(763g) Design of Integrated Monoclonal Antibody Production: Opportunities for Continuous Manufacturing
Pilot-scale production data has been obtained from a research facility for the production of mAbs from Chinese Hamster Ovary (CHO) cells. Models for different upstream and downstream units have been developed and fitted against the available data for validation. The developed models were used to compare the effect of different operating modes for the cultivation units: batch, fed-batch, and perfusion; and for the chromatography units: batch vs. continuous operation through simulated moving bed (SMB), or multi-column periodic counter-current chromatography (PCC). An economic assessment was conducted to compare the results of the generated scenarios. A complementary performance analysis in terms of productivity enhancement was also conducted.
A sensitivity analysis was further carried out and the results show a strong dependence of the process performance and favorable operating modes on the required production size and scale as well as other cell performance parameters. Recent developments in cell performance and tolerance is shown to be a strong factor affecting preferential process operation modes. The results of this analysis can be used to set guidelines for further cell development efforts. The interdependence of the process performance on the different aspects of cell design and product properties highlights the need for the integrated and simultaneous design of cell, product, and process parameters.