Analysis Paralysis: Navigating Early-Phase Analytical Validation

By Dustin Lafferty, Singota Solutions

Significant confusion persists across the pharmaceutical/biopharmaceutical industry relevant to early-phase analytical development and validation. While several guidance documents serve as a de facto standard, distinguishing method validation requirements from suggestions, when and how to apply those guidelines often is not a straightforward task.

It is critical to establish a product/project’s analytical life cycle early and to revisit findings throughout a project. Despite working with limited information, method qualification researchers often can gather a significant amount of data on the molecule early in development, thus establishing a method that is specific, accurate, and has good linearity. Moreover, as the project progresses (usually over several years), that library of data will remain as a reference for validation. This way, drug developers can access past analyses to understand and exhibit how well the method has held up during the drug’s life cycle.

With time and experience (i.e., working with the molecule), it is possible to identify pinch points that require optimization (particularly those with significant timeline impacts). This experience also reinforces the method’s robustness because, by full validation, researchers will have prepped solutions multiple times.