REI-EXCISE is a multicentre, prospective, non-randomised feasibility study, aimed to evaluate the diagnostic accuracy of rapid ionisation mass spectroscopy using an iKnife device. The iKnife will collect vapour, a by-product of surgery, which will pass through the mass spectrometer machine for analysis in order to evaluate what is "normal" and what is "cancerous" breast tissue.

开始日期2017-09-05

申办/合作机构

Imperial College London

[+2]

100 项与 Waters Corp. 相关的临床结果

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0 项与 Waters Corp. 相关的专利（医药）

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2,265

项与 Waters Corp. 相关的文献（医药）

2025-06-01·European Journal of Pharmaceutical Sciences

Selected new approaches and future perspectives in liquid chromatography for the analysis of emerging modalities

Review

作者: Gritti, Fabrice ; Imiołek, Mateusz ; Fekete, Szabolcs ; Xu, MingCheng ; Addepalli, Balasubrahmanyam ; Lauber, Matthew

Emerging biopharmaceutical modalities, such as genetic medicines and RNA therapies, offer transformative potential for treating previously intractable diseases. However, these complex drugs present unique analytical challenges due to their intricate structures, sophisticated manufacturing processes, and modality-specific product quality attributes. Liquid chromatography (LC) has emerged as a versatile tool for addressing these challenges, enabling precise characterization and quality control strategies. This review highlights recent advancements in LC technologies, including low-adsorption hardware, ultra-wide pore size exclusion chromatography (SEC) columns, and innovative separation modes such as slalom chromatography and pressure-enhanced liquid chromatography (PELC). These developments tackle issues such as non-specific adsorption, carryover, and inadequate selectivity while improving resolution and robustness for large biomolecules like mRNA, adeno-associated viruses (AAVs), and lipid nanoparticles (LNPs). Novel approaches, such as tandem SEC systems, gradient SEC columns, and dual stationary phase gradients, further expand the scope of LC techniques by enhancing separations for diverse analyte sizes and complexities. Additionally, practical innovations like bracketed injection methods and new enzymatic tools for oligo-mapping improve reproducibility, efficiency, and confidence in RNA sequence analysis. These advancements not only address current analytical limitations but also pave the way for regulatory-compliant approaches, which will support the broader adoption of LC in both discovery and quality control settings. As the field continues to evolve, these innovations are poised to play a pivotal role in ensuring the safety, efficacy, and consistency of next-generation therapeutics.

2025-06-01·Analytica Chimica Acta

Systematic method optimisation approach for small molecule imaging on the SELECT SERIES MALDI MRT - Drug mapping in fingerprints, a case study

Article

作者: Cole, Laura ; Bradshaw, Robert ; Krishna, Rohith ; Langridge, James ; Claude, Emmanuelle ; Francese, Simona

Molecular fingerprinting via Matrix Assisted Laser Desorption Ionisation time-of-flight Mass Spectrometry profiling (MALDI MSP) and Imaging (MALDI-MSI) has been proven to provide biometric and lifestyle information from a fingermark. As such, it can be an effective tool to assist police investigations, thus justifying continued effort to improve the quality and range of the forensic intelligence that it is possible to provide. We are currently exploring the advancements in molecular fingerprinting capabilities on the state-of-the -art SELECT SERIES MALDI-MRT mass spectrometer based on its high mass measurement accuracy (sub-ppm) and spatial resolution (15 μm). The unique nature of this instrument requires careful optimisation to maximise the system's performance for the imaging of small molecules in fingerprints. In this study, a systematic approach to setting optimisation including optimisation of laser parameters, source voltage, quadrupole MS profile, and Transfer gas as well as RF voltage settings were determined for the analysis of latent fingerprint imaging and antipsychotics-contaminated fingerprint imaging. The developed method eventually yields significant improvement in image resolution over the default parameters.

2025-05-01·Journal of Chromatography A

Enhancing pyrrolizidine alkaloid separation and detection: LC-MS/MS method development and integration of ion mobility spectrometry into the LC-HRMS workflow

