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Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications
Author(s) -
Read E.K.,
Shah R.B.,
Riley B.S.,
Park J.T.,
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.22529
Subject(s) - quality by design , process analytical technology , quality (philosophy) , biochemical engineering , biopharmaceutical , process (computing) , computer science , product (mathematics) , manufacturing engineering , downstream (manufacturing) , chemometrics , pharmaceutical manufacturing , process engineering , systems engineering , microbiology and biotechnology , engineering , work in process , mathematics , operations management , biology , bioinformatics , philosophy , geometry , epistemology , machine learning , operating system
Implementing real‐time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: “variability is managed by the process” and “product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions.” The first part of the paper presented an overview of PAT concepts and applications in the areas of upstream and downstream processing. In this second part, we present principles and case studies to illustrate implementation of PAT for drug product manufacturing, rapid microbiology, and chemometrics. We further present our thoughts on how PAT will be applied to biotech processes going forward. The role of PAT as an enabling component of the Quality by Design framework is highlighted. Integration of PAT with the principles stated in the ICH Q8, Q9, and Q10 guidance documents is also discussed. Biotechnol. Bioeng. 2010; 105: 285–295. Published 2009 Wiley Periodicals, Inc.