第2阶段:方法性能评估

验证阶段可证明方法按照预期运行,并且可以始终提供高质量数据。有效实现自动化方法验证工作流程非常重要,能够确保数据符合验证要求。专用的方法验证软件可以提高数据可追溯性,减少数据传输和抄录过程中的有关风险。MLCM Graph

深入了解方法性能评估

App notes / Tech briefs
Impact of Instrument Characteristics on Reversed Phase Chromatography Method Transfer Across Biocompatible UHPLC Systems
Impact of Instrument Characteristics on Reversed Phase Chromatography Method Transfer Across Biocompatible UHPLC Systems

Biopharmaceutical companies often need to transfer analytical liquid chromatography (LC) methods within their own organization and/or to external contract organizations. Among these LC methods, reversed phase (RP), size-exclusion chromatography (SEC), and ion exchange (IEX) are commonly used to characterize biomolecules. Biocompatible or bio-inert LC systems are frequently chosen for SEC and IEX analysis due to conditions requiring aqueous mobile phase with high salt concentrations. The materials used to build biocompatible or bio-inert LC systems typically include MP35N, a nickel-cobalt alloy, titanium, or polyether ether ketone (PEEK), just to name a few. Those materials can reduce potential corrosion from high salt concentration and avoid oxidation of the protein by the presence of iron ions. In many cases, the same LC systems would be employed for RP analysis as well.

Publications & Whitepapers
Dwell Volume and Extra-Column Volume: What Are They and How Do They Impact Method Transfer?
Dwell Volume and Extra-Column Volume: What Are They and How Do They Impact Method Transfer?

A chromatographic separation is impacted by numerous factors, including the LC system and its characteristics. The impact of the chromatographic system on the separation may not be obvious until the method is transferred to another LC system or scaled to a different column dimension. By characterizing the system and understanding these differences, strategies can be undertaken to increase the success of methods transfer. These approaches can use software or hardware tools – including the ACQUITY™ instrument control software – or follow the USP <621> Chromatography guidelines for scaling to translating methods.

Blogs / Articles
Method Lifecycle Management Strategies Pave the Way for Greater Procedure Understanding and Fewer Transfer Failures
Method Lifecycle Management Strategies Pave the Way for Greater Procedure Understanding and Fewer Transfer Failures

In recent years, the increased number of method transfer failures has led to greater transfer scrutiny by industry and regulators. And for good reason. Simple paper transfers between sending and receiving units and provision of ambiguous information are widely regarded as insufficient. These outdated practices are now being superseded by more proactive approaches to support successful method transfer, including the provision of method transfer packages and improved lab-to-lab communication.

视频/网络研讨会
Empower方法验证管理器

自动化和简化方法验证工作流程。Empower 3方法验证管理器(MVM)是Empower 3色谱软件的选件,让您能够实施从方案规划到最终报告的色谱方法验证

视频/网络研讨会
使用Empower软件在合规环境下简化方法验证流程

要获得准确、一致、可靠的数据,必须对分析方法进行验证。从规划分析测试方案、计算结果,到与可接受标准进行对比,验证过程中会面临诸多挑战。本次网络研讨会将帮助您提高实验室的色谱方法验证效率,确保符合验证要求和可接受标准。

应用纪要/技术简报
利用Empower 3 MVM软件提高盐酸甲氧氯普胺及相关物质的方法验证效率
使用软件节约时间和成本

方法验证是方法生命周期的关键一环,可以确认开发的方法适用于其预期用途。由于需要生成数据并进行处理,方法验证非常耗时。方法验证管理器(MVM)结合Empower软件,免除了当前方法验证过程中的手动步骤,使方法验证时间和成本减少多达80%。

产品手册
Empower 3软件方法验证管理器

Empower 3软件方法验证管理器是企业版的一个选件,可以自动进行色谱方法验证。该选件能够在Empower 3软件中存储方法验证SOP,因此可以自动引导您完成方法验证工作流程,计算方法验证结果,并确认数据是否符合SOP要求。