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Bioanalysis Rising Star Award 2026: interviews with the finalists. 2026年生物分析新星奖:入围者访谈。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-20 DOI: 10.1080/17576180.2026.2701582
Dakshat Trivedi, Ethan Sanford, Giorgi Kobidze, Richa Pandey, Emma Hall
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引用次数: 0
Label-free SERS for the detection of renal failure biomarkers in blood serum using gold nanoparticles as a substrate. 无标记SERS检测肾功能衰竭生物标志物在血清中使用金纳米颗粒作为底物。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-07-22 DOI: 10.1080/17576180.2026.2705705
Fozia Sarfraz, Misbah Naeem, Muhammad Irfan Majeed, Haq Nawaz, Nosheen Rashid, Muhammad Zeeshan Majeed, Hafiza Elbadie Ahmed, Allah Ditta, Benish Saif, Zainab Iftikhar, Kashif Ali, Sundas Irshad, Fareeha Ghulam Qadir, Usman Munawar, Muhammad Imran
{"title":"Label-free SERS for the detection of renal failure biomarkers in blood serum using gold nanoparticles as a substrate.","authors":"Fozia Sarfraz, Misbah Naeem, Muhammad Irfan Majeed, Haq Nawaz, Nosheen Rashid, Muhammad Zeeshan Majeed, Hafiza Elbadie Ahmed, Allah Ditta, Benish Saif, Zainab Iftikhar, Kashif Ali, Sundas Irshad, Fareeha Ghulam Qadir, Usman Munawar, Muhammad Imran","doi":"10.1080/17576180.2026.2705705","DOIUrl":"10.1080/17576180.2026.2705705","url":null,"abstract":"<p><strong>Background: </strong>Renal failure (RF) requires rapid and accurate diagnosis to improve patient outcomes and quality of life. Conventional diagnostic methods are often invasive and time-consuming, highlighting the need for sensitive analytical approaches.</p><p><strong>Research design and methods: </strong>Gold nanoparticles (AuNPs) were used as surface-enhanced Raman spectroscopy (SERS) substrates to identify biomarkers in serum samples from healthy individuals and RF patients with varying creatinine levels. Raman spectral fingerprints of proteins, lipids, carbohydrates, nucleic acids, creatinine, urea, and uric acid were analyzed. Principal component analysis (PCA) was used for data reduction, partial least squares regression (PLSR) for creatinine prediction, and support vector machine (SVM) and partial least squares discriminant analysis (PLS-DA) for sample classification. No treatment regimen or adverse-event assessment was involved.</p><p><strong>Results: </strong>AuNP-assisted SERS enhanced Raman signals and enabled discrimination between healthy and RF serum samples. PLSR supported quantitative prediction of creatinine concentration, while SVM and PLS-DA classified healthy and diseased samples with high accuracy.</p><p><strong>Conclusions: </strong>SERS combined with AuNPs and multivariate analysis provides a sensitive platform for RF biomarker detection in blood serum. However, spectral variability, reproducible AuNPs substrate preparation, and validation using larger clinical datasets remain important challenges.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"899-910"},"PeriodicalIF":2.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540243/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148560661","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
Advanced assay design for characterizing anti-drug antibody responses in clinical serum samples. 先进的分析设计表征抗药物抗体反应在临床血清样本。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-08-07 DOI: 10.1080/17576180.2026.2712128
Gregor P Lotz, Denise Sickert, Roland F Staack, Gregor Jordan
{"title":"Advanced assay design for characterizing anti-drug antibody responses in clinical serum samples.","authors":"Gregor P Lotz, Denise Sickert, Roland F Staack, Gregor Jordan","doi":"10.1080/17576180.2026.2712128","DOIUrl":"10.1080/17576180.2026.2712128","url":null,"abstract":"<p><p>Monitoring anti-drug antibody (ADA) responses is critical for evaluating the safety and efficacy of protein therapeutics. While traditional three-tiered testing (screening, confirmation, titration) reliably identifies ADA incidence, onset and magnitude, modern, complex biologics necessitate adapting our assessment strategies. Consequently, advanced assay designs are required to capture