workflow

工作流
  • 文章类型: Journal Article
    背景:试管婴儿实验室中的双人检查不能完全避免混淆或胚胎移植错误,数据转录或输入是耗时且冗余的,往往导致延误完成医疗记录。
    方法:本研究引入了基于工作流的RFID标签见证和实时信息输入平台,以应对这些挑战。为了评估其减少混淆的潜力,我们进行了精液准备的模拟实验,以分析其纠错率。此外,我们评估了它对工作效率的影响,特别是在操作和数据输入方面。此外,我们比较了纸质标签和RFID标签之间的周期成本。最后,我们回顾性分析了20,424个卵母细胞回收周期和15,785个冷冻胚胎移植周期的临床结果,分为纸质标签和RFID标签组。
    结果:研究表明,与纸质标签相比,RFID标签见证纠正了100%的标签错误,不影响配子/胚胎手术,并显著缩短了输入数据的时间,但RFID标签的周期成本明显较高。然而,在受精方面没有观察到显著差异,胚胎质量,囊胚率,临床妊娠,两组之间的活产率。
    结论:RFID标签见证不会对配子/胚胎操作产生负面影响,胚胎质量和妊娠结局,但它可能会降低混淆或错误的风险。尽管成本大幅增加,将RFID标签见证与实时信息输入集成可以显着减少数据输入时间,大大提高了工作效率。这种基于工作流的管理平台还增强了操作安全性,确保医疗信息的完整性,增强了胚胎学家的信心。
    BACKGROUND: Dual-person inspection in IVF laboratories cannot fully avoid mix-ups or embryo transfer errors, and data transcription or entry is time-consuming and redundant, often leading to delays in completing medical records.
    METHODS: This study introduced a workflow-based RFID tag witnessing and real-time information entry platform for addressing these challenges. To assess its potential in reducing mix-ups, we conducted a simulation experiment in semen preparation to analyze its error correction rate. Additionally, we evaluated its impact on work efficiency, specifically in operation and data entry. Furthermore, we compared the cycle costs between paper labels and RFID tags. Finally, we retrospectively analyzed clinical outcomes of 20,424 oocyte retrieval cycles and 15,785 frozen embryo transfer cycles, which were divided into paper label and RFID tag groups.
    RESULTS: The study revealed that comparing to paper labels, RFID tag witnessing corrected 100% of tag errors, didn\'t affect gamete/embryo operations, and notably shorten the time of entering data, but the cycle cost of RFID tags was significantly higher. However, no significant differences were observed in fertilization, embryo quality, blastocyst rates, clinical pregnancy, and live birth rates between two groups.
    CONCLUSIONS: RFID tag witnessing doesn\'t negatively impact gamete/embryo operation, embryo quality and pregnancy outcomes, but it potentially reduces the risk of mix-ups or errors. Despite highly increased cost, integrating RFID tag witnessing with real-time information entry can remarkably decrease the data entry time, substantially improving the work efficiency. This workflow-based management platform also enhances operational safety, ensures medical informational integrity, and boosts embryologist\'s confidence.
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  • 文章类型: Journal Article
    小眼症转录因子(MiT)家族易位肾细胞癌(tRCC)是一种罕见的,侵略性,和肾癌的异质性亚型,这不是很好的特征。由于遗传改变总是与癌变有关,蛋白质是生物学特征的主要执行者,多组学研究可以全面揭示tRCC的系统生物学过程。这里,我们详细描述了表征tRCC的蛋白质基因组工作流程,为将来tRCC和其他恶性肿瘤的整合蛋白质基因组分析提供知识基础。
    Microphthalmia transcription factor (MiT) family translocation renal cell carcinoma (tRCC) is a rare, aggressive, and heterogeneous subtype of kidney cancer, which is not well characterized. Since genetic alterations are always associated with carcinogenesis, and proteins are the major executors of biological features, multi-omics studies can reveal the systematic tRCC biological process comprehensively. Here, we describe the proteogenomic workflow for characterization of tRCC in detail to provide the knowledge foundation for integrated proteogenomic analysis of tRCC and other malignant tumors in the future.
