CC-Sim: Abstract

Intro

Biopharmaceuticals are notoriously expensive to bring to market, costing >$1b and having a 90%+ failure rate. One significant factor in this is the cost of process development; while process science knowledge is growing significantly every year, hundreds of capital, labor, and resource-intensive experiments must be run to optimize and characterize every process individually. A robust platform allows for process development costs to be reduced, but is itself also time and resource intensive to develop.

Abstract

CC-Sim (CellCulture-Simulator) is a system-level simulation that models the cell culture process, combining a cell model, control strategies, bioreactors, actuation devices, assays, and media definitions in order to simulate the defined platform. The entirely digital nature of CC-Sim allows for automated and mass-testing of described experiments at greatly reduced costs to highlight potential problems and allow screening of solutions, all without having to run a physical experiment.