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Development of LC-MS/MS method for cyanoenone triterpenoid determination to support CNS tissue distribution study. 开发测定氰烯酮三萜类化合物的 LC-MS/MS 方法，以支持中枢神经系统组织分布研究。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-04-01 Epub Date: 2024-02-21 DOI: 10.4155/bio-2023-0246
Lynn Tian, William Lafon, Qingguo Tian, Edward Tamer
{"title":"Development of LC-MS/MS method for cyanoenone triterpenoid determination to support CNS tissue distribution study.","authors":"Lynn Tian, William Lafon, Qingguo Tian, Edward Tamer","doi":"10.4155/bio-2023-0246","DOIUrl":"10.4155/bio-2023-0246","url":null,"abstract":"<p><p><b>Aims:</b> Cyanoenone triterpenoids penetrate the CNS, exhibiting biological activity via the nuclear factor E2-related factor (Nrf2) pathway. This is the first report on methods for the quantification of cyanonenone triterpenoids' distribution in various CNS tissues by LC-MS/MS. <b>Materials & methods:</b> The analyte was extracted from brain tissue homogenate using protein precipitation and supported liquid extraction. <b>Results & conclusion:</b> The assay validated a quantification range of 3.00-3000 ng/g in brain tissue samples as low as 5 mg. All parameters, including interference (≤20% at LLOQ) and accuracy/precision (15%, with 20% at LLOQ), met acceptance criteria. This assay supported a CNS distribution study, analyzing more than 10 mouse brain regions successfully.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"127-134"},"PeriodicalIF":1.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911963","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
Eliminating drug target interference with specific antibody or its F(ab')2 fragment in the bridging immunogenicity assay. 消除桥接免疫原性试验中特异性抗体或其 F(ab')2 片段对药物靶点的干扰。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-04-01 Epub Date: 2024-02-22 DOI: 10.4155/bio-2023-0191
Xiaojie Deng, Yingying Hou, Wenyi Yuan, Hongzhou Yang, Ruowen Guo, Tingting Liu, Yongzhen Liu, Junjiu Xu, Heng Liu, Likun Gong, Qiuping Qin
{"title":"Eliminating drug target interference with specific antibody or its F(ab')<sub>2</sub> fragment in the bridging immunogenicity assay.","authors":"Xiaojie Deng, Yingying Hou, Wenyi Yuan, Hongzhou Yang, Ruowen Guo, Tingting Liu, Yongzhen Liu, Junjiu Xu, Heng Liu, Likun Gong, Qiuping Qin","doi":"10.4155/bio-2023-0191","DOIUrl":"10.4155/bio-2023-0191","url":null,"abstract":"<p><p><b>Background:</b> DB-1003 is a humanized anti-IgE monoclonal antibody with higher affinity than omalizumab. In the affinity capture elution (ACE)-based bridging electrochemiluminescent immunoassay (ECLIA) for antibodies to DB-1003, monkey serum IgE caused false-positive results. <b>Materials & methods:</b> The target-specific antibody or its F(ab')<sub>2</sub> fragment was used to mitigate drug target interference in an ACE-based bridging ECLIA for the detection of anti-DB-1003 antibodies. <b>Results:</b> The sensitivity of the developed assay was at least 100 ng/ml. When the anti-drug antibody concentration was 250 ng/ml, the assay tolerated at least 20.0 μg/ml of the monkey IgE. <b>Conclusion:</b> Incorporating the target-specific antibody or its F(ab')<sub>2</sub> fragment can overcome the interference from monkey serum IgE in ACE-based bridging ECLIA for anti-DB-1003 antibody detection.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"135-148"},"PeriodicalIF":1.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929857","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
Inception and development of a LC-MS/MS assay for the multiplexed quantitation of nine human drug transporter biomarkers. 开始并开发一种 LC-MS/MS 分析方法，用于对九种人类药物转运生物标志物进行多重定量。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-20 DOI: 10.4155/bio-2023-0197
Eugene P Kadar, Christopher L Holliman, Manoli Vourvahis, A David Rodrigues
