Today’s researchers are under increasing pressure to bring new products to market faster, at lower costs and with higher quality. The design and delivery of a safe, sustainable and robust process which can be used at production scale is a critical step in bringing a new product to market.
Designing a chemical process involves building a comprehensive knowledge and understanding of the chemical reactions being used, as well as the associated critical process parameters.
During early phase development, researchers must be quickly but safely provide a few kilograms of material, while working to establish cost effective synthetic routes. This can be achieved with the use of synthesis workstations with integrated analytics during early phase development. The same researchers must also quickly evaluate the merits of a batch, semi-batch or continuous approach to manufacturing the product at scale.
As the process is continually developed, quality process knowledge is gained with chemical, particle, thermodynamic and kinetic related information. Understanding the thermodynamics of a chemical process is key to assessing the hazardous potential of a chemical process and directly linked to the energy of a reaction and the accumulation of reagents. Therefore, process safety studies are crucial and an integral part of the development of environmentally friendly processes.
When the process is moved from lab to plant, Process Analytical Technology (PAT) is used to ensure the process is within the required boundaries as the scale increases.
As companies seek to realize the benefits from the Quality by Design (QbD) approach, Process Analytical Technology (PAT) is being implemented throughout the chemical and biopharmaceutical industries at an increasing rate. PAT tools support the design of safe and robust procedures that build quality into the commercial process. This allows the delivery of processes that ensure higher yields with higher quality at lower costs, while delivering improved cycle times and reducing batch failures.