Article

作者: Carbonell-Rozas, Laura ; Dreolin, Nicola ; Dall'Asta, Chiara ; Foddy, Henry

Pyrrolizidine alkaloids (PAs) are plant toxins occurring in different foodstuffs, including teas, herbal infusions and species. Additionally, PAs may be transferred to honey and pollen when honeybees come into contact with contaminated plants. Due to their adverse effect, PAs occurrence in food must be controlled to ensure public health. Nevertheless, the presence of numeours PA epimers complicates their chromatographic separation and detection. In this regard, a method using liquid chromatography coupled with tandem mass spectrosmetry (LC-MS/MS) has been developed allowing the separation of 31 out of the 35 regulated PAs, which was sucessfully validated in different food matrices such as herbal infusions, spices and honey. Afterwards, travelling wave ion mobility spectrometry hyphenated with quadrupole time-of-flight mass spectrometry (TWIMS-QTOF) was evaluated to improve the analytical performance of PAs determination. Thus, collision cross section (CCS) values of PAs have been therefore obtained for the first time. The CCS library for PAs was also compared with predicted values by machine learning and with those meassured in real food matrices (bias <2 %). In addition, an in-house library was used in the suspect screening of PAs to complement the targeted analysis of the studied samples, all of which tested positive for several PAs.

138

项与 Waters Corp. 相关的新闻（医药）

2025-04-01

·PRNewswire

Waters Expands Alliance iS Bio HPLC Product Line with Photodiode Array Detector to Enhance Spectral Insights for Biopharma Development & QC

News Summary Boosts out-of-the-box sensitivity by up to 80 times with MaxPeakTM Premier columns.1 Delivers over threefold improvements in day-to-day reproducibility2 and decreases carryover by up to two orders of magnitude.3 Reduces common user errors by up to 40%.4 MILFORD, Mass., April 1, 2025 /PRNewswire/ -- Waters Corporation (NYSE:WAT) today announced the expansion of the Alliance™ iS Bio HPLC product line with integrated photodiode array (PDA) detection, advancing the capabilities of the next-generation intelligent HPLC platform designed for development and Quality Control (QC) laboratories. Continue Reading The new Waters Alliance iS Bio HPLC System with integrated PDA Detector combines advanced bioseparation technology with built-in instrument intelligence to enhance flexibility, operational efficiency, performance, and ease of use in biopharma quality control (QC) laboratories "The addition of the Alliance iS Bio HPLC System with PDA detection allows biopharmaceutical laboratories to perform enhanced spectral analysis, including impurity detection, peak purity analysis, multi-wavelength detection, and method validation, to deliver safe and effective products," said Fraser McLeod, Vice President, General Manager, QA/QC, at Waters Corporation. "Built on the Alliance iS HPLC Platform, the system is designed to simplify the analysis of complex biopharmaceuticals in development and QC, reduce errors, and improve accuracy and operational efficiency." The Alliance iS HPLC Platform has been purposefully designed to simplify laboratory workflows by reducing the risk of out-of-specification results and the need for troubleshooting. Default system parameters provide over threefold improvement in day-to-day reproducibility2 and reduce carryover by up to two orders of magnitude,3 compared to other systems on the market. Additionally, with MaxPeak Premier columns, the Alliance iS Bio HPLC System enhances out-of-the-box sensitivity by up to 80 times compared to traditional systems and columns.1 Waters now offers four configurations of the Alliance iS HPLC Platform to support routine quantitative analysis and expanded spectral analysis of small and large molecules in development and QC. All configurations are controlled by the compliance-ready Waters EmpowerTM Chromatography Data System, which enables laboratories to collect, manage, and report chromatography test results. The platform also supports connectivity with laboratory information management systems (LIMS) to help high-volume QC labs manage operational risk, mitigate disruptions, and increase overall productivity. The Alliance iS HPLC Platform has earned the Accountability, Consistency, and Transparency (ACT) Ecolabels from My Green Lab, a nonprofit organization dedicated to building a global culture of sustainability in science. Notably, the product line was recognized for its sustainable manufacturing practices and innovative error-reducing design, underscoring the commitment of Waters to reducing the most significant environmental impacts. The Waters Alliance iS Bio HPLC System with PDA detection is available for order now. Additional Resources: See detailed specifications and configurations: Waters Alliance iS Bio HPLC System Watch the Alliance iS Bio HPLC System Video Watch the Webinar Replay Follow and connect with Waters LinkedIn, Twitter, and Facebook About Waters Corporation () Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science. Contact: Janice Foley Senior Public Relations Manager, Corporate Communications Waters Corporation [email protected] Mobile: +1.617.823.5555 Photo - Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025-03-03

