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 through the combined use of synthesis workstations with integrated real time analytics providing 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. Tools such as in situ FTIR, FBRM®, or RTCal™, 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.
METTLER TOLEDO provides the enabling technology and software that helps chemists and engineers translate bench scale chemistry into a viable commercial process. For over 20 years our technology and services has provided a strategic resource that is used by thousands of scientists around the world to develop and deliver new chemical processes, or simply improve existing ones.