Bioanalysis最新文献_第3页

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

Pharmacokinetic study of isavuconazonium in human plasma measured by HPLC-MS/MS and its use in healthy Chinese subjects. HPLC-MS/MS法测定异唑康唑在人血浆中的药动学研究及其在中国健康人群中的应用。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-19 DOI: 10.1080/17576180.2025.2548195

Linlin Qiu, Jie Lin, Yuchen Su, Yifu Kong, Yanli Zhou, Yifang Chen, Yonghua Yu

{"title":"Pharmacokinetic study of isavuconazonium in human plasma measured by HPLC-MS/MS and its use in healthy Chinese subjects.","authors":"Linlin Qiu, Jie Lin, Yuchen Su, Yifu Kong, Yanli Zhou, Yifang Chen, Yonghua Yu","doi":"10.1080/17576180.2025.2548195","DOIUrl":"10.1080/17576180.2025.2548195","url":null,"abstract":"Aims: To establish a rapid, sensitive HPLC-MS/MS method for quantifying isavuconazonium in human plasma and characterize its pharmacokinetics in healthy Chinese subjects under fasting and postprandial conditions.Materials & methods: Plasma samples were processed via acetonitrile protein precipitation. Separation was performed on an LC-20ADXR Plus C18 column with gradient elution (0.01% formic acid/acetonitrile). Detection used a Triple Quad 4500 mass spectrometer with MRM; isavuconazole-d4 was the internal standard. The method was validated, then applied to a crossover study in 32 healthy subjects (fasting vs. postprandial).Results: The method showed good linearity (4-4000 ng/mL, R2 ≥0.9801) with LLOQ 4 ng/mL. Stability was confirmed under various conditions (e.g. 53 days at -20°C, 66 days at -80°C). Pharmacokinetic results revealed food delayed Tmax (2.5 vs. 5.0 h) and reduced Cmax (1929.68 vs. 1300.17 ng/mL) but did not affect AUC0-t.Conclusions: The validated HPLC-MS/MS method is rapid and reliable for therapeutic drug monitoring. Food affects absorption but not total exposure, guiding clinical dosing in Chinese populations.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1031-1039"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12416188/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871205","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

Overcoming target interference in bridging anti-drug antibody (ADA) assay by optimizing sample treatment. 通过优化样品处理克服桥接抗药物抗体（ADA）检测中的靶标干扰。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-09-02 DOI: 10.1080/17576180.2025.2546709

Sally Ye, Janice Gambardella, Lioudmila Zaslavskaia, Daniel Kim, Andrey Konovalov, Stephanie Kostuk, Hamid Samareh Afsari, Corina Place, Kelly Coble, Alison J Johnson

{"title":"Overcoming target interference in bridging anti-drug antibody (ADA) assay by optimizing sample treatment.","authors":"Sally Ye, Janice Gambardella, Lioudmila Zaslavskaia, Daniel Kim, Andrey Konovalov, Stephanie Kostuk, Hamid Samareh Afsari, Corina Place, Kelly Coble, Alison J Johnson","doi":"10.1080/17576180.2025.2546709","DOIUrl":"10.1080/17576180.2025.2546709","url":null,"abstract":"Background: Drug bridging immunoassays are widely employed as the standard approach for detecting anti-drug antibodies (ADAs) in the development of new biological entities. A major challenge in these assays is mitigating target interference, particularly when the soluble target exists in dimeric forms, which can result in false positive signals and compromise assay specificity.Research design and methods: We developed sensitive and robust ADA assays capable of overcoming target interference to detect antibodies against BI X in both cynomolgus monkey (cyno) plasma and human serum matrices. This was achieved through the implementation of simple sample treatment techniques, specifically, acidification using a panel of different acids, to disrupt dimeric target interactions and minimize the interference.Results: Optimization of the acid dissociation and subsequent neutralization steps significantly reduced target interference in both cyno and human matrices. These improvements were achieved without the need for additional assay development or complex depletion strategies.Conclusions: Compared to previously reported methods for mitigating target interference, the acid panel treatment approach is simpler, more time-efficient, and cost-effective. This user-friendly strategy can be readily applied to eliminate soluble dimeric targets during ADA method development, particularly in cases where alternative methodologies are not feasible or applicable.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"17 15","pages":"941-950"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12413034/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144940760","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 method for co-estimation of doxorubicin and piperine: formulation development and pharmacokinetic studies. LC-MS/MS联合估计阿霉素和胡椒碱的方法：处方开发和药代动力学研究。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-25 DOI: 10.1080/17576180.2025.2548198

