Level: Intermediate
Agnieszka Tomczyk, Statistician Specialist, Polpharma Biologics
Stability analysis is a necessary part of biosimilars development. This case study will show how we built, from scratch, a working analytical and reporting tool for stability analysis in JMP. The talk will focus on addressing the real challenges that we face in the stability data gathering and analysis process – from importing data sets to writing a report. The presentation will consider comparing lots, plotting data in different configurations, regression analysis, testing for poolability of batches, analysis of covariance (ANCOVA), outliers analysis and determining shelf life and retest period. Apart from that, we want to provide an insight into our process of building the engine, implementation and spreading across organization. The aim was not to let the analytics get stuck in the statistics department, but to make the tool as user friendly as possible. We want to demonstrate how the organization benefits from the process and saves time, as well as plans for the future and possible improvements.
