The validation stage establishes that your method operates as intended and is capable of consistently delivering quality data. Efficient automation of the method validation workflow is important to ensure that your data adheres to your validation requirements. Dedicated method validation software improves data traceability and reduces risk associated with data transfer and transcription.
The Stages of Method Lifecycle Management
Methods with greater agility, robustness, and capacity for change can help reduce regulatory burden, failure risk, and costs. Discover the stages, concepts, and terms that define lifecycle management, then explore them in depth below.
Method Performance Qualification in Depth
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.
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.
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.
Automates and streamlines method validation. Empower 3 Method Validation Manager (MVM), an option for Empower 3 Chromatography Software, allows you to perform chromatographic method validation, from protocol planning through final reporting
Validating analytical methods is critical to achieving accurate, consistent, and reliable results. There are multiple challenges during the validation process, from planning the analytical testing protocol, to the calculation of results and comparing against the acceptance criteria. This webinar will help you increase laboratory efficiency for chromatographic method validation, and ensure compliance to the validation requirements and acceptance criteria.
Method validation, a critical part of a method lifecycle, confirms that the developed method is suitable for its intended use. Method validation is time-consuming because of data generation and workup. Method Validation Manager (MVM) with Empower allows you to perform method validations while reducing time and cost as much as 80 percent by eliminating manual steps in your current method validation process.
Empower 3 Software Method Validation Manager is an enterprise option that automates chromatographic method validation. Capabilities include storage of your method validation SOP requirements in Empower 3 Software, so it can automatically guide you through the method validation workflow, calculate method validation results, determine if the data adheres to your SOP requirements.