the full biological and clinical impact of these immune responses. Structured to guide bioanalytical scientists through this paradigm shift, this review first explores the transition toward integrated functional assessments, detailing how \"active\" pharmacokinetic (PK) and pharmacodynamic (PD) assays, neutralizing antibody (nAb) testing, and domain-specific assays help align immunogenicity characterization with a drug's mechanism of action (MoA). Next, we highlight Model-Informed Assay Development (MIAD) as a transformative tool for optimizing drug tolerance and estimating ADA-Reagent-Drug complex (ARC) formation. We then outline a risk-based, fit-for-purpose (FFP) framework for developing these advanced assays. Furthermore, we provide practical considerations for reporting advanced characterization data in regulatory filings. Finally, we conclude by differentiating benign ADA release from active inflammatory responses driven by the interaction of complex biologics with antigen-presenting cells, and explore future perspectives, specifically how Systems Immunogenicity and Artificial Intelligence (AI) will transition the field from retrospective monitoring to predictive immunogenicity profiling.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"933-945"},"PeriodicalIF":2.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540198/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148688383","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
Investigating the relationship between relative accuracy and linearity acceptance criteria in bioassay validation for clinical studies. 研究临床研究中生物测定验证的相对准确度和线性度可接受标准之间的关系。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-08-10 DOI: 10.1080/17576180.2026.2715915
Pietro Piu, Stefano Auddino, Gioele Bernardoni, Emanuele Montomoli, Alessandro Manenti
{"title":"Investigating the relationship between relative accuracy and linearity acceptance criteria in bioassay validation for clinical studies.","authors":"Pietro Piu, Stefano Auddino, Gioele Bernardoni, Emanuele Montomoli, Alessandro Manenti","doi":"10.1080/17576180.2026.2715915","DOIUrl":"10.1080/17576180.2026.2715915","url":null,"abstract":"<p><strong>Background: </strong>Relative accuracy (RA) and linearity are distinct validation characteristics in bioassay validation, yet quantitative relationships between their acceptance criteria are rarely defined. This study investigated how predefined RA tolerances determine admissible linearity acceptance ranges.</p><p><strong>Research design and methods: </strong>A theoretical framework for assessing dilutional linearity was established using a b-fold serial dilution design. Relative accuracy was defined as the ratio of observed to expected geometric means, evaluated against a tolerance threshold (θ). Linearity was determined through linear regression of logb(GMobserved) against logb(Dilution). Analytical expressions were derived for acceptable slope intervals based on θ and the number of valid dilution levels. A simulated bioassay dataset illustrated its application.</p><p><strong>Results: </strong>Analytical derivations showed that admissible slope intervals depend exclusively on θ and the number of valid dilution levels. The resulting limits were invariant with respect to both the initial geometric mean and the dilution fold factor. In the illustrative example, the proposed framework supported acceptance of linearity while retaining all valid dilution levels.</p><p><strong>Conclusions: </strong>This study provides a mathematically consistent method for deriving linearity acceptance criteria directly from predefined RA requirements. Although illustrated using simulated data, it offers a tool for dilution-based bioassay validation and may support more coherent validation decisions.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"991-1000"},"PeriodicalIF":2.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148700618","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
Bioanalysis Rising Star Award 2026: interviews with the finalists. 2026年生物分析新星奖:入围者访谈。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-07-20 DOI: 10.1080/17576180.2026.2701582
