Conclusions
PAT is a useful paradigm and is making inroads into the biopharmaceutical industry, but the speed of acceptance has lagged
behind other industries, including typical pharmaceuticals. This delay in acceptance is unfortunate because PAT initiatives,
which are designed to develop a deeper understanding of the process and to control variability, could benefit biopharmaceuticals
more than any other industry because biological systems are so inherently variable. NIR and other analytical tools required
for this process understanding and variability control are already in place in other industries and will fit very well in
all stages of biopharmaceutical manufacture. FDA encourages the use of these tools in a well-designed PAT process, and their
use will reduce the time of manufacture and costs of reprocessed or out-of-specification product.
Todd Strother, PhD, is an applications scientist in the Scientific Instruments Division, Analyzer Group, at Thermo Fisher Scientific, 5225-4
Verona Road, Madison WI 53711, tel. 608.276.5626, todd.strother@thermofisher.com
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