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  • 文章类型: Journal Article
    背景:本病例报告强调了标准化和全数字化序贯治疗在复杂咬合康复病例中的重要性。为了充分解决患者的牙科需求,这种情况通常需要多学科干预,包括牙周治疗,牙髓治疗,前美学,植入物修复,假肢康复。完全数字化的工作流程(包括面部扫描仪,口内扫描仪,下颌运动跟踪系统,虚拟咬合器,和计算机辅助设计软件)简化了复杂的处理,增强工作流程的简单性,效率,可见性,和精度。
    方法:患者表现为上下假体咀嚼效率下降,前牙的美学外观令人不满意。体格检查和放射学评估后,这个复杂的咬合康复案例需要牙周治疗,前美学增强,植入物修复,和固定假肢康复。因此,采用了完全数字化的工作流程。全冠假体放置在牙齿13、23和34上;固定桥包含位置32至42,单个植入物冠放置在牙齿35和36上。为牙齿12至22和44至46构造植入物支撑的固定桥,并通过植入物固定在牙齿12、22、44和46处。所有确定的假体都是由氧化锆陶瓷制成的,因其耐用性和美学特性而选择。最后,具有令人满意的美学和功能特征的修复体就座,保护牙齿及其支撑结构。在治疗和随访期间,T扫描咬合分析系统用于连续监测和指导患者牙弓咬合分布的调整。18个月后,患者仍然对最终的修复感到满意。
    结论:本报告旨在帮助牙医了解和实施复杂咬合康复病例管理过程中的标准化和完全数字化工作流程;它还可以促进美学和功能特征的和谐融合。
    BACKGROUND: This case report highlights the importance of standardized and fully digital sequential treatment in complex occlusal rehabilitation cases. To fully resolve the patient\'s dental needs, such cases often require multidisciplinary interventions including periodontal therapy, endodontic treatment, anterior esthetics, implant restoration, and prosthetic rehabilitation. A fully digital workflow (including facial scanners, intraoral scanners, jaw motion tracking systems, virtual articulators, and computer-aided design software) streamlined the complex treatment, enhancing workflow simplicity, efficiency, visibility, and precision.
    METHODS: The patient presented with decreased chewing efficiency of the upper and lower prostheses, along with unsatisfactory esthetic appearance of the anterior teeth. After physical examination and radiological assessment, this complex occlusal rehabilitation case required periodontal therapy, anterior esthetic enhancement, implant restoration, and fixed prosthetic rehabilitation. Therefore, a fully digital workflow was adopted. Full-crown prostheses were placed on teeth 13, 23, and 34; a fixed bridge encompassed positions 32 to 42, and single implant crowns were placed on teeth 35 and 36. Implant-supported fixed bridges were constructed for teeth 12 to 22 and 44 to 46, anchored by implants at teeth 12, 22, 44, and 46. All definitive prostheses were fabricated from zirconia ceramics, chosen for their durability and esthetic characteristics. Finally, restorations with satisfactory esthetic and functional characteristics were seated, preserving the tooth and its supporting structures. During treatment and follow-up, the T-scan occlusal analysis system was utilized to continuously monitor and guide the adjustment of occlusal distribution across the patient\'s dental arches. After 18 months, the patient remains satisfied with the definitive restorations.
    CONCLUSIONS: This report is intended to help dentists understand and implement standardized and fully digital workflows during the management of complex occlusal rehabilitation cases; it may also facilitate harmonious integration of esthetic and functional characteristics.
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  • 文章类型: Journal Article
    目的:回顾人工智能(AI)在增强神经影像学中MRI采集工作流程的效率和吞吐量方面的最新进展,包括规划,序列设计,和采集伪影的校正。
    方法:对最近基于AI的神经MRI采集方法进行了综合分析。研究重点是关键技术进步,它们对临床实践的影响,以及与这些方法相关的潜在风险。
    结果:研究结果表明,基于AI的算法对MRI采集过程具有实质性的积极影响,提高效率和吞吐量。特定的算法被认为在优化采集步骤方面特别有效,报告的工作流程效率有所改善。
    结论:这篇综述强调了AI在神经MRI采集中的转化潜力,强调技术进步和临床效益。然而,它还讨论了潜在的风险和挑战,建议未来的研究领域,以减轻这些担忧,并进一步加强MRI采集中的AI集成。
    OBJECTIVE: To review recent advances of artificial intelligence (AI) in enhancing the efficiency and throughput of the MRI acquisition workflow in neuroimaging, including planning, sequence design, and correction of acquisition artifacts.
