id author title date pages extension mime words sentences flesch summary cache txt cord-032403-9c1xeqg1 Sokolov, Michael Decision Making and Risk Management in Biopharmaceutical Engineering—Opportunities in the Age of Covid-19 and Digitalization 2020-09-08 .txt text/plain 4107 212 36 10 The main engineering challenges 9,11−13 are to (1) robustly control the behavior of the living organism involved in the process, (2) efficiently align the often heterogeneous data generated across different process units and scales, (3) include all available prior know-how and experience into the decision process, (4) reduce human errors and introduced inconsistency, and (5) enable an automated and adaptive procedure to assess the critical process characteristics. Because of significant time pressure in development and risk mitigation pressure in manufacturing, decisions are often made on an ad hoc basis involving expert meetings where all readily available data, analysis results, and experience sources are taken into account without ensuring consideration of all possible available information hidden in the databases or inside the potential of (not automatedly retrained or connected) predictive models. However, in manufacturing operations which are based on Industrial & Engineering Chemistry Research pubs.acs.org/IECR Commentary decisions either actively introduced or supported by such models, a detailed assessment of these smart digital solutions is required. ./cache/cord-032403-9c1xeqg1.txt ./txt/cord-032403-9c1xeqg1.txt