·美通社

沃特世与科华生物联合推出两款国产液质联用IVD系统，赋能中国临床诊疗高质量发展

沃特世与科华生物联合推出两套国产LC-MS/MS IVD系统，已获得中国药监部门批准。所提供的完整分析解决方案，可适用于多种临床检测需求，帮助临床医生提高诊断和治疗的准确性和效率。这是沃特世在临床领域深化本土合作与创新的又一重要举措。上海 2025年3月3日 /美通社/ -- 沃特世公司（纽约证券交易所代码：WAT）日前与上海科华生物工程股份有限公司（股票代码：002022.SZ，以下简称"科华生物"）在上海共同举办了新品发布会，联合推出两款应用于体外诊断（IVD）领域的国产液相色谱串联质谱（LC-MS）系统：ACQUITY TM UPLC I-Class PLUS / Xevo TM TQ-Loong TM System和ACQUITY TM UPLC I-Class PLUS/ Xevo TM TQ-S cronos System。两套系统均已获得中国药监部门批准，将于本月正式上市。两款新系统的推出是沃特世在临床领域的又一重要举措，旨在满足国内临床实验室对先进检测技术的迫切需求，助力构建更加完善的医疗检测体系。与会嘉宾代表为新品揭幕（左起：沃特世临床事业部大中华区总经理洪军，上海交通大学转化医学研究院副院长孙洁林，上海交通大学副校长曾小勤，科华生物董事长、总裁李明，沃特世临床研发副总裁Mikko Koskinen，上海交通大学转化医学研究院樊春海院士，上海交通大学转化医学研究院书记张显明，科华生物高级副总裁陈超）这两款系统被批准在临床上用于对人体生物样本（全血、血浆、血清、尿液）的内源（维生素、氨基酸、激素、有机酸）或外源（治疗药物）被分析物进行定性或定量检测。其中，ACQUITY UPLC I-Class PLUS / Xevo TQ-Loong系统可满足要求严苛的UPLC-MS/MS定量分析，其出色的性能可在复杂的临床基质中准确定量痕量分析物，为临床研究提供更精准的数据支持。另一款ACQUITY UPLC I-Class PLUS/ Xevo TQ-S cronos系统则性能稳定并极具性价比，可充分满足临床实验室中的常规定量分析。两款产品将帮助中国客户有效应对临床研究与诊断实验室多样化的分析需求。沃特世全球高级副总裁Jianqing Bennett表示："此次与科华生物的战略合作，体现了沃特世对临床市场的关注，以及为满足全球患者和医生所需提供先进分析技术的承诺。联合推出的液质联用IVD系统深度融合了双方在分析仪器和体外诊断领域的技术优势，旨在通过打造"自动化、智能化、整体化"的完整解决方案，提升临床实验室检测效能，优化诊疗决策。沃特世将持续推进本土合作与创新，深化与中国合作伙伴的协同，为患者提供更精准、更可及的诊疗服务。" 科华生物董事长、总裁李明表示："科华生物与沃特世公司通过优势互补与创新协同，联合推出双品牌高端串联质谱仪，创建了全新的整体解决方案，将有效提升临床诊疗水平，赋能医疗服务体系升级。此次战略合作，是双方拓展全球化合作模式的一次积极尝试。未来，我们期待以更多的国际化合作，将技术积累、智造优势与全球创新资源深度融合，为体外诊断行业的高质量发展树立新标杆，创造新动能，也为促进全球健康事业发展贡献力量。" 在联合推出的LC-MS/MS IVD系统基础之上，沃特世与科华生物通过优势整合，共同打造了涵盖自动化前处理系统和检测试剂盒的临床质谱分析整体解决方案。该解决方案可应用于营养/药物浓度监测、内分泌激素、生物标志物、临床毒理、临床科研等多元化场景，为临床医生简化操作、提升效率的同时，确保检测结果的准确性。未来，沃特世与科华生物将继续深化合作，立足临床实验室的实际需求，通过技术创新与应用开发的深度融合，为提升精准诊疗水平注入新的动力，增进前沿科技对患者的惠益。其他参考资料：了解更多沃特世临床解决方案，欢迎访问：沃特世临床研究与诊断。关于沃特世公司（ www.waters.com ）沃特世公司（纽约证券交易所代码：WAT）是居于全球前列的分析仪器、分离技术和信息学软件供应商，服务于生命科学、材料科学、食品及环境科学等领域已逾65年。沃特世致力于确保药物的有效性、食品的安全性、水的纯净度以及日常用品的质量和可持续性。在全球 100 多个国家和地区，我们拥有7500 多名满怀热忱的员工，与实验室、生产工厂和医院的客户展开广泛合作，增进前沿科学的惠益。关于沃特世中国自上世纪80年代进入中国以来，沃特世的规模与实力与日俱增，在中国大陆的上海、北京、广州以及香港、台湾地区均设有运营中心和实验中心。凭借在中国市场的深远布局及斐然成就，今天的中国已成为沃特世全球营收仅次于美国的第二大市场。 ACQUITY 、 Xevo 、 TQ-Loong 均为沃特世科技公司的商标。关于科华生物（ www.skhb.com/cn/ ）上海科华生物工程股份有限公司创建于1981年，2004年在深圳证券交易所中小板上市，是一家集研发、生产、销售于一体，有丰富生产经验和完整医疗诊断产品梯队的体外诊断公司。科华生物总部位于上海，在意大利、深圳、西安、苏州等国家和地区设有研发和生产基地，现有员工近2000名。科华生物以研发创新为核心驱动力，打造临床体外诊断试剂和全自动检测分析仪器两大研发技术平台，实现诊断试剂和仪器的"系列化"和"一体化"，以"关爱生命、追求卓越"为企业使命，以成为IVD领域的中流砥柱为企业愿景，坚持"客户至上、创新、协作、责任、务实"的企业价值观，聚焦体外诊断领域，专注创新，精益管理，致力于为人类的健康事业做出贡献。媒体联系方式沃特世公司钱洁 + 86 21 6156 2644 Jackie_qian@waters.com

