TY - JOUR
T1 - Toward in silico CMC
T2 - An industrial collaborative approach to model-based process development
AU - Roush, David
AU - Asthagiri, Dilip
AU - Babi, Deenesh K.
AU - Benner, Steve
AU - Bilodeau, Camille
AU - Carta, Giorgio
AU - Ernst, Philipp
AU - Fedesco, Mark
AU - Fitzgibbon, Sean
AU - Flamm, Matthew
AU - Griesbach, Jan
AU - Grosskopf, Tobias
AU - Hansen, Ernst B.
AU - Hahn, Tobias
AU - Hunt, Stephen
AU - Insaidoo, Francis
AU - Lenhoff, Abraham
AU - Lin, Jasper
AU - Marke, Henrik
AU - Marques, Bruno
AU - Papadakis, Emmanouil
AU - Schlegel, Fabrice
AU - Staby, Arne
AU - Stenvang, Marcel
AU - Sun, Larry
AU - Tessier, Peter M.
AU - Todd, Robert
AU - von Lieres, Eric
AU - Welsh, John
AU - Willson, Richard
AU - Wang, Gang
AU - Wucherpfennig, Thomas
AU - Zavalov, Oleksandr
N1 - Funding Information:
The authors would like to acknowledge Pablo Rolandi and Ben Smith (Amgen, Inc.) for their input and detailed reviews of the manuscript.
Publisher Copyright:
© 2020 Wiley Periodicals LLC
PY - 2020/12
Y1 - 2020/12
N2 - 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.
AB - 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.
KW - computational fluid dynamics
KW - mechanistic modeling
KW - molecular modeling
KW - plant simulation
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U2 - 10.1002/bit.27520
DO - 10.1002/bit.27520
M3 - Review article
C2 - 32725887
AN - SCOPUS:85089903870
SN - 0006-3592
VL - 117
SP - 3986
EP - 4000
JO - Biotechnology and Bioengineering
JF - Biotechnology and Bioengineering
IS - 12
ER -