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Towards in silico Process Modeling for Vaccines.

Antonio Gaetano Cardillo1, Maria Monica Castellanos2, Benoit Desailly3

  • 1Technical Research and Development, GSK, 1 Via Fiorentina, 53100 Siena, SI, Italy.

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This summary is machine-generated.

Accelerating vaccine development requires in silico process development. This opinion focuses on a mechanistic approach, identifying key modeling competencies like fluid mechanics and thermodynamics as crucial for efficient vaccine manufacturing.

Keywords:
CMC accelerationin silico process developmentprocess modelingvaccines processing

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Engineering
  • Computational Modeling

Background:

  • Vaccine development timelines are significantly impacted by chemical, manufacturing, and control (CMC) processes.
  • Accelerating the end-to-end vaccine development lifecycle is a critical industry goal.

Purpose of the Study:

  • To explore the mechanistic approach to in silico process development for vaccines.
  • To identify essential modeling competencies required for this strategy.

Main Methods:

  • Analysis of common vaccine process units to determine modeling needs.
  • Identification of core scientific and data-driven competencies.

Main Results:

  • Key modeling competencies include fluid mechanics, thermodynamics, transport phenomena, intracellular modeling, hybrid modeling, data science, and model-based design of experiments.
  • These competencies are identified as pillars for vaccine process development.

Conclusions:

  • A mechanistic, in silico approach offers a viable strategy for accelerating vaccine development timelines.
  • A defined pathway exists for integrating these modeling competencies into a comprehensive in silico process development strategy.