免疫疗法临床研究

2025-01-10

·贝壳社

专注色谱材料，今日它正式登陆科创板

▲点击图片，了解详情作者：黄仲平今日，赛分科技（688758）正式登陆科创板，发行4998万股，发行后总股本约4.16亿股，发行价4.32元/股，开盘涨幅超5倍。在生物医药产业链这个万亿级别的市场中，医药市场所占比例并非大头，上游的研发才是真正的大市场。CXO首先得到了飞跃，而在CXO的更上游，是各类耗材和原料。在产业链不断完善的局面下，近两年来，这类处于上游的上游企业，正在逐渐走上时代的舞台。赛分科技便是这类企业之一。 1 专注色谱材料近年来生物医药的大跨越发展，为上下游产业带来了巨大的机遇。赛分科技致力于研发和生产用于药物分析检测和分离纯化的液相色谱材料。核心产品为应用于生物大分子药物及小分子化学药物分析检测和分离纯化的色谱柱和色谱填料。该类产品贯穿药物开发生产的全过程，应用于药物研发、IND申报、临床试验、申请上市、商业化生产等多个环节，是制药企业特别是生物药企从药物早期研发到商业化大规模生产所需要的关键核心耗材。 2021-2023年，赛分科技总营收分别为1.55亿元、2.13亿元和2.45亿元；净利润分别为2162.02万元、4820.24万元和5415.39万元。其主要产品为色谱柱和色谱填料，根据应用可划分为分析色谱和工业纯化两大领域。分析色谱材料的微球粒径通常为10微米及以下，主要用于药物的研发分析、质量控制和小量样品的制备，实现对不同组分的分离。根据色谱材料微球的粒径、孔径、官能团、表面修饰技术的不同，以及柱管的材质、直径和长度的不同，可制得不同规格的色谱柱，以满足不同药物分子的分离需求。 2021-2023年，赛分科技的分析色谱业务板块营收分别为9373.22万元、1.1亿元和1.15亿元。工业纯化色谱填料（又称“层析介质”）的微球粒径通常为10微米以上，主要在药物的临床研究阶段以及工业化生产阶段用于分离纯化，实现目标成分的提取，工业纯化类色谱产品形态多为散装层析介质，便于药企大规模纯化使用。赛分科技的层析介质产品体系已超过100种。 2021-2023年，赛分科技的工业纯化板块业务营收分别为5838.09万元、9800.23万元和1.26亿元。产能方面，赛分科技的扬州生产基地于2021年正式投产，一期工程年产达24760升，单批次产能达500升，是国内色谱介质行业具有大规模量产能力的少数企业之一。作为一个生物医药上游极为细分的一个领域，这个市场能达到怎样的规模呢？ 2 成长空间巨大要了解赛分科技所处行业的市场规模，首先要了解生物医药产业链的成本占比。生物药生产包括上游发酵及下游工业纯化。下游纯化环节在整个生物药生产中占据主要生产成本，以单抗为例，下游分离纯化环节占据总生产成本的65%以上。下游分离纯化主要涉及收获、层析捕获、低PH病毒灭活及深层过滤、层析、除病毒过滤、浓缩超滤、无菌过滤等环节，层析是整个下游纯化工艺的核心环节，层析使用的设备及耗材主要为层析系统和色谱填料。生物药分离纯化流程示意图，来源：招股书根据前瞻产业研究院数据，2023年，色谱介质市场方面，中国生物药色谱介质市场规模约为73亿元，未来5年我国生物药色谱介质市场仍将保持高速增长，预计于2026年达到132亿元；同期，在色谱柱市场方面，中国色谱柱产量达到19.8万根，占全球色谱柱产量比例为4.6%，中国色谱柱市场规模达到16.2亿元，未来随着下游领域的需求驱动以及进口替代趋势的进一步增强，2025年中国色谱柱产量预计达到22.9万根，中国色谱柱市场规模预计达到20.7亿元。赛分科技所处行业的竞争格局又是如何？