Dakshat Trivedi, Ethan Sanford, Giorgi Kobidze, Richa Pandey, Emma Hall
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引用次数: 0
A UHPLC-MS/MS method for the simultaneous quantification of BTK inhibitors and their active metabolite in human plasma and cerebrospinal fluid. UHPLC-MS/MS同时定量人血浆和脑脊液中BTK抑制剂及其活性代谢物的方法
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-07-15 DOI: 10.1080/17576180.2026.2700356
Sijia Li, Jiameng Xie, Fan Xia, Tingting Yang, Fangyue Zheng, Liyan Miao, Chenrong Huang
{"title":"A UHPLC-MS/MS method for the simultaneous quantification of BTK inhibitors and their active metabolite in human plasma and cerebrospinal fluid.","authors":"Sijia Li, Jiameng Xie, Fan Xia, Tingting Yang, Fangyue Zheng, Liyan Miao, Chenrong Huang","doi":"10.1080/17576180.2026.2700356","DOIUrl":"10.1080/17576180.2026.2700356","url":null,"abstract":"<p><strong>Background: </strong>Bruton's tyrosine kinase inhibitors (BTKis, ibrutinib, zanubrutinib, orelabrutinib) are key targeted therapies for B-cell lymphomas, but interindividual variability and adverse reactions limit their use. Metabolized by CYP3A, co-medications or hepatic dysfunction cause plasma fluctuations, necessitating therapeutic drug monitoring (TDM). Cerebrospinal fluid (CSF) distribution is also critical for CNS lymphoma treatment.</p><p><strong>Objective: </strong>To develop and validate a UHPLC-MS/MS method for simultaneous quantification of three BTKis and one metabolite in human plasma and CSF to support TDM.</p><p><strong>Methods: </strong>After protein precipitation with methanol, samples were analyzed on an ACQUITY HSS T3 column with a 3-min gradient at 0.3 mL/min and ESI (+) MRM. Mobile phase: water-acetonitrile-formic acid-ammonium acetate (1 M) (950:50:1:1, A) and (50:950:1:1, B).</p><p><strong>Results: </strong>The method showed excellent selectivity and linearity (<i>r</i> > 0.997) over 1-200 ng/mL (ibrutinib, zanubrutinib, ibrutinib metabolite) and 5-1000 ng/mL (orelabrutinib) in both matrices. Recoveries were 89.4-103.8%, matrix factors 0.93-1.06, and precision CV ≤8.5%. Stability was confirmed. The method was applied to 34 clinical samples (25 plasma, 9 CSF) from 20 patients.</p><p><strong>Conclusion: </strong>This method detects four BTK-related analytes in plasma/CSF with a 3-min run time, evaluation of hemolytic/lipemic matrices, and clinical validation, increasing throughput, reducing costs, and broadening applicability, providing preliminary feasibility data for clinical TDM.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"873-883"},"PeriodicalIF":2.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148444253","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 HSK21542 in rat plasma and tissues by LC-MS/MS: an application to pharmacokinetics and tissue distribution study. LC-MS/MS定量大鼠血浆和组织中HSK21542的药代动力学和组织分布研究
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-07-11 DOI: 10.1080/17576180.2026.2701923
Jie Fang, Zeyu Wang, Kaijuan Cao, Kan Zhong, Hongjiao Dong, Ju Wang, Xiaoli Gou, Chen Zhang, Pingming Tang, Xiaoyan Chen
{"title":"Quantification of HSK21542 in rat plasma and tissues by LC-MS/MS: an application to pharmacokinetics and tissue distribution study.","authors":"Jie Fang, Zeyu Wang, Kaijuan Cao, Kan Zhong, Hongjiao Dong, Ju Wang, Xiaoli Gou, Chen Zhang, Pingming Tang, Xiaoyan Chen","doi":"10.1080/17576180.2026.2701923","DOIUrl":"10.1080/17576180.2026.2701923","url":null,"abstract":"<p><strong>Background: </strong>HSK21542 is a novel, peripherally selective kappa opioid receptor (KOR) agonist under development for the treatment of pain and pruritus. This study aimed to develop a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantifying HSK21542 in rat plasma and tissue homogenate.</p><p><strong>Research design and methods: </strong>A sensitive LC-MS/MS method using d<sub>4</sub>-HSK21542 as the internal standard was developed and validated in rat plasma and tissue homogenates. Sprague Dawley (SD) rats received single intravenous doses of HSK21542 at 0.1, 0.3, or 1.0 mg/kg, or repeated intravenous doses of 0.3 mg/kg twice daily for 7 days. Tissue distribution was evaluated after a single intravenous dose of 0.3 mg/kg.