Development and manufacturing of therapeutics, whether pharmaceuticals, vaccines, hormones, or proteins is a complex process. Both R&D and manufacturing 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 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 is encouraging the use of new technologies through initiatives such as the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base guidance.  The goal is to introduce solutions that can accelerate collection, processing, and analysis of large data streams.   New technologies, such as Internet of Things (IoT) and cloud technology are key to implementing big data solutions for life sciences R&D and manufacturing.

The Elemental Machines solution includes Elements, IoT-equipped devices, that can be placed in R&D 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 cloud-based Elemental Machines Insights Dashboard for further analysis to evaluate and trend research and manufacturing outcomes in real-time. The continuous data measurements allow teams to gain a deeper understanding of process outcomes 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 life sciences companies a comprehensive tool for accelerating science and driving overall quality improvement.

Accelerate your time-to-market with Elemental Machines’ connected platform!