Journal
TRENDS IN BIOTECHNOLOGY
Volume 38, Issue 10, Pages 1169-1186Publisher
CELL PRESS
DOI: 10.1016/j.tibtech.2020.07.004
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Funding
- College of Engineering at Purdue University
- College of Agriculture at Purdue University
- Purdue University Office of Agricultural Research and Graduate Education through its 150th Anniversary Elevating the Visibility of Agricultural Research
- Purdue College of Engineering Faculty Conversations (EFC)
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Process analytical technology (PAT) for the manufacture of monoclonal antibodies (mAbs) is defined by an integrated set of advanced and automated methods that analyze the compositions and biophysical properties of cell culture fluids, cell free product streams, and biotherapeutic molecules that are ultimately formulated into concentrated products. In-line or near-line probes and systems are remarkably well developed, although challenges remain in the determination of the absence of viral loads, detecting microbial or mycoplasma contamination, and applying data driven deep learning to process monitoring and soft sensors. In this review, we address the current status of PAT for both batch and continuous processing steps and discuss its potential impact on facilitating the continuous manufacture of biotherapeutics.
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