(696d) Optimization and Scaleup of an Intensified Upstream Process

Intensified fed-batch processes have the potential to both reduce production bioreactor duration and increase product titer. These processes are characterized by high seeding densities, typically greater than 5 million cells per milliliter. The high seed densities are achieved by implementing perfusion in the N-1 step. The use of perfusion and higher peak cell densities in the production bioreactor introduce operational and scaleup complexity through introduction of new variables and high oxygen requirements. We will highlight our work in optimizing N-1 and N unit operations to ensure the process is robust and scalable. We demonstrated the successful execution of this intensified upstream process with comparable performance across both bench scale and pilot scale operations.