As an industry, we are uncovering ways to treat more complex targets, develop precision medicines, and advance transformative therapies. This evolving drug development landscape has resulted in the rapid advancement of molecules from development to the commercial stage. Accordingly, timelines for developing deep process understanding and performing essential activities prior to commercialization, such as process validation, have shortened.
The implementation of continuous manufacturing (CM) has been
shown to streamline development timelines and enable the rapid advancement of these therapies. Due to the relatively small scale nature of CM equipment, processes can be developed on commercial scale
equipment, reducing the need for and risks associated with scale-up and enabling relevant commercial manufacturing experience to be gained early in development. Additionally, advanced control
strategies based on continuous monitoring, high levels of automation, and additional levels of control are typically employed for routine CM. These advanced control strategies, coupled with the use
of commercial equipment for process development and clinical manufacture, result in high assurance that the proposed commercial process and control strategy will consistently manufacture high quality
products.
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