{"title":"Inception and development of a LC-MS/MS assay for the multiplexed quantitation of nine human drug transporter biomarkers.","authors":"Eugene P Kadar, Christopher L Holliman, Manoli Vourvahis, A David Rodrigues","doi":"10.4155/bio-2023-0197","DOIUrl":"10.4155/bio-2023-0197","url":null,"abstract":"<p><p><b>Background:</b> It has become common practice to assess solute carrier transporter (SLC)-mediated drug-drug interactions (DDIs) by quantitating various individual endogenous compounds as biomarkers in human plasma and urine. The goal of this work was to develop biomarker multiplex assays that could be utilized during first in human studies to support the simultaneous assessment of clinical DDI risk across various SLCs. <b>Methodology:</b> Hydrophilic interaction chromatography-MS/MS methods were developed, and validations were performed. <b>Results:</b> The multiplex assays were applied to a first in human study. Placebo/reference subject biomarker data were consistent with single assay in-house and published data. <b>Conclusion:</b> This work demonstrates the utility of these multiplex methods to support the concurrent evaluation of clinical DDI risk across various SLCs.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"347-362"},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139904939","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
Molecularly imprinted electrochemical biosensor for thrombin detection by comparing different monomers. 通过比较不同单体的分子印迹电化学生物传感器检测凝血酶。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 DOI: 10.4155/bio-2023-0203
Fatih Turk, Nimet Yildirim-Tirgil
{"title":"Molecularly imprinted electrochemical biosensor for thrombin detection by comparing different monomers.","authors":"Fatih Turk, Nimet Yildirim-Tirgil","doi":"10.4155/bio-2023-0203","DOIUrl":"10.4155/bio-2023-0203","url":null,"abstract":"<p><p><b>Aim:</b> Investigating molecularly imprinted polymers (MIPs) in electrochemical biosensors for thrombin detection, an essential protein biomarker. Comparing different monomers to showcase distinct sensitivity, specificity and stability advantages. <b>Materials & methods:</b> Dopamine, thionine and ethanolamine serve as monomers for MIP synthesis. Electrochemical methods and atomic force microscopy characterize sensor surfaces. Performance is evaluated, emphasizing monomer-specific electrochemical responses. <b>Results:</b> Monomer-specific electrochemical responses highlight dopamine's superior signal change and stability over 30 days. Notably, a low 5 pg/ml limit of detection, a broad linear range (5-200 pg/ml) and enhanced selectivity against interferents are observed. <b>Conclusion:</b> Dopamine-based MIPs show promise for high-performance electrochemical thrombin biosensors, suggesting significant applications in clinical diagnostics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"331-345"},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139995455","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
Utilizing droplet digital polymerase chain reaction for siRNA quantitation in rodent plasma and tissue via stem-loop reverse transcription. 利用液滴数字聚合酶链式反应，通过干环逆转录对啮齿动物血浆和组织中的 siRNA 进行定量。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-21 DOI: 10.4155/bio-2023-0228
Megan K Turski, Matthew E Albertolle
{"title":"Utilizing droplet digital polymerase chain reaction for siRNA quantitation in rodent plasma and tissue via stem-loop reverse transcription.","authors":"Megan K Turski, Matthew E Albertolle","doi":"10.4155/bio-2023-0228","DOIUrl":"10.4155/bio-2023-0228","url":null,"abstract":"<p><p><b>Background:</b> siRNA is a promising therapeutic modality highlighted by several US FDA approvals since 2018, with many more oligonucleotide assets in clinical development. To support siRNA discovery and development, robust and sensitive quantitative platforms for bioanalysis must be established to assess pharmacokinetic/pharmacodynamic relationships and toxicology. Droplet digital PCR offers improved sensitivity and throughput, as well as reduced susceptibility to matrix effects, compared with other analytical platforms. <b>Methodology:</b> The authors developed a stem-loop reverse transcription droplet digital PCR method to measure siRNA in mouse plasma and liver extract using bioanalytical method qualification guidelines. <b>Conclusion:</b> This newly developed assay has been demonstrated to be a superior alternative to other platforms, with the added benefit of greater sensitivity, with dynamic range from 390 to 400,000 copies/reaction and readiness for FDA investigational new drug-enabling applications.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"375-388"},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911966","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
