Abstract
Legacy batch processing carried out in pharmaceutical and biopharmaceutical sectors is undergoing transformation to adopt the next generation continuous processing to produce safe and effective drugs with better efficiency and consistency at a reduced cost. To facilitate innovative continuous processing, enabled by an end-to-end process with a single uninterrupted production scenario, it is essential to generate real-time or near-real-time data using process analytical technology (PAT), which has been defined by the FDA as a system for designing, analyzing, and controlling manufacturing through timely measurements to ensure final product quality. Based on quality by design (QbD) principles, PAT-enabled data monitoring is essential for the timely control of critical process parameters (CPPs) and critical quality attributes (CQAs) to keep the process in a desired state of control to achieve a predefined product quality. Based on QbD philosophy, quality cannot be tested into products; it should be built-in or should be by design. Deployment of PAT tools for real-time monitoring is integral to align with the guiding principles of QbD-enabled workflow to enhance process and product understanding to administer a control strategy to keep the process within the design space. Aim of this chapter is to highlight the recent advancements in PAT tool-development to monitor and control CPPs and CQAs.
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