![]() ![]() ![]() The world watched with anticipation as researchers and manufacturers raced to develop cutting edge solutions to address an unprecedented global crisis. Furthermore, we review some of the challenges in implementing these technologies based on our expertise in process analytics for biopharmaceutical drug substance development.The COVID-19 pandemic has brought a surge of attention to the Life Sciences industry. Cyber-physical systems for data management, visualization, and repository must be established as part of Process Analytics 4.0 framework. Robotics and liquid handling workstations allow rapid assay and sample preparation automation to facilitate high-throughput testing of attributes and molecular properties which are otherwise challenging to monitor with PAT tools due to technological and business constraints. A systematic development and employment of PAT in process development workflows enable real time analytics for better process understanding, agility, and sustainability. Significant technological and business advantages can be gained with the implementation of digitalization, automation, and real time testing. This review is exclusively focused on dissecting high-level features of PAT, automation, and data management with some insights into the business aspects of implementing during process analytical testing in biologics process development. ![]() We introduce the term, Process Analytics 4.0 which entails not only technology aspects such as process analytical technology (PAT), assay automation, and high-throughput analytics, but also cyber-physical systems that enable data management, visualization, augmented reality, and internet of things (IoT) infrastructure for real time analytics in process development environment. Thus, the expansion of the process analytics tool box for rapid analytics with the deployment of cutting-edge technologies and cyber-physical systems is a necessity. Analytical testing of product quality attributes and process parameters during the biologics development (Process analytics) has been challenging due to the rapid growth of biomolecules with complex modalities to support unmet therapeutic needs. ![]()
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March 2023
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