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Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review
Author(s) -
Wasalathanthri Dhanuka P.,
Rehmann Matthew S.,
Song Yuanli,
Gu Yan,
Mi Luo,
Shao Chun,
Chemmalil Letha,
Lee Jongchan,
Ghose Sanchayita,
Borys Michael C.,
Ding Julia,
Li Zheng Jian
Publication year - 2020
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.27461
Subject(s) - biomanufacturing , process analytical technology , analytics , process (computing) , computer science , automation , data science , quality by design , visualization , quality (philosophy) , systems engineering , biopharmaceutical , engineering , manufacturing engineering , work in process , data mining , operations management , microbiology and biotechnology , biology , operating system , mechanical engineering , philosophy , epistemology , downstream (manufacturing)
Real‐time monitoring of bioprocesses by the integration of analytics at critical unit operations is one of the paramount necessities for quality by design manufacturing and real‐time release (RTR) of biopharmaceuticals. A well‐defined process analytical technology (PAT) roadmap enables the monitoring of critical process parameters and quality attributes at appropriate unit operations to develop an analytical paradigm that is capable of providing real‐time data. We believe a comprehensive PAT roadmap should entail not only integration of analytical tools into the bioprocess but also should address automated‐data piping, analysis, aggregation, visualization, and smart utility of data for advanced‐data analytics such as machine and deep learning for holistic process understanding. In this review, we discuss a broad spectrum of PAT technologies spanning from vibrational spectroscopy, multivariate data analysis, multiattribute chromatography, mass spectrometry, sensors, and automated‐sampling technologies. We also provide insights, based on our experience in clinical and commercial manufacturing, into data automation, data visualization, and smart utility of data for advanced‐analytics in PAT. This review is catered for a broad audience, including those new to the field to those well versed in applying these technologies. The article is also intended to give some insight into the strategies we have undertaken to implement PAT tools in biologics process development with the vision of realizing RTR testing in biomanufacturing and to meet regulatory expectations.