摘要:AbstractCommercial biopharmaceutical manufacturing comprises of multiple distinct processing steps that require effective and efficient monitoring of many variables simultaneously in real-time. This article addresses the problem of real-time statistical batch process monitoring (BPM) for biopharmaceutical processes with limited production history; herein, referred to as the ‘Low-N’ problem. In this article, we propose an approach to transition from a Low-N scenario to a Large-N scenario by generating an arbitrarily large number ofin silicobatch data sets. The proposed method is a combination of hardware exploitation and algorithm development. To this effect, we propose a Bayesian non-parametric approach to model a batch process, and then use probabilistic programming to generate an arbitrarily large number of dynamicin silicocampaign data sets. The efficacy of the proposed solution is elucidated on an industrial process.