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Accelerating vaccine manufacturing development through model-based approaches: current advances and future opportunities

Peer reviewed scientific article

Anglais

SCIENSANO

Auteurs

Elham Ramin [1]; Antonio Gaetano Cardillo [2]; Reinhard Liebers [3]; Johannes Schmölder [4]; Eric von Lieres [5]; Wim Van Molle [6]; Bastian Niebel [7]; Laurent Natalis [8]; Irina Meln [9]; Mónica Perea-Vélez [10]; Didier Clénet [11]; John Bagterp Jørgensen [12]; Bernt Nilsson [13]; Daniel G. Bracewell [14]; Krist V. Gernaey [15]

Mots-clés

    Résumé:

    This review highlights the importance of model-based approaches in accelerating vaccine manufacturing process development. The challenges of scaling up from laboratory to commercial processes are addressed through the adoption of Process Analytical Technology frameworks and Quality by Design principles. The application of various modeling approaches beyond downstream and upstream processes in vaccine production is discussed in detail. These in silico process simulation approaches enable deeper understanding of manufacturing dynamics, identification of critical p…
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    Résumé

    This review highlights the importance of model-based approaches in accelerating vaccine manufacturing process
    development. The challenges of scaling up from laboratory to commercial processes are addressed through the adoption of
    Process Analytical Technology frameworks and Quality by Design principles. The application of various modeling
    approaches beyond downstream and upstream processes in vaccine production is discussed in detail. These in silico
    process simulation approaches enable deeper understanding of manufacturing dynamics, identification of critical process
    parameters, and the development of well-defined design spaces, ultimately leading to accelerated vaccine development
    and improved product quality. The authors stress the significance of an integrated modeling platform for vaccine
    manufacturing, exemplified by the Inno4Vac project. This initiative seeks to develop a comprehensive computational
    platform for vaccine manufacturing and stability testing, with a particular focus on stakeholder engagement and collaboration
    with regulatory bodies to ensure the acceptance and implementation of the platform.

    Associated health topics:


    Source URL:https://www.sciensano.be/fr/biblio/accelerating-vaccine-manufacturing-development-through-model-based-approaches-current-advances-and

    Liens
    [1] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187188&f%5Bsearch%5D=Elham%20Ramin [2] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187189&f%5Bsearch%5D=Antonio%20Gaetano%20Cardillo [3] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187190&f%5Bsearch%5D=Reinhard%20Liebers [4] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187191&f%5Bsearch%5D=Johannes%20Schm%C3%B6lder [5] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187192&f%5Bsearch%5D=Eric%20von%20Lieres [6] https://www.sciensano.be/fr/people/wim-van-molle/biblio [7] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187193&f%5Bsearch%5D=Bastian%20Niebel [8] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187194&f%5Bsearch%5D=Laurent%20Natalis [9] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187195&f%5Bsearch%5D=Irina%20Meln [10] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187196&f%5Bsearch%5D=M%C3%B3nica%20Perea-V%C3%A9lez [11] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187197&f%5Bsearch%5D=Didier%20Cl%C3%A9net [12] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187198&f%5Bsearch%5D=John%20Bagterp%20J%C3%B8rgensen [13] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187199&f%5Bsearch%5D=Bernt%20Nilsson [14] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187200&f%5Bsearch%5D=Daniel%20G.%20Bracewell [15] https://www.sciensano.be/fr/biblio?f%5Bauthor%5D=187201&f%5Bsearch%5D=Krist%20V.%20Gernaey