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Mechanistic Modeling of Continuous Lyophilization for Biopharmaceutical Manufacturing.

Prakitr Srisuma1, Gang Chen1, Richard D Braatz1

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This study introduces the first mechanistic model for continuous lyophilization (freeze drying), crucial for pharmaceutical manufacturing and mRNA vaccines. The model accurately predicts key parameters, enabling process optimization and guiding future development.

Keywords:
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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Modeling

Background:

  • Lyophilization (freeze drying) enhances drug product stability, with recent use in mRNA vaccines.
  • Current industrial lyophilization predominantly uses batch processing, despite a shift towards continuous manufacturing.
  • There is a need for advanced models to support continuous lyophilization development.

Purpose of the Study:

  • To present the first mechanistic model for a complete continuous lyophilization process.
  • To incorporate and describe key transport phenomena across all lyophilization stages (freezing, primary drying, secondary drying).
  • To provide a tool for model-based design and optimization of continuous lyophilization.

Main Methods:

  • Development of a mechanistic model for continuous lyophilization.
  • Incorporation of transport phenomena in freezing, primary drying, and secondary drying stages.
  • Modeling of state-of-the-art continuous lyophilization technology with suspended, moving vials.

Main Results:

  • The validated model accurately predicts critical process parameters: product temperature, ice/water fraction, sublimation front position, and bound water concentration.
  • Demonstration of model applications in continuous lyophilization process design and optimization.
  • The model is released as an open-source software package.

Conclusions:

  • The developed mechanistic model is a significant advancement for continuous lyophilization.
  • The model can guide the design and development of future continuous lyophilization processes.
  • Availability as open-source software promotes wider adoption and innovation in pharmaceutical manufacturing.