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Process analytical technology (PAT) has been gaining momentum in the biotech community due to the potential for continuous real-time quality assurance resulting in improved operational control and compliance. In this two part series, we address PAT as it applies to processes that produce biotech therapeutic products. In the first part, we address evolution of the underlying concepts and applications in biopharmaceutical manufacturing. We also present a literature review of applications in the areas of upstream and downstream processing to illustrate how implementation of PAT can help realize advanced approaches to ensuring product quality in real time. In the second part, we will explore similar applications in the areas of drug product manufacturing, rapid microbiology, and chemometrics as well as evolution of PAT in biotech processing.
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
September 2010,
Analytical and bioanalytical chemistry,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
January 2013,
Applied biochemistry and biotechnology,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
April 2011,
Biotechnology journal,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
December 2022,
Current opinion in biotechnology,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
January 2016,
Biotechnology progress,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
November 2018,
Chimia,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
January 2009,
Pharmaceutical development and technology,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
February 2008,
Journal of pharmaceutical sciences,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
July 2014,
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V,
E K Read, and
J T Park, and
R B Shah, and
B S Riley, and
K A Brorson, and
A S Rathore
January 2023,
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica,
