Bioanalysis最新文献_第8页

Bioanalytical challenges and solutions for immunogenicity evaluation of bispecific antibody therapeutics. 双特异性抗体治疗免疫原性评价的生物分析挑战和解决方案。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-22 DOI: 10.1080/17576180.2026.2672456

Zhaojun Yin, Kun Peng

{"title":"Bioanalytical challenges and solutions for immunogenicity evaluation of bispecific antibody therapeutics.","authors":"Zhaojun Yin, Kun Peng","doi":"10.1080/17576180.2026.2672456","DOIUrl":"10.1080/17576180.2026.2672456","url":null,"abstract":"Bispecific antibodies (bsAbs) represent a rapidly expanding class of biotherapeutics that enable novel mechanisms of action beyond the conventional monoclonal antibodies (mAbs). While their clinical success continues to grow, the increased structural complexity, non-native architecture, and dual-targeting mechanisms introduce unique immunogenicity risks and sophisticated bioanalytical challenges. In this review, we examine the clinical immunogenicity profiles of approved and selected investigational bsAbs, highlighting key determinants that drive immunogenicity risk. We also discuss critical hurdles, considerations and emerging solutions in immunogenicity evaluation for bsAbs, including limitations of widely used anti-drug antibody (ADA) assay format, matrix interference, domain-specific characterization, and functional neutralization assessment. Finally, we propose an integrated immunogenicity assessment framework that combines predictive tools, clinical bioanalytical data, and reverse-translational investigations to refine therapeutic platforms and reduce immunogenicity risk in next-generation bsAb development. To support this evolution, we advocate enhanced industry transparency and the publication of immunogenicity results in detail, especially for programs terminated due to high immunogenicity. Together, these approaches aim to support more informed decision-making and enable the safe and effective advancement of complex bispecific antibody therapeutics.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"517-528"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321882/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147986326","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

Quantification of oxaliplatin and lansoprazole in tumor tissue homogenates by LC-MS/MS: a fit-for-purpose bioanalytical approach. LC-MS/MS定量分析肿瘤组织匀浆中的奥沙利铂和兰索拉唑：一种适合目的的生物分析方法。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-29 DOI: 10.1080/17576180.2026.2677734

Erica Alves, Gurupadayya Bannimath, Prabitha Prabhakaran

{"title":"Quantification of oxaliplatin and lansoprazole in tumor tissue homogenates by LC-MS/MS: a fit-for-purpose bioanalytical approach.","authors":"Erica Alves, Gurupadayya Bannimath, Prabitha Prabhakaran","doi":"10.1080/17576180.2026.2677734","DOIUrl":"10.1080/17576180.2026.2677734","url":null,"abstract":"Background: Quantification of drug concentrations within tumor tissue is essential for evaluating true intratumoral exposure, yet remains analytically challenging due to matrix complexity, protein binding, and drug instability. Existing LC-MS/MS methods for oxaliplatin and lansoprazole are primarily limited to plasma or pharmaceutical matrices.Methods: This study describes the development and fit-for-purpose evaluation, guided by ICH M10 principles, of LC-MS/MS methods for quantifying oxaliplatin and lansoprazole in murine tumor tissue homogenates. Isocratic separation on a C18 column with an ammonium acetate-acetonitrile mobile phase and compound-specific MRM detection enabled selective analysis.Results: The methods demonstrated acceptable linearity, agreement between nominal and back-calculated concentrations, controlled matrix effects, consistent extraction recovery, and satisfactory autosampler and freeze-thaw stability. The assays were successfully applied to determine intratumoral drug concentrations in control, monotherapy, and combination treatment groups.Conclusion: These matrix-matched LC-MS/MS methods provide a fit-for-purpose approach for exploratory intratumoral drug quantification and support more reliable assessment of pharmacologically relevant tumor exposure in preclinical studies.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"467-478"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321881/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148052242","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 humanoid robot for the bioanalytical laboratory? 生物分析实验室的人形机器人？

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-21 DOI: 10.1080/17576180.2026.2674994

Ming Li

引用次数: 0

A dual-stage stabilized LC-MS/MS method for the quantification of ibuprofenamine in human plasma. 双级稳定LC-MS/MS法定量人血浆中布洛芬胺。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-05-12 DOI: 10.1080/17576180.2026.2672460

