(67c) Technology Advances That Will Enhance Continuous Biomanufacturing

The development of advanced biomanufacturing technologies involves consideration of converting batch manufacturing to continuous operation. Continuous manufacturing has a significant number of advantages that include operation of a manufacturing method that will produce consistent, high quality products at lower costs. This is achieved by using quality by design (QbD) principles which have been historically demonstrated to work in the continuous production of small molecules. It is done by reducing overall variability in the process which enables enhanced control within an optimized operating range. To implement this approach effectively for continuous biopharmaceutical processing, technology is needed in improved sampling, process analytical technology (PAT), and data handling. This will then allow for the determination of the critical quality attributes (CQA) and relate them to the critical process parameters (CPP) and show how these can be used to control process operation within the design space to enable real-time release testing (RTRT).