rejwi A Dahal","doi":"10.1080/17576180.2026.2728919","DOIUrl":"10.1080/17576180.2026.2728919","url":null,"abstract":"Background: Lead testing in dried blood spots (DBS) offer a convenient alternative to venous blood draw; however, its adoption has been limited by variable extraction efficiency, matrix effects, and hematocrit-dependent recovery. To mitigate these challenges, we explored the utility of volumetric DBS (vDBS) cards, which are known to deposit a fixed volume of blood that gets analyzed.Materials and methods: Samples (quality control, proficiency testing, lead spiked, and patient samples that were positive for lead) were pipetted onto the backs of vDBS cards. Extracts were analyzed using Inductively Coupled Plasma-Tandem Mass Spectrometry in collision/reaction cell mode with oxygen gas. Deming regression analyses evaluated whole blood and vDBS analyzed with aqueous calibrators; vDBS analyzed with aqueous and DBS calibrators. Samples with varying hematocrit were assessed for impact on recovery.Results: A comparison of vDBS cards (n = 119) prepared from previously tested and lead spiked samples, analyzed against aqueous calibrators and vDBS calibrators, showed linear results: slope 1.024 (95% CI: 0.998 to 1.051) and y-intercept -0.0204 (95% CI: -0.4287 to 0.3879). Bias noted between whole blood lead and vDBS lead samples with varying hematocrit levels was not statistically significant.Conclusion: vDBS can be analyzed without matrix-matched calibrators to simplify routine assessment.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1075-1081"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148917973","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 review of microsampling techniques for the analysis of chemical threat agents in biological matrices. 生物基质中化学威胁因子分析的微采样技术综述。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-10-02 DOI: 10.1080/17576180.2026.2739184

Trinity K Rudd, Robert C diTargiani

{"title":"A review of microsampling techniques for the analysis of chemical threat agents in biological matrices.","authors":"Trinity K Rudd, Robert C diTargiani","doi":"10.1080/17576180.2026.2739184","DOIUrl":"10.1080/17576180.2026.2739184","url":null,"abstract":"Microsampling techniques have revolutionized the collection and analysis of biological samples, offering significant advantages for the detection of chemical threat agents in remote or resource-limited environments. This review explores advancements in microsampling technologies, highlighting the application of established formats including dried blood spots (DBS) and volumetric absorptive microsampling (VAMS) devices for detecting key chemical warfare agent (CWA) biomarkers, such as alkyl methylphosphonic acid (AMPA) metabolites from nerve agents and protein adducts from sulfur mustard. Applications for toxins and potent synthetic opioids like fentanyl are also detailed. The review examines the analytical methods, primarily based on mass spectrometry and chromatography, used for verifying exposure from these low-volume samples. Additionally, it discusses the logistical benefits of microsampling, such as reduced storage requirements and simplified transportation. While established methods provide robust retrospective verification, emerging technologies, such as continuous monitoring biosensors and microneedle arrays, hold the potential to offer promising solutions for real-time detection and diagnosis. Future advancements in microsampling devices and analytical methods will likely expand their applications, enhancing preparedness and response capabilities in chemical threat scenarios.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"18 12-13","pages":"1159-1182"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103419","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

From ADA positivity to clinical decision: a context-of-use framework for reflex testing, sampling frequency and stopping rules in immunogenicity assessment. 从ADA阳性到临床决策：免疫原性评估中反射检测、采样频率和停止规则的使用背景框架

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-09-12 DOI: 10.1080/17576180.2026.2732419

Ahmad Z Al Meslamani, Anan S Jarab, Husam El Sharu, Khadeijah Ahmed Al Marshoodi, Abdullah Elrefae, Mohammad Esmaeel Kataf

{"title":"From ADA positivity to clinical decision: a context-of-use framework for reflex testing, sampling frequency and stopping rules in immunogenicity assessment.","authors":"Ahmad Z Al Meslamani, Anan S Jarab, Husam El Sharu, Khadeijah Ahmed Al Marshoodi, Abdullah Elrefae, Mohammad Esmaeel Kataf","doi":"10.1080/17576180.2026.2732419","DOIUrl":"10.1080/17576180.2026.2732419","url":null,"abstract":"The clinical meaning of anti-drug antibody (ADA) positivity in biologic development, depends on context rather than incidence alone. This narrative review synthesizes regulatory guidance, consensus recommendations, bioanalytical literature, and selected clinical evidence published from January 2015 to mid-May 2026. It proposes a context-of-use framework for immunogenicity assessment. ADA testing should be designed around decisions it is expected to support, including pharmacokinetics/, pharmacodynamics (PK/PD) interpretation, efficacy, safety, labeling, dose selection, treatment interruption, and development progression. Product, patient, trial, and assay inform high-, moderate-, and low-consequence settings. Baseline, on-treatment, post-treatment, and event-based sampling times tailored to the compound's half-life, the drug's assay tolerance, exposure-response time windows, and safety risk. Confirmed ADA should reflex to titer, neutralizing antibody, domain-specific, cross-reactivity, or isotype tests. If there are archived samples, supervision, and established criteria for restarting testing, stopping or de-escalating testing may be considered after adequate exposure, suitable assays, and no apparent signal associated with ADA.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1117-1129"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148954767","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