Wenyuan Qi, Lei Yang, Panpan Xie, Aixin Shi, Wei Xue, Kexin Li

{"title":"A dual-stage stabilized LC-MS/MS method for the quantification of ibuprofenamine in human plasma.","authors":"Wenyuan Qi, Lei Yang, Panpan Xie, Aixin Shi, Wei Xue, Kexin Li","doi":"10.1080/17576180.2026.2672460","DOIUrl":"10.1080/17576180.2026.2672460","url":null,"abstract":"Background: Ibuprofenamine is a novel spray prodrug of ibuprofen designed to reduce gastrointestinal adverse effects through local administration. Its low systemic exposure and extreme susceptibility to rapid ex vivo enzymatic hydrolysis demand a highly sensitive and stabilized bioanalytical method.Research design and methods: We developed an LC-MS/MS assay using simple protein precipitation. A rigorous dual-stage stabilization strategy, which employed a high-capacity NaF/citric acid buffer during blood collection and an acidic vehicle prior to plasma extraction-was implemented to completely arrest prodrug degradation.Results: The method achieved a lower limit of quantification (LLOQ) of 40 pg/mL with a linear range of 40-2000 pg/mL. Intra- and inter-batch precision and accuracy were well within ±15%. The stabilization protocol extended sample stability to 120 days at -70°C, effectively eliminating ex vivo hydrolysis artifacts.Conclusions: This robust, dual-stage stabilized LC-MS/MS method effectively overcomes the bioanalytical challenges of labile ester prodrugs. It was successfully applied to support a clinical pharmacokinetic study of ibuprofenamine spray.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"447-455"},"PeriodicalIF":2.1,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147925956","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

Correction. 修正。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-04-01 Epub Date: 2026-01-19 DOI: 10.1080/17576180.2026.2619351

引用次数: 0

Optimizing acid type and pH for dissociation of biotin-labeled drug from streptavidin-coated bead in BEAD ADA assays. 优化酸类型和pH解离生物素标记的药物从链霉亲和素包被珠在bead ADA测定。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-03-01 Epub Date: 2026-05-19 DOI: 10.1080/17576180.2026.2672458

Lili Guo, Yong Jiang, Christopher Ehlinger

{"title":"Optimizing acid type and pH for dissociation of biotin-labeled drug from streptavidin-coated bead in BEAD ADA assays.","authors":"Lili Guo, Yong Jiang, Christopher Ehlinger","doi":"10.1080/17576180.2026.2672458","DOIUrl":"10.1080/17576180.2026.2672458","url":null,"abstract":"Background/aim: The biotin-drug extraction with acid dissociation (BEAD) assay is used to enhance drug tolerance when detecting anti-drug antibodies (ADAs) during biotherapeutic development. A critical step of it is the acid-induced elution of ADA from the biotin-labeled drug immobilized on streptavidin-coated-beads (SA-beads). Although biotin binds streptavidin extremely tight, the dissociation dynamics between the biotin-labeled drug or the entire ADA-biotin-drug complex and SA-beads remain uncharacterized under acidic conditions. This study characterizes biotin-labeled drug dissociation and develops a systematic approach to optimize BEAD.Method/result: Acid-induced dissociation was observed in a modified ADA bridging assay and the Biolayer Interferometry (BLI) analysis. Dissociation magnitude depended on the acid type and pH, with reduced sensitivity to acid concentration and exposure time. Acetic acid at pH 2.65, lactic acid at pH 2.23, and glycine at pH 3.00 produced the greatest dissociation, whereas acids at pH 4 produced the slowest rate. From these findings, we developed an optimization workflow focusing on concentrations of biotin- and ruthenium-labeled drugs in Master-Mix, SA-bead amount, and initial biotin-labeled drug.Conclusion: The manuscript proposes a fit-for-purpose optimization framework and provides guidance in acid selection and reagent tuning to improve drug tolerance and assay efficiency across ADA workflows.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"345-354"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13215316/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147970068","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

Sensitive amplified luminescent proximity homogeneous assay for the quantitative detection of growth differentiation factor 15 and its application in cardiovascular disease. 灵敏放大发光接近均质法定量检测生长分化因子15及其在心血管疾病中的应用

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-03-01 Epub Date: 2026-05-21 DOI: 10.1080/17576180.2026.2668680

Nannan Tian, Meichun Chen, Songzhao Zhang, Junhong Wang, Biao Huang, Shangbin Kao, Tianyu Zheng, Yuan Qin, Xueqin Zhao, Zhirong Zhang, Xiumei Zhou

{"title":"Sensitive amplified luminescent proximity homogeneous assay for the quantitative detection of growth differentiation factor 15 and its application in cardiovascular disease.","authors":"Nannan Tian, Meichun Chen, Songzhao Zhang, Junhong Wang, Biao Huang, Shangbin Kao, Tianyu Zheng, Yuan Qin, Xueqin Zhao, Zhirong Zhang, Xiumei Zhou","doi":"10.1080/17576180.2026.2668680","DOIUrl":"10.1080/17576180.2026.2668680","url":null,"abstract":"Objective: This study aimed to develop a rapid, high-sensitive, and accurate amplified luminescent proximity homogeneous assay (AlphaLISA) for measuring plasma concentrations of growth differentiation factor 15 (GDF15) and assessing its application value in the diagnosis of cardiovascular disease (CVD).Methods: Based on the AlphaLISA method, plasma GDF15 levels were quantified in healthy controls (HCs), heart failure (HF), and myocardial infarction (MI) patients using a double-antibody sandwich format. The diagnostic efficiency of GDF15 for HF and MI was assessed by ROC curve analysis.Results: The established GDF15-AlphaLISA took only 15 minutes with good linearity (R2 >0.99) and wide detection range (0.072 ~ 200 ng/mL). The intra- and inter-analytical precision were within 10%, and the recovery rate was 96.06% ~109.41%. There was no significant cross-reactivity with CVD biomarkers (Galectin-3, ST2, cTnI) or with other TGF-β superfamily members (TGF-β1, GDF8, BMP2, BMP6). Results showed that GDF15 could significantly distinguish HCs and patients (p < 0.0001), and ROC curve showed that GDF15 had a high diagnostic efficiency for HF and MI (AUC >0.95).Conclusion: We have successfully established a sensitive and rapid GDF15-AlphaLISA method, which can promote the timely diagnosis of HF and MI, and it is a good auxiliary means for the initial diagnosis of HF and MI.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"383-394"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13215295/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147980347","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 inconsistent DNA extraction recovery across tissue types in qPCR assays supporting biodistribution studies. 克服不一致的DNA提取恢复跨组织类型的qPCR分析支持生物分布研究。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-03-01 Epub Date: 2026-04-27 DOI: 10.1080/17576180.2026.2664205

