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Review
. 2020 Dec;117(12):3986-4000.
doi: 10.1002/bit.27520. Epub 2020 Aug 29.

Toward in silico CMC: An industrial collaborative approach to model-based process development

David Roush  1 , Dilip Asthagiri  2 , Deenesh K Babi  3 , Steve Benner  1 , Camille Bilodeau  4 , Giorgio Carta  5 , Philipp Ernst  6 , Mark Fedesco  7 , Sean Fitzgibbon  8 , Matthew Flamm  1 , Jan Griesbach  9 , Tobias Grosskopf  10 , Ernst B Hansen  3 , Tobias Hahn  11 , Stephen Hunt  8 , Francis Insaidoo  1 , Abraham Lenhoff  12 , Jasper Lin  7 , Henrik Marke  3 , Bruno Marques  13 , Emmanouil Papadakis  3 , Fabrice Schlegel  14 , Arne Staby  3 , Marcel Stenvang  3 , Larry Sun  14 , Peter M Tessier  15 , Robert Todd  8 , Eric von Lieres  16 , John Welsh  1 , Richard Willson  17 , Gang Wang  18 , Thomas Wucherpfennig  18 , Oleksandr Zavalov  1
Affiliations
Review

Toward in silico CMC: An industrial collaborative approach to model-based process development

David Roush et al. Biotechnol Bioeng. 2020 Dec.

Abstract

The Third Modeling Workshop focusing on bioprocess modeling was held in Kenilworth, NJ in May 2019. A summary of these Workshop proceedings is captured in this manuscript. Modeling is an active area of research within the biotechnology community, and there is a critical need to assess the current state and opportunities for continued investment to realize the full potential of models, including resource and time savings. Beyond individual presentations and topics of novel interest, a substantial portion of the Workshop was devoted toward group discussions of current states and future directions in modeling fields. All scales of modeling, from biophysical models at the molecular level and up through large scale facility and plant modeling, were considered in these discussions and are summarized in the manuscript. Model life cycle management from model development to implementation and sustainment are also considered for different stages of clinical development and commercial production. The manuscript provides a comprehensive overview of bioprocess modeling while suggesting an ideal future state with standardized approaches aligned across the industry.

Keywords: computational fluid dynamics; mechanistic modeling; molecular modeling; plant simulation.

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References

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