CADET-Hub: Online platform for biomanufacturing modeling and stability testing

Abstract

Biomanufacturing increasingly relies on computational modeling to strengthen process understanding, speed up process development, scale-up and scale-down, improve experimental design, and reduce reliance on costly and laborious wet lab activities. Here we present CADET-Hub, a modular web-based platform for biomanufacturing and stability modeling, developed within the Inno4Vac project. CADET-Hub unifies upstream and downstream bioprocess modeling with stability prediction in a single, user accessible environment. The upstream modules comprise compartment models derived from computational fluid dynamics and metabolic models for bioreactor simulation. The downstream modules cover centrifugation, filtration, and chromatography, implemented through the open-source bioprocess simulation engine CADET-Core and its workflow and model-building layer CADET-Process. A dedicated stability forecasting module completes the platform by enabling shelf life prediction of biological products using advanced kinetic and statistical methods. Throughout the project, we engaged with regulatory bodies to inform model development, validation, and documentation in line with current regulatory expectations for biopharmaceutical applications.