Ting Jiang, Zhaomeng Feng, Long Yuan

{"title":"Overcoming inconsistent DNA extraction recovery across tissue types in qPCR assays supporting biodistribution studies.","authors":"Ting Jiang, Zhaomeng Feng, Long Yuan","doi":"10.1080/17576180.2026.2664205","DOIUrl":"10.1080/17576180.2026.2664205","url":null,"abstract":"Aims: DNA biodistribution studies are essential in the development of cell and gene therapies. A key step of these studies is the extraction of vector DNA (vDNA) and genomic DNA (gDNA) from complex biological samples. In this work, key DNA extraction parameters were evaluated and optimized to ensure consistent and efficient DNA recovery.Methods: Recovery was evaluated in multiple tissue types by spiking known amounts of vDNA and/or mouse gDNA into surrogate rabbit matrices, performing extraction using a DNA extraction kit under various conditions, and then quantifying the recovered DNA by qPCR and comparing with those spiked post extraction.Results: Parameters including proteinase K incubation, RNase amount, DNA binding beads amount, and tissue input were systematically evaluated and found to play a significant role in recovery. By optimizing these parameters, consistently high recovery was achieved across various tissue types including brain, liver, and spinal cord from mouse, rabbit, and non-human primates.Conclusion: Proteinase K incubation, RNase amount, tissue input, and DNA binding beads volume were identified as key parameters influencing DNA recovery from tissue samples. The findings provide valuable insights for researchers to evaluate and optimize their own extraction protocols, ultimately enhancing the reliability and accuracy in supporting biodistribution studies.","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"355-366"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13215310/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147760856","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

Comparison of 2D-LC and LC-MS/MS self- calibration internal standard method for the determination of quetiapine in serum. 2D-LC与LC-MS/MS自校准内标法测定血清中喹硫平的比较。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-03-01 Epub Date: 2026-05-14 DOI: 10.1080/17576180.2026.2668682

Mengli Ding, Xiaodan Li, Bi Zhang, Xuefang Yan

{"title":"Comparison of 2D-LC and LC-MS/MS self- calibration internal standard method for the determination of quetiapine in serum.","authors":"Mengli Ding, Xiaodan Li, Bi Zhang, Xuefang Yan","doi":"10.1080/17576180.2026.2668682","DOIUrl":"10.1080/17576180.2026.2668682","url":null,"abstract":"Objective: 2D-LC method and LC-MS/MS self-calibrated internal standard method were used to compared the consistency and correlation of quetiapineserum concentration.Methods: Quality control samples at low, medium, and high concentrations of quetiapine, as well as serum samples from 138 psychiatric patients taking quetiapine, were analyzed using 2D-LC and LC-MS/MS self-calibrated internal standard method, respectively. Performed a complete validation of both methods. The Bland-Altman plot was used to assess the consistency of the results, while Pearson correlation analysis and Passing-Bablok regression were used to analyze the correlation among the results.Outcomes: The linear range for 2D-LC was 60.74-1518.48 ng/ml, and the linear range for LC-MS/MS self-calibrated internal standard method was 60.88-1522.02 ng/ml. For both methods, the relative standard deviation of intraday and daily precision was less than 15%. Calculated using the Bland-Altman plot, the 95.65% LoA was (-11.85, 30.82). The Passing-Bablok regression equation was OLZLC-MS/MS = 2.44 + 1.06 × OLZ2D-LC, and the Pearson correlation coefficient was 0.994 (p < 0.001).Conclusion: The 2D-LC and LC-MS/MS self-calibrated internal standard method, exhibit exceptional agreement and correlation in the quantification of quetiapine concentrations in serum. which can be used for conventional therapeutic drug monitoring (TDM).","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"333-343"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13215313/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147926001","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

Cut point validation vs. real-world performance: the ultra-low cut point dilemma. 切点验证vs.实际性能：超低切点困境。

IF 2.1 4区医学

Bioanalysis Pub Date : 2026-03-01 Epub Date: 2026-05-16 DOI: 10.1080/17576180.2026.2672454

Lindsay Denhoff, Cansu Dernek, Liam Heins, Chong Gu, Allie Renfro, Stephanie Pasas-Farmer, Robert Kernstock

引用次数: 0