Scientific and Regulatory Overview of Process Analytical Technology in Bioprocesses
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Process analytical technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes based on (1) an understanding of the scientific and engineering principles involved and (2) identification of variables that affect product quality. In the pharmaceutical world, PAT concepts were adopted early on by the small molecule industry; the progress in biotech community may be more incremental and gradual but optimistic. The PAT approach should give the biotech industry an incentive to explore various preexisting or novel analytical tools for measurements during, rather than at the end of, a process to get more information about the process and control it in real time. With biopharmaceuticals, testing is more complex; one cannot test for everything. However, we believe that the targeted research and development (R&D) can make PAT approaches evolve even for complex protein properties such as secondary structure and glycosylation patterns. We envision that PAT evolves from process control based on real-time measurement of (1) parameters that confirm that a unit operation/piece of equipment continues to be fit for purpose, moving on to (2) those parameters that directly correlate with critical quality