Simultaneous determination of tramadol in earwax and urine samples: effects of age, duration time and sex. 同时测定耳屎和尿液样本中的曲马多：年龄、持续时间和性别的影响。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-21 DOI: 10.4155/bio-2023-0217
Adnan M Massadeh, Nuseer H Al-Rawi, May T Fayyad, Ali M Shotar, Mudhaffar I Al-Farras, Saif Addeen A Massadeh
{"title":"Simultaneous determination of tramadol in earwax and urine samples: effects of age, duration time and sex.","authors":"Adnan M Massadeh, Nuseer H Al-Rawi, May T Fayyad, Ali M Shotar, Mudhaffar I Al-Farras, Saif Addeen A Massadeh","doi":"10.4155/bio-2023-0217","DOIUrl":"10.4155/bio-2023-0217","url":null,"abstract":"<p><p><b>Background:</b> This study aims to determine the concentrations of tramadol in earwax (μg/g) and urine (μg/ml) samples taken from postoperative patients, to evaluate the sensitivity of earwax (cerumen) as an alternative analyte and compare it with the findings in urine samples. <b>Results:</b> The results indicated that tramadol concentrations in earwax samples were averaged 45.08 μg/g (range: 13.5-107.7 μg/g), whereas tramadol concentrations in urine samples were averaged 4.97 μg/ml (range: 1.57-10.11 μg/ml). There were significant differences when comparing age groups, duration and sex between earwax and urine samples (p < 0.05). <b>Conclusion:</b> Despite the significant differences between earwax and urine samples, earwax can be used as a bioindicator of tramadol detection.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"363-374"},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911964","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
Development, validation and application of an ion-pair reversed-phase liquid chromatography-tandem mass spectrometry method for the quantification of nusinersen. 开发、验证和应用离子对反相液相色谱-串联质谱法定量检测纽西奈森。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0218
Xiao Zhang, Chunjie Sha, Wei Zhang, Fengjuan Zhao, Mingli Zhu, Guangyi Leng, Wanhui Liu
{"title":"Development, validation and application of an ion-pair reversed-phase liquid chromatography-tandem mass spectrometry method for the quantification of nusinersen.","authors":"Xiao Zhang, Chunjie Sha, Wei Zhang, Fengjuan Zhao, Mingli Zhu, Guangyi Leng, Wanhui Liu","doi":"10.4155/bio-2023-0218","DOIUrl":"10.4155/bio-2023-0218","url":null,"abstract":"<p><p><b>Background:</b> The fully phosphorothioate-modified oligonucleotide (OGN) nusinersen has low ionization efficiency in the negative ion mode, resulting in a low mass spectrometry response. There have been no relevant reports on developing a LC-MS method for the determination of nusinersen by optimizing mobile phase composition. <b>Materials & methods:</b> Mobile phase additives comprised of 15 mM triethylamine/25 mM 1,1,1,3,3,3-hexafluoro-2-propanol with a pH of 9.6. Nusinersen was extracted from plasma using Oasis<sup>®</sup> HLB solid-phase extraction (Waters, MA, USA). <b>Results & conclusion:</b> By adjusting the pH of the mobile phase to 9.6 by optimizing the type and concentration of ion-pair reagents, a high mass spectrometry response was obtained. The developed method was applied to nusinersen and met the requirements for the pharmacokinetic study of nusinersen in rabbits.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"305-317"},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705979","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
A high-speed microscopy system based on deep learning to detect yeast-like fungi cells in blood. 基于深度学习的高速显微镜系统，用于检测血液中的酵母样真菌细胞。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0193