</p><p><strong>Results: </strong>The method was fully validated and demonstrated good linearity for rat plasma (0.500 - 500 ng/mL) and rat liver homogenate (2.50 - 2500 ng/g). HSK21542 exhibited high clearance (mean CL 36.0 - 44.7 mL/min/kg), a short terminal half-life (2-3 h), multi-exponential pharmacokinetic characteristics, and dose-proportional exposure, with no pharmacologically significant accumulation after multiple doses. Tissue distribution studies indicated rapid and wide distribution, with the highest concentrations found in the kidney, bladder, and liver.</p><p><strong>Conclusion: </strong>The validated LC-MS/MS method was suitable for preclinical HSK21542 analysis. These pharmacokinetic and tissue distribution profiles provided essential data supporting its further clinical development.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"885-897"},"PeriodicalIF":2.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148418210","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 and validation of a sensitive HPLC-MS/MS method for the analysis of semaglutide in human plasma. 高效液相色谱-质谱联用/质谱联用方法分析人血浆中西马鲁肽的建立与验证。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-08-03 DOI: 10.1080/17576180.2026.2712160
Christopher Tudan, Joel Stickling, Emily Northwick Darden, Lauren Devine, Shane Needham
{"title":"Development and validation of a sensitive HPLC-MS/MS method for the analysis of semaglutide in human plasma.","authors":"Christopher Tudan, Joel Stickling, Emily Northwick Darden, Lauren Devine, Shane Needham","doi":"10.1080/17576180.2026.2712160","DOIUrl":"10.1080/17576180.2026.2712160","url":null,"abstract":"<p><strong>Background: </strong>Semaglutide is a human glucagon-like peptide-1 (GLP-1) peptide analog. To date, the literature does not report a validated HPLC-MS/MS assay using a triple-quadrupole mass spectrometer for the quantitation of semaglutide in human plasma in support of pharmacokinetics. A robust, sensitive HPLC--MS/MS assay supporting this class of compounds, is provided and full validation demonstrated.</p><p><strong>Methods and results: </strong>A triple-quadrupole HPLC-MS/MS method has been developed and fully validated for the quantitation of semaglutide in human plasma, using a stable isotope labeled internal standard and an effective, efficient protein precipitation sample extraction. The method has a sensitive analytical range of 5 ng/mL to 200 ng/mL (and to 1000 ng/mL with a dilution QC) and exhibits excellent accuracy (92.7% to 109.4%) and precision of <10.6%. This highly selective method provided high recovery of the analyte, with minimal matrix effects.</p><p><strong>Conclusion: </strong>A robust and simple HPLC-MS/MS method to quantify semaglutide in human plasma has been fully validated in accordance with the 2022 FDA M10 guidance. This method is suitable for implementation in clinical studies within the validated analytical range and stability conditions and can be extended to the bioanalysis of other GLP-1 peptide-based therapeutics with similar structural and physiochemical properties.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"971-980"},"PeriodicalIF":2.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148663442","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 and validation of a LC-MS/MS method for the quantification of the E-type prostanoid receptor 4 antagonist HTL0039732 in human plasma, for a Phase I/IIa clinical trial. 开发和验证LC-MS/MS方法定量人血浆中e型前列腺素受体4拮抗剂HTL0039732,用于I/IIa期临床试验。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-08-06 DOI: 10.1080/17576180.2026.2712785
Dan Astley, Svatopluk Svetlik, Shelby Barnett, Gareth J Veal
