This presentation will compare the production of Fibroblast Growth Factor-2 (FGF2) using two microbial hosts with distinct bioprocess characteristics, necessitating different strategies for process optimization. This talk will provide the audience with a practical framework for selecting and optimizing microbial hosts for growth factor production based on their intrinsic biological and bioprocess characteristics. The presentation will also demonstrate how kinetic modeling can be directly translated into operational decisions for continuous and perfusion cultures, and how advanced fermentation strategies such as chemostat-filtration coupling and cascade fermentation can be used to overcome metabolic burden and stability limitations. These concepts will be broadly applicable to the continuous manufacturing of recombinant proteins for biopharmaceutical, cultivated meat, and serum-free media applications.

A digital shadow is a near–real-time, data-driven virtual representation of a bioreactor and its process. An AI-augmented digital shadow (AIS) accelerates process intensification by integrating multivariate data with machine-learning and hybrid mechanistic models to identify actionable parameters and nonlinear interactions. AIS enables what-if simulation of equipment configurations, CPP strategies, and feeding profiles before execution. It can infer hard-to-measure state variables, assess scale equivalence, and support model-predictive and adaptive control by recommending near-optimal setpoints. By mapping high-dimensional parameter space and ranking limiting phenomena, AIS strengthens design-space definition, regulatory justification, first-time-right success, and manufacturing robustness.