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Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications
Author(s) -
Read E.K.,
Park J.T.,
Shah R.B.,
Riley B.S.,
Brorson K.A.,
Rathore A.S.
Publication year - 2009
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.22528
Subject(s) - biopharmaceutical , process analytical technology , quality by design , quality (philosophy) , biochemical engineering , process (computing) , product (mathematics) , microbiology and biotechnology , computer science , quality assurance , upstream (networking) , manufacturing engineering , downstream processing , downstream (manufacturing) , engineering , process engineering , work in process , biology , operations management , mathematics , philosophy , geometry , external quality assessment , epistemology , operating system , computer network , biochemistry
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. Biotechnol. Bioeng. 2010; 105: 276–284. Published 2009 Wiley Periodicals, Inc.