Understand the basics of process analytical technology

Biotechnology and pharmaceutical companies can reap benefits from process analytical technology (PAT), which involves identifying critical process parameters (CPPs) that influence key product attributes and controlling these CPPs to improve process efficiency and product consistency. The FDA defines PAT as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPPs). PAT applications tend to be more complex for batch processes, as they often deal with time-varying, nonlinear, nonsteady-state semi-automated processes, instead of the more automated, steady-state processes characteristic of most continuous manufacturing processes. While significant levels of automation exist in some plants, many batch processes still typically include several manual operations. PAT has the potential to reduce the long cycle times and variability of many batch processes.