    METHODS: A comprehensive analysis was conducted on recent AI-based methods in neuro MRI acquisition. The study focused on key technological advances, their impact on clinical practice, and potential risks associated with these methods.
    RESULTS: The findings indicate that AI-based algorithms have a substantial positive impact on the MRI acquisition process, improving both efficiency and throughput. Specific algorithms were identified as particularly effective in optimizing acquisition steps, with reported improvements in workflow efficiency.
    CONCLUSIONS: The review highlights the transformative potential of AI in neuro MRI acquisition, emphasizing the technological advances and clinical benefits. However, it also discusses potential risks and challenges, suggesting areas for future research to mitigate these concerns and further enhance AI integration in MRI acquisition.
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  • 文章类型: Journal Article
    背景:当前用于RNA-seq数据的RNA-seq分析软件倾向于在不同物种之间使用相似的参数,而不考虑物种特异性差异。然而,在分析来自不同物种的数据时,这些工具的适用性和准确性可能会有所不同,比如人类,动物,植物,真菌,和细菌。对于大多数缺乏信息科学背景的实验室研究人员来说,从可用的复杂分析工具中确定如何构建满足其特定需求的分析工作流程是一个重大挑战。
    结果:利用植物的RNA-seq数据,动物,和真菌,据观察,当应用于不同物种时,不同的分析工具表现出一些差异。进行了专门的植物病原真菌数据分析的综合实验,以差异基因分析为最终目标。在这项研究中,使用不同工具的288个管道被应用于分析五个真菌RNA-seq数据集,并根据仿真结果对其性能进行了评估。这导致建立了一个相对通用和优越的真菌RNA-seq分析管道,可以作为参考,并得出了一些选择分析工具的标准,以供参考。此外,我们比较了用于选择性剪接分析的各种工具。基于模拟数据的结果表明,rMATS仍然是最优选择,尽管可以考虑使用SpliceWiz等工具进行补充。
    结论:实验结果表明,与默认软件参数配置相比,调整后的分析组合结果可以提供更准确的生物学见解。有利于根据数据精心选择合适的分析软件,而不是不加区分地选择工具,以便更有效地获得高质量的分析结果。
    BACKGROUND: Current RNA-seq analysis software for RNA-seq data tends to use similar parameters across different species without considering species-specific differences. However, the suitability and accuracy of these tools may vary when analyzing data from different species, such as humans, animals, plants, fungi, and bacteria. For most laboratory researchers lacking a background in information science, determining how to construct an analysis workflow that meets their specific needs from the array of complex analytical tools available poses a significant challenge.
    RESULTS: By utilizing RNA-seq data from plants, animals, and fungi, it was observed that different analytical tools demonstrate some variations in performance when applied to different species. A comprehensive experiment was conducted specifically for analyzing plant pathogenic fungal data, focusing on differential gene analysis as the ultimate goal. In this study, 288 pipelines using different tools were applied to analyze five fungal RNA-seq datasets, and the performance of their results was evaluated based on simulation. This led to the establishment of a relatively universal and superior fungal RNA-seq analysis pipeline that can serve as a reference, and certain standards for selecting analysis tools were derived for reference. Additionally, we compared various tools for alternative splicing analysis. The results based on simulated data indicated that rMATS remained the optimal choice, although consideration could be given to supplementing with tools such as SpliceWiz.
    CONCLUSIONS: The experimental results demonstrate that, in comparison to the default software parameter configurations, the analysis combination results after tuning can provide more accurate biological insights. It is beneficial to carefully select suitable analysis software based on the data, rather than indiscriminately choosing tools, in order to achieve high-quality analysis results more efficiently.
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  • 文章类型: Journal Article
    Infectious diseases are a great threat to human health. Rapid and accurate detection of pathogens is important in the diagnosis and treatment of infectious diseases. Metagenomics next-generation sequencing (mNGS) is an unbiased and comprehensive approach for detecting all RNA and DNA in a sample. With the development of sequencing and bioinformatics technologies, mNGS is moving from research to clinical application, which opens a new avenue for pathogen detection. Numerous studies have revealed good potential for the clinical application of mNGS in infectious diseases, especially in difficult-to-detect, rare, and novel pathogens. However, there are several hurdles in the clinical application of mNGS, such as: (1) lack of universal workflow validation and quality assurance; (2) insensitivity to high-host background and low-biomass samples; and (3) lack of standardized instructions for mass data analysis and report interpretation. Therefore, a complete understanding of this new technology will help promote the clinical application of mNGS to infectious diseases. This review briefly introduces the history of next-generation sequencing, mainstream sequencing platforms, and mNGS workflow, and discusses the clinical applications of mNGS to infectious diseases and its advantages and disadvantages.
