Gary opens noting how these manufacturers are challenged to respond to new methods for drug process development and manufacturing. The U.S. Food and Drug Administration (FDA) is driving manufacturers in the Life Sciences industries to base their development efforts on science, process understanding and a risk-based approach.
In response, these manufacturers are embracing new methods such as Quality by Design (QbD), process analytical technology (PAT) and continuous process verification (CPV). Under these methods, manufacturers no longer validate processes by proving quality is repeatable. Instead, they must understand the relationships between critical process parameters (CPPs) and their impacts on critical quality attributes (CQAs).
And, they must understand how these CQAs affect drug efficacy and patient safety. Manufacturers using PAT and CPV continuously monitor their process to detect any undesired variability in order to identify and anticipate problems to be able to take immediate corrective action.
Gary explains that while this shift delivers benefits, it also introduces a set of challenges. The first challenge is to collect and analyze the data to determine the relationships between the critical process parameters and the critical quality attributes. This requires precise, accurate and reliable measurements and capable software for collection and analysis.
The next challenge is to measure CQAs in real time, which often require advanced analytical instruments such as near infrared spectroscopy (NIRS) analyzers. Labs have used these instruments for many years, but having them operate continuously in real time is a recent challenge.
Gary describes another challenge of integrating process and quality data into multivariate models that execute in real time and are integrated into the control strategies to keep the processes on track.
At the 2:30 mark in the video, Gary shows some of the technologies that help address these challenges such as Rosemount and Micro Motion measurement devices, a DeltaV distributed control system and embedded batch analytics, process modeling software, Syncade Suite operations management software and SynTQ PAT process data software.
Gary and the Life Sciences consulting team work with pharmaceutical and biotech manufacturers to develop solutions based upon these technologies to help manage quality in real time using PAT and CPV methods.
You can connect and interact with other Life Science professionals in the Life Sciences track of the Emerson Exchange 365 community.