Pooja Yadav, Divya Chauhan, Pavan Kumar Yadav, Amit Kashyap, Jiaur R Gayen, Manish K Chourasia

{"title":"LC-MS/MS method for co-estimation of doxorubicin and piperine: formulation development and pharmacokinetic studies.","authors":"Pooja Yadav, Divya Chauhan, Pavan Kumar Yadav, Amit Kashyap, Jiaur R Gayen, Manish K Chourasia","doi":"10.1080/17576180.2025.2548198","DOIUrl":"10.1080/17576180.2025.2548198","url":null,"abstract":"Introduction: Oral metronomic chemotherapy employs a low-dose combination of chemotherapeutics administered regularly to minimize toxicity while enhancing anticancer efficacy. The clinical utility of Doxorubicin (DOX) is limited due to severe cardiotoxicity. Interestingly, Piperine (PIP) has been explored to mitigate DOX-induced toxicity while enhancing its therapeutic efficacy. Solid lipid nanoparticles (SLNs) offer an efficient drug delivery approach to improve oral bioavailability and controlled release of DOX and PIP.Areas covered: LC-MS/MS method was developed and validated per US-FDA bioanalytical guidelines to quantify DOX and PIP in plasma simultaneously. SLNs were developed and optimized using design expert software and exhibited particle size of 151.56 ± 0.32 nm, polydispersity index (PDI) of 0.172 ± 0.02, and surface charge of -22.83 ± 0.66 mV. Pharmacokinetic evaluation in female Sprague-Dawley rats showed enhanced AUC₀-∞ for DOX (31911.78 ± 226.92 ng/mL) and PIP (7377.66 ± 655.78 ng/mL), indicating improved systemic exposure.Expert opinion: The findings highlight the potential of SLN-based co-delivery of DOX and PIP for oral metronomic chemotherapy. The validated LC-MS/MS method ensures precise pharmacokinetic assessment, which is crucial for future clinical translation. This study provides a promising strategy for enhancing oral chemotherapy efficacy.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1017-1029"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12416174/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144940404","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

Selective IgM digestion improves anti-AAV IgG detection in the immune complex assay format. 选择性IgM消化提高了免疫复合物检测格式中抗aav IgG的检测。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-09-03 DOI: 10.1080/17576180.2025.2548191

Uwe Wessels, Alexander Pöhler, Francesca Ros, Kay-Gunnar Stubenrauch

引用次数: 0

Simultaneous quantitation of tigecycline, meropenem, polymyxin B in plasma, and protein-binding analysis in HSCT patients. 造血干细胞移植患者血浆中替加环素、美罗培南、多粘菌素B的同时定量和蛋白结合分析。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-08-01 Epub Date: 2025-08-25 DOI: 10.1080/17576180.2025.2546778

Yan Gong, Weijing Gong, Junmiao Chen, Zhuo Man, Wei Li, Wei Shi

引用次数: 0

Special consideration: commentary on the 2025 FDA Bioanalytical Method Validation for Biomarkers. 特别考虑：对2025年FDA生物标志物生物分析方法验证的评论。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-08-12 DOI: 10.1080/17576180.2025.2546280

Karen J Quadrini, Jiri Aubrecht, Nicholas M P King, Carmen Fernandez-Metzler, Yan G Ni, John-Michael Sauer, Lauren Stevenson, Steven P Piccoli

引用次数: 0

LC-MS/MS quantification of nusinersen in rat cerebrospinal fluid and preclinical pharmacokinetics study application. 大鼠脑脊液中nusinersen的LC-MS/MS定量及临床前药代动力学研究应用。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-07-21 DOI: 10.1080/17576180.2025.2535949

Yujie Li, Shu Zhang, Xiayi Wang, Xiaochuan Li, Lizhong Guo

{"title":"LC-MS/MS quantification of nusinersen in rat cerebrospinal fluid and preclinical pharmacokinetics study application.","authors":"Yujie Li, Shu Zhang, Xiayi Wang, Xiaochuan Li, Lizhong Guo","doi":"10.1080/17576180.2025.2535949","DOIUrl":"10.1080/17576180.2025.2535949","url":null,"abstract":"Background: Background: An oligonucleotide drug named nusinersen sodium is used to treat Spinal Muscular Atrophy (SMA), requires accurate detection for therapeutic research. There are no published reports on liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods for detecting nusinersen in rat cerebrospinal fluid (CSF).Methods: An LC-MS/MS method has been created and verified to detect nusinersen in Sprague-Dawley (SD) rat CSF. The method employed solid-phase extraction for post-extraction analysis and used dT20 as an internal standard. Negative ion multiple reaction monitoring (MRM) mode scanning and the electrospray ionization (ESI) source were used. The method was validated over a concentration range of 5-2000 ng/mL with a Lower Limit of Quantification (LLOQ) of for nusinersen at 5 ng/mL.Results and conclusions: The method achieves extremely high accuracy and precision, good linearity, high extraction recovery, and provides a useful approach for evaluating the pharmacokinetics of nusinersen in rats.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"839-846"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144673879","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