{"title":"Development and validation of a LC-MS/MS method for the quantification of the E-type prostanoid receptor 4 antagonist HTL0039732 in human plasma, for a Phase I/IIa clinical trial.","authors":"Dan Astley, Svatopluk Svetlik, Shelby Barnett, Gareth J Veal","doi":"10.1080/17576180.2026.2712785","DOIUrl":"10.1080/17576180.2026.2712785","url":null,"abstract":"<p><strong>Background: </strong>HTL0039732 (HTL) is a novel E-type prostanoid receptor 4 (EP4) antagonist for the treatment of advanced solid tumors. An analytical method was developed to facilitate the analysis of patient samples as part of an ongoing Phase I/IIa clinical trial.</p><p><strong>Methods and results: </strong>A LC-MS/MS method for quantifying HTL in human plasma was developed and validated per regulatory guidelines. The assay was selective, with a 2 ng/mL detection limit observed. It demonstrated good precision (CV ≤11.9%) and accuracy (86-101%), with linearity from 10 to 2000 ng/mL. Recovery was consistent, and no significant matrix, anticoagulant, or carryover effects were observed.</p><p><strong>Conclusions: </strong>A sensitive and selective method for measuring HTL in human plasma was successfully developed and applied to clinical samples, generating first‑in‑human pharmacokinetic data for HTL. The assay is now being utilized in an early‑phase clinical trial setting.</p><p><strong>Clinical trial registration: </strong>https://clinicaltrials.gov/study/NCT05944237.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"981-990"},"PeriodicalIF":2.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13463273/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148676520","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 analytical similarity to clinical confidence: how regulatory evolution ensures comparable immunogenicity in streamlined biosimilar development. 从分析相似性到临床信心:调节进化如何确保流线型生物仿制药开发的可比免疫原性。
IF 2.1 4区 医学
Bioanalysis Pub Date : 2026-07-01 Epub Date: 2026-08-18 DOI: 10.1080/17576180.2026.2715916
Sandra Ribes, Marc Rosenbaum, Laura Hartmann, Lisa Allmannsberger, Johann Poetzl
{"title":"From analytical similarity to clinical confidence: how regulatory evolution ensures comparable immunogenicity in streamlined biosimilar development.","authors":"Sandra Ribes, Marc Rosenbaum, Laura Hartmann, Lisa Allmannsberger, Johann Poetzl","doi":"10.1080/17576180.2026.2715916","DOIUrl":"10.1080/17576180.2026.2715916","url":null,"abstract":"<p><p>Biosimilars are biological medicines developed once exclusivity for the reference product has lapsed and are regulated through a stringent approval pathway, demonstrating the same efficacy, similar safety, and immunogenicity as their reference products. After two decades of clinical experience and scientific progress, regulatory agencies worldwide are transitioning toward a streamlined (also named tailored) biosimilar development that primarily relies on analytical and pharmacokinetic (PK) similarity, without routinely requiring comparative efficacy studies (CES). This narrative review discusses how comparable immunogenicity is demonstrated within streamlined development. Comparable analytical data provide the pivotal evidence for concluding comparable immunogenicity of a biosimilar candidate. Scientific evidence shows that PK similarity studies provide immunogenicity outcomes highly concordant with those observed in CES. Well-designed PK studies, particularly in healthy volunteers, provide sensitive and clinically informative immunogenicity assessments while minimizing confounding factors associated with disease and concomitant treatments. These studies can adequately characterize the onset, magnitude, and evolution of humoral immune responses without underestimating comparative immunogenicity. In the future, <i>in silico</i> and <i>in vitro</i> tools may enable additional risk-based assessment of immunogenicity differences between biosimilar and reference product. In conclusion, extensive scientific and regulatory evidence supports that streamlined biosimilar development provides a scientifically rigorous framework for demonstrating comparable immunogenicity.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1031-1039"},"PeriodicalIF":2.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540188/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787721","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
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