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

被引:27
|
作者
Roush, David [1 ]
Asthagiri, Dilip [2 ]
Babi, Deenesh K. [3 ]
Benner, Steve [1 ]
Bilodeau, Camille [4 ]
Carta, Giorgio [5 ]
Ernst, Philipp [6 ]
Fedesco, Mark [7 ]
Fitzgibbon, Sean [8 ]
Flamm, Matthew [1 ]
Griesbach, Jan [9 ]
Grosskopf, Tobias [10 ]
Hansen, Ernst B. [3 ]
Hahn, Tobias [11 ]
Hunt, Stephen [8 ]
Insaidoo, Francis [1 ]
Lenhoff, Abraham [12 ]
Lin, Jasper [7 ]
Marke, Henrik [3 ]
Marques, Bruno [13 ]
Papadakis, Emmanouil [3 ]
Schlegel, Fabrice [14 ]
Staby, Arne [3 ]
Stenvang, Marcel [3 ]
Sun, Larry [14 ]
Tessier, Peter M. [15 ]
Todd, Robert [8 ]
von Lieres, Eric [16 ]
Welsh, John [1 ]
Willson, Richard [17 ]
Wang, Gang [18 ]
Wucherpfennig, Thomas [18 ]
Zavalov, Oleksandr [1 ]
机构
[1] Merck & Co Inc, Kenilworth, NJ 07033 USA
[2] Rice Univ, Dept Chem & Biomol Engn, Houston, TX USA
[3] Novo Nordisk AS, Bagsvaerd, Denmark
[4] Rensselaer Polytech Inst, Dept Chem & Biol Engn, Troy, NY USA
[5] Univ Virginia, Dept Chem Engn, Charlottesville, VA USA
[6] Bayer AG, Leverkusen, Germany
[7] Genentech Inc, 460 Point San Bruno Blvd, San Francisco, CA 94080 USA
[8] KBI Biopharma, Boulder, CO USA
[9] F Hoffmann La Roche & Cie AG, Basel, Switzerland
[10] Roche Diagnost GmbH, Penzberg, Germany
[11] Karlsruhe Inst Technol, Karlsruhe, Germany
[12] Univ Delaware, Dept Chem & Biomol Engn, Newark, DE USA
[13] Century Therapeut, Philadelphia, PA USA
[14] Amgen Inc, Cambridge, MA USA
[15] Univ Michigan, Dept Chem Engn, Ann Arbor, MI 48109 USA
[16] Res Ctr Julich, Inst Bio & Geosci 1, Julich, Germany
[17] Univ Houston, Dept Chem & Biomol Engn, Houston, TX USA
[18] Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany
关键词
computational fluid dynamics; mechanistic modeling; molecular modeling; plant simulation; CHROMATOGRAPHY; SIMULATION;
D O I
10.1002/bit.27520
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
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.
引用
收藏
页码:3986 / 4000
页数:15
相关论文
共 50 条
  • [41] A model-based approach to improve planning practice in collaborative aerospace design
    Wynn, David
    Clarkson, P. John
    Eckert, Claudia
    Proceedings of the ASME International Design Engineering Technical Conferences and Computers and Information in Engineering Conference, Vol 5, 2005, : 537 - 548
  • [42] Tackling Model-Based Development Process and Organizational Challenges
    Zhu, Haifeng
    Wang, Grant
    2024 IEEE AEROSPACE CONFERENCE, 2024,
  • [43] Model-based development of an on-column PEGylation process
    Pfister, David
    Ingold, Oliver
    Morbidelli, Massimo
    REACTION CHEMISTRY & ENGINEERING, 2016, 1 (02): : 204 - 217
  • [44] Integrating Model-based Formal Timing Analysis in the Industrial Development Process of Satellite On-Board Software
    Henia, Rafik
    Rioux, Laurent
    Sordon, Nicolas
    Garcia, Gerald-Emmanuel
    Panunzio, Marco
    PROCEEDINGS OF THE 2014 2ND INTERNATIONAL CONFERENCE ON MODEL-DRIVEN ENGINEERING AND SOFTWARE DEVELOPMENT (MODELSWARD 2014), 2014, : 619 - 625
  • [45] In Silico Model-Based Inference: A Contemporary Approach for Hypothesis Testing in Network Biology
    Klinke, David J., II
    BIOTECHNOLOGY PROGRESS, 2014, 30 (06) : 1247 - 1261
  • [46] Model-based Process Planning for Milling Operations Using Industrial Robots
    Lienenlueke, Lars
    Gruendel, Lukas
    Storms, Simon
    Brecher, Christian
    2018 3RD INTERNATIONAL CONFERENCE ON CONTROL AND ROBOTICS ENGINEERING (ICCRE), 2018, : 37 - 44
  • [47] Longitudinal Model-Based Meta-Analysis in Rheumatoid Arthritis: An Application Toward Model-Based Drug Development
    Demin, I.
    Hamren, B.
    Luttringer, O.
    Pillai, G.
    Jung, T.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2012, 92 (03) : 352 - 359
  • [48] Model-based construction of collaborative systems
    Swaby, MA
    Dew, PM
    Kearney, PJ
    BT TECHNOLOGY JOURNAL, 1999, 17 (04) : 78 - 90
  • [49] Model-Based Collaborative Design in Engineering
    Tellioglu, Hilda
    COOPERATIVE DESIGN, VISUALIZATION, AND ENGINEERING, PROCEEDINGS, 2009, 5738 : 85 - 92
  • [50] Applying a model-based approach for embedded system development
    Bunse, Christian
    Gross, Hans-Gerhard
    Peper, Christian
    SEAA 2007: 33RD EUROMICRO CONFERENCE ON SOFTWARE ENGINEERING AND ADVANCED APPLICATIONS, PROCEEDINGS, 2007, : 121 - +