Effect of delayed blood centrifugation on cytokine quantitation in serum and plasma. 延迟血液离心对血清和血浆细胞因子定量的影响。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-08-12 DOI: 10.1080/17576180.2025.2544521

Xiaoyun Yang, Trinidad Arceo, Saloumeh K Fischer

{"title":"Effect of delayed blood centrifugation on cytokine quantitation in serum and plasma.","authors":"Xiaoyun Yang, Trinidad Arceo, Saloumeh K Fischer","doi":"10.1080/17576180.2025.2544521","DOIUrl":"10.1080/17576180.2025.2544521","url":null,"abstract":"Background: Cytokines are critical biomarkers, but their accurate measurement is susceptible to pre-analytical variables. This study investigated the effect of delayed blood processing on the quantitation of eight cytokines (CCL2, CXCL10, IFN-γ, IL-2Ra, IL-6, IL-7, IL-18, TNFα) in matched serum and plasma from healthy volunteers. Methods: Blood was processed immediately or after 3, 6, 24, and 48 hours, stored at room temperature or 4°C. Cytokines were quantified using a multiplexed Ella assay.Results: Our data showed only IL-2Ra remained stable across all conditions. The remaining cytokine concentrations were significantly impacted by processing delay and storage temperature, with changes evident as early as 3 hours and more pronounced at 24 and 48 hours (p < 0.05). Storing blood at 4°C generally mitigated changes compared to room temperature, but analyte-specific and matrix-dependent variations persisted.Conclusion: These findings emphasize delayed processing significantly alters cytokine levels, highlighting the importance of prompt, standardized processing and careful consideration of pre-analytical factors for reliable cytokine quantitation in clinical studies.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"913-921"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144820464","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

In-vitro metabolite identification for MEDI7219, an oral GLP-1 analog, using LC-MS/MS with CID and EAD approaches. 口服GLP-1类似物MEDI7219的体外代谢物鉴定，采用液相色谱-质谱联用CID和EAD方法。

IF 1.8 4区医学

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-08-19 DOI: 10.1080/17576180.2025.2535954

Kate Liu, Yue Huang, Taoqing Wang, Ruipeng Mu, Anton I Rosenbaum

{"title":"In-vitro metabolite identification for MEDI7219, an oral GLP-1 analog, using LC-MS/MS with CID and EAD approaches.","authors":"Kate Liu, Yue Huang, Taoqing Wang, Ruipeng Mu, Anton I Rosenbaum","doi":"10.1080/17576180.2025.2535954","DOIUrl":"10.1080/17576180.2025.2535954","url":null,"abstract":"Aim: Oral peptide therapeutics typically have short half-lives due to rapid degradation by digestive enzymes. Systematic peptide engineering and formulation optimization led to the development of a clinical candidate MEDI7219, an orally bioavailable glucagon-like peptide 1 (GLP-1) peptide, with greater stability than wild-type GLP-1 or semaglutide:~60% of MEDI7219 remained intact after 2 h in vitro incubation with simulated intestinal fluid. This study further investigates proteolytic stability by elucidating biotransformation products of MEDI7219 using liquid chromatography-mass spectrometry (LC-MS) methods.Method: Peptide metabolism was assessed using in vitro pancreatin assay followed by analysis utilizing liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) using collision-induced dissociation (CID) and electron-activated dissociation (EAD) approaches.Results: We have confidently identified 13 metabolites. Time course profiles of parent and metabolite peaks are consistent with sequential enzymatic cleavage pattern. The 13 metabolites mapped to 8 cleavage sites. Most of these cleavage sites can be explained by the specificity of digestive enzymes, e.g. trypsin, pepsin, and elastase. However, α-methyl-L-phenylalanine appeared to be well protected from chymotrypsin and pepsin digestion since no cleavage peptides ending with α-methyl-L-phenylalanine were observed.Conclusion: These study results provide further structural details explaining previously published stability data and provide new insights into potential GLP1 proteolytic liabilities for future engineering.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"881-888"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369624/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871204","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