长期以来，全球色谱柱和色谱填料大部分市场被大型跨国科技公司所占据，海外的大型公司由于进入该领域较早，其产品技术优势和应用成熟度较高，在高端市场优势尤为明显。全球范围内主流的分析色谱企业为Thermo Fisher、Agilent、Tosoh和Waters等，这些跨国巨头可以提供包括设备、仪器、试剂、耗材和实验室整体解决方案的一整套生物技术研究开发的工具服务，在产品性能、渠道、客户粘性等方面具有较大的优势，全球的市场份额占比较高。在工业纯化领域，由于技术壁垒较高且需要企业具有规模化生产能力，因此行业集中度较高，Cytiva、Merck KGaA、Thermo Fisher、Tosoh和Bio-Rad等海外企业占据了全球工业纯化填料的主要市场份额，形成了寡头垄断局面。赛分科技凭借20余年的深耕，在分析色谱领域拥有全面的分析色谱品类布局和丰富的可选粒径、孔径维度，产品覆盖度处于行业领先水平；在工业纯化产品方面，基质种类、孔结构、高端产品等均实现了全面的布局，产品覆盖度达到了同等甚至优于同行业公司的水平。赛分科技近年营收组成，来源：招股书这其中，在复合模式色谱柱领域，赛分科技是国际上少有的可以实现生产体积排阻+疏水复合模式色谱柱的企业，自主研发的Biomix系列双抗错配色谱柱已经作为关键技术型耗材，广泛应用于双特异性抗体项目的研发中。并且，赛分科技还是行业内少数同时具备分析色谱及工业纯化领域研发及规模化大生产能力的企业之一。其在全球分析色谱领域客户超过5000家，与包括罗氏、辉瑞、礼来、甘李药业、正大天晴、齐鲁制药、再生元、Moderna等国际大型医药集团、生物制药公司以及创新药企业建立了良好的业务合作关系，并与Agilent、Sigma-Aldrich等行业国际巨头保持长期稳定合作。 2023年，赛分科技国内分析色谱市场占有率约为5.16%，工业纯化（色谱介质）市场占有率约为1.02%，生物大分子色谱介质市场占有率约为1.20%。从市占率数据看，虽然与海外龙头企业相比仍存在较大差距，但从另一个角度也说明，国产替代的空间巨大。 3 结语色谱柱作为液相色谱的心脏，对色谱仪器的应用起到决定性作用，而纯化填料作为生物药生产下游最重要的耗材之一，对生物药质量及生产效率至关重要。在轰轰烈烈的国产化替代浪潮之下，赛分科技登陆资本市场后，或许将大有可为。后续发展如何，贝壳社还将持续关注。参考资料： 1、赛分科技招股书 2、《色谱填料企业赛分科技科创板IPO过会高瓴复星创富国药二期等投了》，科创板日报，2024-1-12 3、《过会7个月后色谱填料企业赛分科技科创板IPO注册生效盈利能力等被重点问询》，科创板日报，2024-8-23 关于贝壳社贝壳社是国内领先的医健创新创业服务平台，为医健创业者提供全路径创业服务。通过产业空间运营、创业教育、投资孵化、数字化赋能、企业价值增长等服务体系，给医健创业企业提供产业空间、人才战略培养、投融资、产业生态资源、数字化转型等服务。同时，贝壳社布局澳洲，帮助国内生物医药企业加速走向海外；成立“泰格-泰珑-贝壳社企业经营服务中心”为企业成长提供全生命周期的增值服务，提高企业运营效率，加快企业成长发展。我们深度链接政府、科研院所、临床机构、投资机构、第三方服务商、CXO等行业资源，致力于赋能医疗健康创业公司成长，推动创新技术造福人类生命健康。往期推荐 1 复星医药：能否踏上复兴征途？ 2 CNS新药即将迎来大爆发时代 _ 3 越来越多Biotech发起“独立宣言” _ *声明：本文仅为作者观点，不构成任何投资建议，且非治疗方案推荐。投稿请添加小助手：bioclub666

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