    传染病对人类健康产生巨大威胁。快速准确地检测出病原体对于传染病的诊断和治疗非常重要。宏基因组二代测序技术(mNGS)能无差别检测样本中所有的核酸(DNA和RNA)。随着测序和生物信息学技术的发展,mNGS正从实验室研究向临床应用迈进,为病原体检测开辟了新的途径。大量研究表明,mNGS在感染性疾病的临床应用中具有良好的潜力,尤其适用于难检测、罕见和新型病原。但是,mNGS在临床应用中仍存在一些问题:(1)缺乏通用的、可验证的工作流程和质量保证;(2)对高宿主背景和低生物量的样本不敏感;(3)缺乏对海量数据分析和报告解读的标准化指导。因此,全面了解这项新技术将有助于促进mNGS在感染性疾病中的临床应用。本文简要综述了二代测序技术的发展历史、主流测序平台和mNGS工作流程,并讨论了mNGS在感染性疾病中的临床应用及该技术的优缺点。.
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  • 文章类型: Journal Article
    低输入蛋白质组学,治疗数十到数百个哺乳动物细胞,是标准蛋白质组学和单细胞蛋白质组学之间的差距。低输入蛋白质组学应用广泛,需要特殊的样品制备方法来实现深度蛋白质组谱分析。本章介绍了用于处理低输入样品的易于使用和可扩展设备的制备和应用方案。蛋白质预浓缩,杂质去除,reduction,烷基化,消化,和脱盐完全整合到这个工作流程中,并且该装置可以直接连接到在线nanoLC-MS以避免样品转移。
    Low-input proteomics, which treats tens to hundreds of mammalian cells, is the gap between standard proteomics and single-cell proteomics. Low-input proteomics is widely applicable and needs special sample preparation methods to achieve deep proteome profiling. This chapter describes protocols for the preparation and application of an easy-to-use and scalable device for processing low-input samples. Protein preconcentration, impurity removal, reduction, alkylation, digestion, and desalting are fully integrated into this workflow, and the device can be directly connected to online nanoLC-MS to avoid sample transfer.
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  • 文章类型: Journal Article
    大量的微生物组测序数据已经产生,阐明了微生物与其环境表型(如宿主健康或生态系统状态)之间的关联。优秀的生物信息学工具是破译微生物组数据下隐藏的生物信息的基础。然而,大多数方法都给非专业用户的可访问性带来了困难。在另一边,在处理大规模数据集时,计算吞吐量已成为许多分析管道的重要瓶颈。在这项研究中,我们引入并行元套件(PMS),用于快速和全面的微生物组数据分析的交互式软件包,可视化,和解释。它涵盖了广泛的数据预处理功能,统计数据,在用户友好的图形界面中通过最先进的算法进行可视化,可供不同用户使用。为了满足快速增长的计算需求,PMS的整个过程已经通过并行计算方案进行了优化,能够快速处理成千上万的样品。PMS与多个平台兼容,和安装程序已集成全自动安装。
    Massive microbiome sequencing data has been generated, which elucidates associations between microbes and their environmental phenotypes such as host health or ecosystem status. Outstanding bioinformatic tools are the basis to decipher the biological information hidden under microbiome data. However, most approaches placed difficulties on the accessibility to nonprofessional users. On the other side, the computing throughput has become a significant bottleneck of many analytical pipelines in processing large-scale datasets. In this study, we introduce Parallel-Meta Suite (PMS), an interactive software package for fast and comprehensive microbiome data analysis, visualization, and interpretation. It covers a wide array of functions for data preprocessing, statistics, visualization by state-of-the-art algorithms in a user-friendly graphical interface, which is accessible to diverse users. To meet the rapidly increasing computational demands, the entire procedure of PMS has been optimized by a parallel computing scheme, enabling the rapid processing of thousands of samples. PMS is compatible with multiple platforms, and an installer has been integrated for full-automatic installation.
