第2階段:方法效能驗證

驗證階段能證明您的方法運作正常,能夠始終提供優質數據。自動處理方法驗證工作流程並發揮效率,是保障數據完全遵守驗證要求的重要條件。專用的方法驗證軟體能加強數據稽核追蹤功能,也能降低數據轉移與謄寫過程造成的風險。

MLCM Graph

深入瞭解方法效能驗證

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.

影片/網路研討會
Empower方法驗證管理程式

自動處理並簡化方法驗證流程。Empower 3方法驗證管理程式(MVM)是Empower 3層析軟體的一項選擇,可用於執行從實驗步驟規劃到最終報告的層析方法驗證

影片/網路研討會
使用Empower在遵循法規的環境中簡化方法驗證流程

分析方法驗證是決定結果準確度、一致性與可靠性的重要關鍵。從規劃分析測試實驗步驟到計算結果與對照驗收準則,驗證過程會經歷許多挑戰。本網路研討會能協助您提升實驗室的層析方法驗證效率,也能讓您確實遵循驗證要求與驗收準則。

應用手冊/技術簡報
運用Empower 3 MVM軟體提升鹽酸甲氧氯普胺及相關物質的方法驗證效率
善用軟體省時省錢

方法驗證是方法生命週期階段的重要關鍵,用途在於確認開發出來的方法是否適合其預定用途。方法驗證過程相當耗時,這是由於需要產生及處理數據的緣故。Empower內建方法驗證管理程式(MVM),讓您在執行方法驗證之餘,還能屏除現階段方法驗證流程的人工處理步驟,從而縮短時間並省下高達80%的成本。

手冊
Empower 3軟體方法驗證管理程式

Empower 3軟體方法驗證管理程式是企業版選項,用途是能自動處理層析方法驗證。其功能包括將方法驗證SOP要求儲存在Empower 3軟體中,軟體會自動引導您完成方法驗證工作流程、計算方法驗證結果,以及判斷數據是否符合要求。