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Waters Corporation today announced that its Empower™ Software now supports biologics data acquisition and quality control (QC) analysis from Multi-Angle Light Scattering (MALS) and differential Refractive Index (RI) instruments in its Wyatt Technology™ Portfolio. This integration expands the scope of critical quality attributes that a biopharmaceutical laboratory can manage using Empower Software.
沃特世公司今日宣布,其Empower™软件现已支持从怀雅特科技™产品组合中的多角度光散射(MALS)和差示折射率(RI)仪器进行生物制品数据采集和质量控制(QC)分析。这一集成扩展了生物制药实验室使用Empower软件可以管理的关键质量属性的范围。
Additionally, this advancement will simplify the process and digital footprint of acquiring and submitting compliant data to regulatory authorities – from biologics development through QC – saving customers up to six months of software validation time..
此外,这一进展将简化获取和提交符合监管机构要求的数据的过程及其数字足迹——从生物制品开发到质量控制——为客户节省长达六个月的软件验证时间。
Empower Software is the industry's most established and compliant-ready chromatography data system (CDS), widely adopted globally and used to submit data for more than 80% of novel drugs to regulatory authorities.4 The new integration unlocks the ability to use MALS techniques in quality control for biotherapeutics, improving efficiency and Good Manufacturing Practices (GMP) readiness, while reducing end-user training in compliant settings..
Empower软件是业界最成熟且合规的色谱数据系统(CDS),在全球范围内被广泛采用,并用于向监管机构提交超过80%的新药数据。新的集成解锁了在生物治疗药物的质量控制中使用MALS技术的能力,提高了效率和良好生产规范(GMP)的就绪性,同时减少了在合规环境中的最终用户培训需求。
'Today's launch of Empower for Multi-Angle Light Scattering Detectors underscores our commitment from the Wyatt acquisition to integrate advanced analytical technologies into our Empower CDS ecosystem,' said Dr. Udit Batra, President & CEO, Waters Corporation. 'Specifically, MALS supported on Empower Software reveals high molecular weight species that are not visible to other detectors – reducing the risk of erroneous results in biotherapeutic quality control.
“今天推出的Empower多角度光散射检测器再次彰显了我们从怀雅特收购案以来,对将先进分析技术整合到我们的Empower CDS生态系统中的承诺,”沃特世公司总裁兼首席执行官Udit Batra博士说道。“具体来说,支持Empower软件的MALS能够揭示其他检测器无法检测到的高分子量物质,从而降低生物治疗质量控制中出现错误结果的风险。”
By combining the strengths of compliant software with deep analytical light scattering instrumentation, we are providing customers with a unified solution that enhances productivity and data accuracy – ultimately supporting high-volume QC testing to ensure the safety of life-saving biologic therapies for patients.'.
通过将合规软件的优势与深度分析光散射仪器相结合,我们为客户提供了一个统一的解决方案,提高了生产效率和数据准确性——最终支持高通量质量控制测试,以确保患者使用的救命生物疗法的安全性。
The integration of the DAWN™, miniDAWN™, and OptiLab™ Detectors will enable the measurement of more critical quality attributes of peptides and proteins in a single run, reducing analysis time by 20% and providing earlier insights into the stability, safety, and efficacy of biologics.
DAWN™、miniDAWN™ 和 OptiLab™ 检测器的集成将能够在一个运行中测量多肽和蛋白质的更多关键质量属性,减少20%的分析时间,并提供关于生物制品稳定性、安全性和有效性的更早见解。
'As a Contract Development and Manufacturing Organization (CDMO), we anticipate that MALS on Empower Software will enhance our service offerings,' said William Wittbold, Senior Director of Operations, at Pace Analytical. 'The detailed MALS data is essential for understanding complex biotherapeutics.
“作为合同开发和制造组织 (CDMO),我们预计Empower软件上的MALS将提升我们的服务能力,”Pace Analytical运营高级总监William Wittbold表示,“详细的MALS数据对于理解复杂的生物治疗药物至关重要。”
Combined with the reliability of Empower Software, we believe this integration will deliver exceptional value to our customers, ensuring our drug development partners receive the highest quality results.'.
结合Empower软件的可靠性,我们相信此次整合将为我们的客户带来非凡的价值,确保我们的药物开发合作伙伴获得最高质量的结果。
The capability to integrate the DAWN, miniDAWN, and OptiLab Detectors with Empower Software will be available for peptide and protein workflows in July 2025. Learn more by visiting our product page.
2025年7月,将提供与Empower软件集成DAWN、miniDAWN和OptiLab检测器的功能,适用于肽和蛋白质工作流程。请访问我们的产品页面了解更多信息。
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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.
沃特世公司(纽约证券交易所代码:WAT)是分析仪器、分离技术和软件的全球领导者,65年来一直服务于生命科学、材料科学、食品科学和环境科学领域。我们公司助力确保药品的有效性、食品的安全性、水的纯净度,以及日常使用产品的质量和可持续性。
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..
在100多个国家,我们7600多名充满热情的员工与实验室、制造基地和医院的客户合作,加速开创性科学带来的益处。
Waters, Empower, DAWN, miniDAWN, OptiLab, and Wyatt Technology are trademarks of Waters Technologies Corporation.
Waters、Empower、DAWN、miniDAWN、OptiLab 和 Wyatt Technology 是 Waters Technologies Corporation 的商标。
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Molly Gluck
莫莉·格拉克
Head of External Communications
外部通讯主管
Waters Corporation
沃特世公司
molly_gluck@waters.com
molly_gluck@waters.com
Mobile: +1.617.833.8166
手机:+1.617.833.8166
Source: waters.com
来源:waters.com