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

David Roush, Dilip Asthagiri, Deenesh K. Babi, Steve Benner, Camille Bilodeau, Giorgio Carta, Philipp Ernst, Mark Fedesco, Sean Fitzgibbon, Matthew Flamm, Jan Griesbach, Tobias Grosskopf, Ernst B. Hansen, Tobias Hahn, Stephen Hunt, Francis Insaidoo, Abraham Lenhoff, Jasper Lin, Henrik Marke, Bruno MarquesEmmanouil Papadakis, Fabrice Schlegel, Arne Staby, Marcel Stenvang, Larry Sun, Peter M. Tessier, Robert Todd, Eric von Lieres, John Welsh, Richard Willson, Gang Wang, Thomas Wucherpfennig, Oleksandr Zavalov

Research output: Contribution to journalReview articlepeer-review

31 Scopus citations

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.

Original languageEnglish
Pages (from-to)3986-4000
Number of pages15
JournalBiotechnology and Bioengineering
Volume117
Issue number12
DOIs
StatePublished - Dec 2020
Externally publishedYes

Funding

The authors would like to acknowledge Pablo Rolandi and Ben Smith (Amgen, Inc.) for their input and detailed reviews of the manuscript.

FundersFunder number
Pablo Rolandi and Ben Smith (Amgen, Inc.

    Keywords

    • computational fluid dynamics
    • mechanistic modeling
    • molecular modeling
    • plant simulation

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