DigiGlyc: A hybrid tool for reactive scheduling in cell culture systems

Chinese hamster ovary (CHO) cell culture systems are the most widely used platform for the industrial production of monoclonal antibodies (mAbs). The optimisation of manufacturing conditions for these high-value products is largely conducted off-line with little or no monitoring of mAb quality in-process. Here, we propose DigiGlyc, a hybrid model of these systems that predicts the critical quality attribute of mAb galactosylation. Having shown that DigiGlyc describes a wide range of experimental data well, we demonstrate that it can be used for the design of reactive optimisation studies. This hybrid formulation offers considerable gains in computational speed compared to mechanistic models with no loss in fidelity and can therefore underpin future online control and optimisation studies. (c) 2021 Elsevier Ltd. All rights reserved.

Automated summary

CHO cell culture systems are widely used for industrial production of mAbs, but there is currently limited monitoring of mAb quality in-process. The DigiGlyc model predicts the critical quality attribute of mAb galactosylation and can be used for reactive optimization studies, offering computational speed gains without loss of fidelity.