Biomedical Engineering Reference
In-Depth Information
12
PAT TOOLS FOR BIOLOGICS:
CONSIDERATIONS AND
CHALLENGES
Michael Molony and Cenk Undey
12.1 INTRODUCTION
Process analytical technology (PAT) is the latest name given to a long-standing
practice of engineers and scientists applying analytical tools to manufacturing
processes to obtain new information, not gained from conventional analyses. Unlike
other biologics industry-specific disciplines, this practice crosses the boundaries of
many different types of manufacturing processes with the simple goal of increasing
process understanding to the point of allowing some level of control. The desired
output is to decrease the variability of the process resulting in a more consistent
process with more predictable product quality. Several tool sets are at the disposal of
the process analytical chemist and engineer. These include traditional laboratory
analytical techniques applied online or in-line, automated laboratory control systems
and software, multivariate data analysis techniques, and an array of next-generation
analytical instrumentation and equipment specifically designed for process monitor-
ing and control.
In biologics manufacturing, much of the current work involving in-line analytics
emanates from the spectroscopic array, including Mid-IR, NIR, UV, fluorescence,
Raman, and FTIR as well as the more commonly used simple control of pH, temperature,
