Below is a recap of the Facility of the Future shared at ISPE Annual Meeting 2018.
Manufacturing of biologics, whether vaccines, hormones, or proteins is a complex process. Both upstream and downstream processes are subject to sensitive parameter changes such as variations in raw materials, equipment settings, and environmental conditions that can impact product quality, yield, and manufacturing reproducibility. These challenges, if not addressed appropriately, can cost organizations significantly. The possible impacts include product delays, regulatory compliance challenges, and ultimately lost revenue.
FDA guidelines state that quality is to be built into manufacturing processes. Additionally, the FDA is encouraging new manufacturing technologies through the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base guidance. This guidance welcomes collaboration with the FDA for the introduction of solutions that collect, process, and analyze large data streams. New technologies, such as Internet of Things (IoT) and cloud storage are key to implementing big data solutions for biologics manufacturing.
The Elemental Machines solution includes Elements, IoT-equipped devices, that can be placed in laboratories, production floors, and on scientific instruments for continuous data collection of equipment settings, equipment outputs, and ambient environmental parameters. The information is aggregated onto the Elemental Machines Insights Dashboard for further analysis to evaluate and trend manufacturing outcomes in real-time. The continuous data measurements allow teams to gain a deeper understanding of manufacturing quality through comprehensive data analytics solutions.
The FDA surmises that improved quality can be achieved through comprehensive data-driven solutions. The Elemental Machines data platform offers biologics manufacturers a comprehensive tool for driving quality improvement.
Accelerate your time-to-market with Elemental Machines’ Connected Operations platform for pharmaceutical engineering.