Presentation
Informatics Approaches to Stability-Indicating Method Development
Joe DiMartino, Solution Area Manager, Luminata; ACD/Labs
Joe DiMartino
During drug development, considerable effort is invested in chromatographic method development and forced degradation studies that support stability-indicating methods. Traditional communication pathways and general-purpose tools limit scientists’ ability to integrate structural, analytical and process knowledge in a scientifically robust manner.
This rapid-fire talk will demonstrate how analytical and material-study data can be captured in a structured, searchable manner, supported by advancements in chromatographic-modelling technology. Luminata® provides a chemically intelligent environment that connects observed degradants with LC/UV/MS results, process metadata and impurity relationships to support more confident interpretation of stress-testing outcomes.
ACD/Labs chromatography software combines predictive retention modelling, simulation-based robustness assessment, automated peak tracking and method-database mining to assess historical stability-indicating performance. Together, these capabilities create a data-driven triage framework that helps scientists distinguish relevant degradants, optimize separation strategies and strengthen decision-making in stability-indicating method development.
This combined approach represents a meaningful advancement in how degradants are evaluated and stability-indicating methods are scientifically justified.
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