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  • 文章类型: Journal Article
    背景:在急诊科(ED)中,分诊护士每天承受着巨大的压力,需要迅速评估患者的敏锐度,并将收集到的信息记录到计算机中。有了自助服务技术,患者可以自己完成数据输入,让护士专注于高阶任务。信息亭是这种自助服务技术的一个流行的例子;然而,放置足够数量的笨重且固定的机器需要在问候区域中进行空间改变,并影响分诊流程。移动技术可以为这些问题提供解决方案。
    目的:本研究的目的是研究使用移动技术来改善ED中的预诊流程。
    方法:建议的移动技术堆栈包括患者携带的智能手机和QR技术。自注册应用程序的网址被编码为QR码,它直接张贴在步入式入口外面,让每一个流动的人都能看到。在患者或其代理人使用智能手机扫描代码后立即启动注册。患者可以在前往分诊区的任何地点完成数据输入。完成后,结果是本地保存在智能手机上。在分诊区,结果由便携式代码读取器自动解码,然后加载到分诊计算机中。该系统在上海三个繁忙的大都市ED中实施,中国。售货亭和智能手机都是随机评估的,同时用于指导患者的预诊流程。在每个中心的20天期间收集数据。使用事后情景问卷评估了模拟ED到达的医学生的及时性和可用性。可用性由分诊护士使用净启动子评分(NPS)进行评估。在系统实施过程中进行的观察需要进行定性主题分析。
    结果:总体而言,8575名患者中的5928名在信息亭进行了自我注册,8532名患者中的7330名在智能手机上登记。与信息亭相比,使用智能手机时,参考努力显着降低(43.7%vs8.8%;P<.001),平均预诊等待时间显着减少(4.4,SD1.7vs2.9,SD1.0分钟;P<.001)。“任务完成容易度”的平均可用性得分存在显着差异(4.4,SD1.5vs6.7,SD0.7;P<.001),“完成时间满意度”(4.5,SD1.4vs6.8,SD0.6;P<.001),和“支持满意度”(4.9,标准差1.9vs6.6,标准差1.2;P<.001)。与使用信息亭相比,分诊护士在实施移动自我注册后提供了更高的NPS(13.3%vs93.3%;P<.001)。确定了改进的排队模型,并按顺序步骤对定性发现进行了分组。
    结论:这项研究表明,患者携带的智能手机是ED自我注册的有用工具。随着可用性的提高和量身定制的排队模型,建议的系统有望最大程度地减少ED中患者的分诊等待。
    BACKGROUND: In emergency departments (EDs), triage nurses are under tremendous daily pressure to rapidly assess the acuity level of patients and log the collected information into computers. With self-service technologies, patients could complete data entry on their own, allowing nurses to focus on higher-order tasks. Kiosks are a popular working example of such self-service technologies; however, placing a sufficient number of unwieldy and fixed machines demands a spatial change in the greeting area and affects pretriage flow. Mobile technologies could offer a solution to these issues.
    OBJECTIVE: The aim of this study was to investigate the use of mobile technologies to improve pretriage flow in EDs.
    METHODS: The proposed stack of mobile technologies includes patient-carried smartphones and QR technology. The web address of the self-registration app is encoded into a QR code, which was posted directly outside the walk-in entrance to be seen by every ambulatory arrival. Registration is initiated immediately after patients or their proxies scan the code using their smartphones. Patients could complete data entry at any site on the way to the triage area. Upon completion, the result is saved locally on smartphones. At the triage area, the result is automatically decoded by a portable code reader and then loaded into the triage computer. This system was implemented in three busy metropolitan EDs in Shanghai, China. Both kiosks and smartphones were evaluated randomly while being used to direct pretriage patient flow. Data were collected during a 20-day period in each center. Timeliness and usability of medical students simulating ED arrivals were assessed with the After-Scenario Questionnaire. Usability was assessed by triage nurses with the Net Promoter Score (NPS). Observations made during system implementation were subject to qualitative thematic analysis.
    RESULTS: Overall, 5928 of 8575 patients performed self-registration on kiosks, and 7330 of 8532 patients checked in on their smartphones. Referring effort was significantly reduced (43.7% vs 8.8%; P<.001) and mean pretriage waiting times were significantly reduced (4.4, SD 1.7 vs 2.9, SD 1.0 minutes; P<.001) with the use of smartphones compared to kiosks. There was a significant difference in mean usability scores for \"ease of task completion\" (4.4, SD 1.5 vs 6.7, SD 0.7; P<.001), \"satisfaction with completion time\" (4.5, SD 1.4 vs 6.8, SD 0.6; P<.001), and \"satisfaction with support\" (4.9, SD 1.9 vs 6.6, SD 1.2; P<.001). Triage nurses provided a higher NPS after implementation of mobile self-registration compared to the use of kiosks (13.3% vs 93.3%; P<.001). A modified queueing model was identified and qualitative findings were grouped by sequential steps.
