Use of Bayesian Modeling for Risk Assessment and Robustness Evaluation

• DOI: 10.1021/acs.oprd.3c00325
• Publication Date: 2024-01-29T09:32:03Z
• Authors: Adam J. Freitag; Amanda J. Rogers; Jose E. Tabora; Daniel S. Treitler
• Keywords: Robustness

The definition of a robust control strategy is critical to ensuring quality in the manufacture active pharmaceutical ingredients (APIs). This publication provides case study wherein Bayesian probabilistic modeling was used evaluate process risk exceeding permitted level for impurity deucravacitinib drug substance (DS). Formation and purging this were studied via Design Experiments (DoE) univariate investigation reaction crystallization parameters. models generated predict performance assess predicted failure rates at target parameter set points as well across multivariate space. analysis confirmed designation (CPP) provided knowledge on high-risk conditions. also enabled estimation impact common cause plant variability anticipated rate given specification impurity.