Glycosylation-based distinction of endogenous and recombinant complement factor H enables selective quantification in human plasma. 基于糖基化的内源性和重组补体因子H的区分能够在人血浆中选择性定量。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-10-01 DOI: 10.1080/17576180.2026.2740919

Alexander Schäfer, Paulina Dabrowska-Schlepp, Andreas Busch, Jian-You Chen, Michael Wiesener, Christoph Siethoff

{"title":"Glycosylation-based distinction of endogenous and recombinant complement factor H enables selective quantification in human plasma.","authors":"Alexander Schäfer, Paulina Dabrowska-Schlepp, Andreas Busch, Jian-You Chen, Michael Wiesener, Christoph Siethoff","doi":"10.1080/17576180.2026.2740919","DOIUrl":"10.1080/17576180.2026.2740919","url":null,"abstract":"Background: Therapeutic proteins constitute an important class of biologics, including recombinant coagulation factors, enzyme-replacement therapies and hormones. Generally, a high degree of structural similarity between endogenous and therapeutic proteins is essential. From a pharmacokinetic perspective, however, it is advantageous to selectively quantify the exogenous protein.Research design: This study presents a strategy for the specific quantification of CPV 104, a recombinant form of complement factor H (FH), in human plasma. Because CPV 104 is identical in amino acid sequence to endogenous FH, differential HPLC-MS/MS analysis was used to identify structural features that discriminate both forms.Results: Differential analysis revealed unique glycosylation patterns on CPV 104, enabling development of a targeted HPLC-MS/MS assay for CPV 104-specific glycopeptides. Assay robustness was further enhanced by incorporating CPV 104 with stable isotope labeled glycan residues as an internal standard. High-throughput analysis was achieved through integration with an affinity enrichment step using a custom FH specific resin, supporting 96 well processing. The method was fully validated and demonstrated excellent specificity, precision, and accuracy. The validated assay was applied to a first in human pharmacokinetics study while simultaneously monitoring endogenous FH.Conclusions: This work outlines a generalizable approach for identifying molecular differences between endogenous and recombinant proteins and leveraging these features to develop high-quality bioanalytical assays.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"18 12-13","pages":"1095-1106"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644591/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103493","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

STAT3 phosphorylation as an endpoint in a functional cell-based neutralizing antibody assay with potential for broad application. STAT3磷酸化作为功能性细胞中和抗体测定的终点，具有广泛应用的潜力。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-08-01 Epub Date: 2026-09-01 DOI: 10.1080/17576180.2026.2725401

Michael Luong, Vitaly Ablamunits, Brianna McPhee, Ying Wang

{"title":"STAT3 phosphorylation as an endpoint in a functional cell-based neutralizing antibody assay with potential for broad application.","authors":"Michael Luong, Vitaly Ablamunits, Brianna McPhee, Ying Wang","doi":"10.1080/17576180.2026.2725401","DOIUrl":"10.1080/17576180.2026.2725401","url":null,"abstract":"Background: PF-07314470 is an antibody that was tested in a first-in-human study to evaluate its safety, pharmacokinetics, and pharmacodynamics. Because PF-07314470 is an interleukin-27 receptor (IL-27 R) agonist, the feasibility of a cell-based neutralizing antibody (NAb) assay was assessed as a tool to characterize anti-drug antibodies (ADA). Identifying a suitable assay endpoint is critical to NAb assay development. Phosphorylation of signal transducer and activator of transcription 3 (STAT3) was chosen, because it reflected activation of IL-27 R and could be measured by different means.Methods: PF-07314470 was used to activate IL-27 R on engineered Chinese Hamster ovary (CHO) cells, and resultant phospho-STAT3 (pSTAT3) levels were measured using a Meso Scale Discovery (MSD) assay. Experiments were conducted to confirm specificity of the pSTAT3 response and its inhibition by a NAb positive control. Biotin-Drug Extraction and Acid Dissociation (BEAD) was used to enhance drug tolerance.Results: PF-07314470 induced pSTAT3 that was reliably measured by MSD. The pSTAT3 response was specific to PF-07314470 and could only be inhibited by a positive control against PF-07314470. Assay sensitivity and drug tolerance were achieved through implementation of BEAD.Conclusions: Experiments demonstrated the feasibility of a cell-based NAb assay for PF-07314470. The assay system could be used for other biotherapeutics that modulate pSTAT3.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1055-1063"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148863374","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