    CONCLUSIONS: This study suggests patient-carried smartphones as a useful tool for ED self-registration. With increased usability and a tailored queueing model, the proposed system is expected to minimize pretriage waiting for patients in the ED.
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  • 文章类型: Journal Article
    抗体-药物缀合物(ADC)的开发和优化取决于增强的分析和生物分析表征,特别是在评估关键质量属性(CQAs)方面。ADC的效力在很大程度上取决于与单克隆抗体(mAb)连接的药物的平均数量,称为药物抗体比(DAR)。此外,药物负荷分布(DLD)影响ADC的治疗窗口,定义有效治疗疾病而不引起毒性作用的剂量范围。在CQA中,DAR和DLD至关重要;它们的控制对于确保制造一致性和产品质量至关重要。通常,疏水作用色谱(HIC)或带有UV检测器的反相液相色谱(RPLC)已用于定量质量控制(QC)环境中的DAR和DLD。最近,天然尺寸排阻色谱-质谱(nSEC-MS)证明了在研究或早期临床前开发中,作为可平台化的定量方法来表征各种半胱氨酸连接的ADC中的DAR和DLD的潜力。在这项工作中,我们使用台式LC-MS平台建立并评估了简化的nSEC-MS工作流程,定量监测不同化学型和药物负荷水平的半胱氨酸连接ADC的DAR和DLD。此外,要在QC环境中部署此工作流,在三个独立实验室进行了完整的方法验证,遵守国际人用药品技术要求协调理事会(ICH)Q2(R1)指南。结果符合预定义的分析目标概况(ATP)和性能标准,包括特异性/选择性,准确度,精度,线性度范围,定量/检测限,和鲁棒性。最后,方法验证设计为可能用于测定半胱氨酸接头ADC上DAR和DLD的其他nSEC-MS方法提供了参考.据我们所知,本研究是首次报道的用于检测DAR和DLD的nSEC-MS方法的系统验证。结果表明,共同验证的nSEC-MS工作流程适用于ADC质量控制中的DAR和DLD常规分析,释放,和稳定性测试。
    The development and optimization of Antibody-Drug Conjugates (ADCs) hinge on enhanced analytical and bioanalytical characterization, particularly in assessing critical quality attributes (CQAs). The ADC\'s potency is largely determined by the average number of drugs attached to the monoclonal antibody (mAb), known as the drug-to-antibody ratio (DAR). Furthermore, the drug load distribution (DLD) influences the therapeutic window of the ADC, defining the range of dosages effective in treating diseases without causing toxic effects. Among CQAs, DAR and DLD are vital; their control is essential for ensuring manufacturing consistency and product quality. Typically, hydrophobic interaction chromatography (HIC) or reversed-phase liquid chromatography (RPLC) with UV detector have been used to quantitate DAR and DLD in quality control (QC) environment. Recently, Native size-exclusion chromatography-mass spectrometry (nSEC-MS) proves the potential as a platformable quantitative method for characterizing DAR and DLD across various cysteine-linked ADCs in research or early preclinical development. In this work, we established and assessed a streamlined nSEC-MS workflow with a benchtop LC-MS platform, to quantitatively monitor DAR and DLD of different chemotype and drug load level cysteine-linked ADCs. Moreover, to deploy this workflow in QC environment, complete method validation was conducted in three independent laboratories, adhering to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) guidelines. The results met the predefined analytical target profile (ATP) and performance criteria, encompassing specificity/selectivity, accuracy, precision, linearity, range, quantification/detection limit, and robustness. Finally, the method validation design offers a reference for other nSEC-MS methods that are potentially used to determine the DAR and DLD on cysteine-linker ADCs. To the best of our knowledge, this study is the first reported systematic validation of the nSEC-MS method for detecting DAR and DLD. The results indicated that the co-validated nSEC-MS workflow is suitable for DAR and DLD routine analysis in ADC quality control, release, and stability testing.
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