CHRISTINA CAPORALE1*, TERÉSE JOSEPH1, JULIO HUATO HERNANDEZ1, JULIA SAWAYA1, LIAM DELANEY1, KEITH GILLETTE2, MARK SCHOFIELD1, KURT BOENNING1
*Corresponding author
1. Cytiva, Westborough, MA, United States
2. Sartorius Stedim North America, Bohemia, NY, United States

Abstract

Process intensification of biomanufacturing offers the promise of improved control and consistency along with more efficient production. Within the available process intensification scenarios, integrated continuous bioprocessing is an innovative approach facilitated through fully automated end-to-end platforms. A standardized approach to these platforms for the purification of monoclonal antibodies has been considered. However, the control of these platforms is not well understood, characterized, nor discussed. Here we discuss an easily scalable universal valving and pump control solution to facilitate such processes.

Introduction
Improved patient access through cost reduction is motivating the implementation of process intensification. Beyond pure cost incentives, the desire for real-time drug release (1-3), improved product quality (2, 3), minimized waste and facility footprint (4, 5), increased manufacturing flexibility (5), and decreased environmental impact (6) drive the industry to adopt automated continuous processing (7).

Legacy mAb processes have been facilitated predominately through fed-batch bioreactor operations coupled with batch purification unit operations. In recent years, key integrated continuous bioprocessing (ICB) enabling technologies such as perfusion cell culture, multi column chromatography (MCC), and single-pass tangential flow filtration (SPTFF) have driven the industry towards more modern manufacturing capabilities. The earliest published ICB implementation with CHO cell perfusion cell culture was demonstrated with four column periodic counter-current chromatography (PCC) for continuous capture (8).

In the subsequent decade, a variety of end-to-end lab scale processes have been accomplished with some pi ...