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Review
. 2021 Nov;39(11):1120-1130.
doi: 10.1016/j.tibtech.2021.02.004. Epub 2021 Mar 8.

Towards in silico Process Modeling for Vaccines

Antonio Gaetano Cardillo  1 , Maria Monica Castellanos  2 , Benoit Desailly  3 , Sandrine Dessoy  3 , Marco Mariti  1 , Rui M C Portela  3 , Bernadette Scutella  2 , Moritz von Stosch  4 , Emanuele Tomba  1 , Christos Varsakelis  5
Affiliations
Review

Towards in silico Process Modeling for Vaccines

Antonio Gaetano Cardillo et al. Trends Biotechnol. 2021 Nov.

Abstract

Chemical, manufacturing, and control development timelines occupy a significant part of vaccine end-to-end development. In the on-going race for accelerating timelines, in silico process development constitutes a viable strategy that can be achieved through an artificial intelligence (AI)-driven or a mechanistically oriented approach. In this opinion, we focus on the mechanistic option and report on the modeling competencies required to achieve it. By inspecting the most frequent vaccine process units, we identify fluid mechanics, thermodynamics and transport phenomena, intracellular modeling, hybrid modeling and data science, and model-based design of experiments as the pillars for vaccine development. In addition, we craft a generic pathway for accommodating the modeling competencies into an in silico process development strategy.

Keywords: CMC acceleration; in silico process development; process modeling; vaccines processing.

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Conflict of interest statement

Declaration of Interests The authors declare the following interest: All authors are employees of the GSK group of companies with the exception of M.v.S. who was a GSK employee during the drafting of the manuscript and is now an employee of DataHow AG, and C.V. who was an employee of GSK during the drafting, submission, and revision of the manuscript, and is now an employee of the Janssen Pharmaceutical Companies. S.D. reports ownership of GSK shares and/or restricted GSK shares.

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