Bioanalysis生物分析
Bioanalysis(英文缩写 BIOANALYSIS),ISSN 1757-6180,eISSN 1757-6199,中文译名:生物分析 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-10-01 至 2026-09-30，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2021 | 2.695 | Q3 |
| 2022 | 1.800 | Q3 |
| 2023 | 1.900 | Q3 |
| 2024 | 1.800 | Q3 |
| 2025 | 2.100 | Q3 |
Bioanalysis 最新收录文献
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1. Recent developments in microsampling for oligonucleotides and biologics bioanalysis.
PMID:日期:2026-10-04The expanding landscape of therapeutic modalities, including monoclonal antibodies and oligonucleotide-based drugs, has created a need for sensitive and efficient bioanalytical strategies. Traditional blood sampling approaches pose significant limitations, including volume constraints, patient burden, and increased study complexity. Microsampling provides a transformative alternative, enabling low-volume (<100 µL), minimally invasive sample collection while supporting serial sampling and improved translational study design. This review highlights recent advances in microsampling techniques, including dried blood spots (DBS), volumetric absorptive microsampling (VAMS), and capillary microsampling (CMS), with focus on applications to protein therapeutics and oligonucleotides. Selected biomarker and protein/proteomics applications are also discussed where they provide practical insight into microsampling implementation for larger modalities. Key challenges, including hematocrit effects, recovery, matrix-dependent bias, stability, collection-site effects, and sensitivity limitations, are discussed alongside innovations in hybridization-based extraction, ligand-binding assays, and LC-MS workflows that enable reliable quantitation in microliter-scale samples. Despite these advances, broader implementation in regulated settings remains limited by regulatory considerations and the need to demonstrate concordance with conventional sampling. Ongoing efforts to harmonize best practices and improve analytical robustness are expected to accelerate adoption. Overall, microsampling offers opportunities to reduce burden, enhance efficiency, and expand access to high-quality PK data across emerging therapeutic modalities.
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2. A review of microsampling techniques for the analysis of chemical threat agents in biological matrices.
PMID:日期:2026-10-02Microsampling 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.
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3. Glycosylation-based distinction of endogenous and recombinant complement factor H enables selective quantification in human plasma.
PMID:日期:2026-10-01Therapeutic 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. 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. 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. 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.
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4. Understanding Alzheimer's disease through biomarkers: pathology, progression, and clinical application.
PMID:日期:2026-09-30Alzheimer'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].
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5. LC-triple quadrupole-MS based quantitative analysis of tafenoquine in rat plasma and red blood cells: method development and validation.
PMID:日期:2026-09-24For 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. 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. 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. 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.
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6. Two-dimensional transition metal dichalcogenides for biosensing: synthesis strategies, material properties, and biomarker detection applications.
PMID:日期:2026-09-22Two-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.
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7. From urine to serum: blood-based matrices reshape the future of anti-doping testing.
PMID:日期:2026-09-21For more than five decades, urine has been the cornerstone biological matrix for anti-doping testing because of its noninvasive collection, broad analytical applicability, and favorable detection windows. However, evolving doping practices, including microdosing, increased use of biological medicines, and substances with limited urinary excretion, have exposed limitations of a urine-centered approach. At the same time, advances in liquid chromatography-tandem mass spectrometry (LC-MS/MS), high-resolution mass spectrometry (HRMS), and microsampling technologies have strengthened the potential of blood-based testing. Serum and dried blood spots (DBS) provide direct access to circulating analytes and physiological responses, offering complementary information to urine. These matrices have demonstrated particular value for detecting erythropoiesis-stimulating agents (ESAs), steroid esters, peptide hormones, and biomarkers incorporated into the Athlete Biological Passport (ABP). Emerging capillary blood collection devices further simplify sample collection and may facilitate wider implementation of blood-based anti-doping strategies. This review discusses the expanding role of serum, DBS, and capillary blood collection technologies in anti-doping analysis. Using ESA detection as an illustrative example, we examine how matrix selection affects detection capability and analytical performance. We also highlight applications in steroid monitoring, biological profiling, and future omics-based approaches, supporting the integration of blood-derived matrices into complementary multi-matrix anti-doping testing strategies.
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8. From ADA positivity to clinical decision: a context-of-use framework for reflex testing, sampling frequency and stopping rules in immunogenicity assessment.
PMID:日期:2026-09-12The 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.
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9. Evaluation of volumetric DBS for lead analysis using ICP-MS/MS: addressing matrix effects and hematocrit variability.
PMID:日期:2026-09-10Lead 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. 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. A comparison of vDBS cards ( = 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. vDBS can be analyzed without matrix-matched calibrators to simplify routine assessment.
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10. 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.
PMID:日期:2026-09-06MK-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. 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. 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. 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.