Ruiqi Liu, Xiaojie Li, Yingyi Liu, Lijun Du, Yingzhu Zhu, Lichuan Wu, Bo Hu
{"title":"A high-speed microscopy system based on deep learning to detect yeast-like fungi cells in blood.","authors":"Ruiqi Liu, Xiaojie Li, Yingyi Liu, Lijun Du, Yingzhu Zhu, Lichuan Wu, Bo Hu","doi":"10.4155/bio-2023-0193","DOIUrl":"10.4155/bio-2023-0193","url":null,"abstract":"<p><p><b>Background:</b> Blood-invasive fungal infections can cause the death of patients, while diagnosis of fungal infections is challenging. <b>Methods:</b> A high-speed microscopy detection system was constructed that included a microfluidic system, a microscope connected to a high-speed camera and a deep learning analysis section. <b>Results:</b> For training data, the sensitivity and specificity of the convolutional neural network model were 93.5% (92.7-94.2%) and 99.5% (99.1-99.5%), respectively. For validating data, the sensitivity and specificity were 81.3% (80.0-82.5%) and 99.4% (99.2-99.6%), respectively. Cryptococcal cells were found in 22.07% of blood samples. <b>Conclusion:</b> This high-speed microscopy system can analyze fungal pathogens in blood samples rapidly with high sensitivity and specificity and can help dramatically accelerate the diagnosis of fungal infectious diseases.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"289-303"},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705978","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
Risk-based approach of bioanalytical methods for clinical immunogenicity assessment of multidomain biotherapeutics. 基于风险的多域生物治疗临床免疫原性评估生物分析方法。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0250
Yan Mao, Kelly Coble
{"title":"Risk-based approach of bioanalytical methods for clinical immunogenicity assessment of multidomain biotherapeutics.","authors":"Yan Mao, Kelly Coble","doi":"10.4155/bio-2023-0250","DOIUrl":"10.4155/bio-2023-0250","url":null,"abstract":"<p><p>Tweetable abstract Risk-based bioanalytical method development for clinical antidrug antibody detection and characterization of multidomain biotherapeutics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"271-275"},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705981","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
Strategy and validation of a nonclinical generic plug-and-play antidrug antibody method for human monoclonal antibody biotherapeutics. 用于人类单克隆抗体生物治疗的非临床通用即插即用抗药抗体方法的战略和验证。
IF 1.8 4区 医学
Bioanalysis Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI: 10.4155/bio-2023-0184
Rodd Polsky, George Gunn, Kimberly J Reese, Charles Scott Hottenstein, Andrew Gehman, Ann Schwartz, Devin Root, Amy Concannon
{"title":"Strategy and validation of a nonclinical generic plug-and-play antidrug antibody method for human monoclonal antibody biotherapeutics.","authors":"Rodd Polsky, George Gunn, Kimberly J Reese, Charles Scott Hottenstein, Andrew Gehman, Ann Schwartz, Devin Root, Amy Concannon","doi":"10.4155/bio-2023-0184","DOIUrl":"10.4155/bio-2023-0184","url":null,"abstract":"<p><p>The measurement of antidrug antibodies (ADA) in nonclinical studies provides limited value because the formation and incidence of nonclinical ADA does not translate to clinical experience. The formation and presence of ADA in nonclinical species can, however, correlate to reduced drug exposure and safety observations including vasculitis and immune complex disease. Generic ADA methods for humanized monoclonal antibody biotherapeutics mitigate the need to develop bespoke ADA methods during nonclinical drug development. A drug-tolerant, sensitive, generic ADA immunoassay has been developed and validated for measuring ADA in cynomolgus monkey serum samples, allowing for immediate qualification of future monoclonal antibody biotherapeutics. This approach allows us to differentiate complexed and free ADA in a rapidly deployable manner when needed.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"277-287"},"PeriodicalIF":1.8,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139705982","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
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