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A NIR-Based Study of Desorption Kinetics during Continuous Spin Freeze-Drying.

Laurens Leys1, Gust Nuytten1, Joris Lammens2

  • 1Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, 9000 Ghent, Belgium.

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|December 28, 2021
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Summary

Continuous spin freeze-drying significantly reduces biopharmaceutical drying times. Near-infrared spectroscopy effectively monitors residual moisture, optimizing process parameters like product temperature and cooling rate for faster desorption kinetics.

Keywords:
continuous freeze-dryingcontinuous manufacturingdesorptionfreeze-dryingnear-infraredsecondary drying

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Analytical Technology (PAT)
  • Drying Technologies

Background:

  • The pharmaceutical industry is shifting towards continuous manufacturing and enhanced process understanding.
  • Process Analytical Technology (PAT) tools are crucial for implementing improved process control.
  • Conventional batch freeze-drying is time-consuming for biopharmaceuticals.

Purpose of the Study:

  • To develop and apply a near-infrared (NIR) spectroscopy methodology for studying desorption kinetics in continuous spin freeze-drying.
  • To construct and validate an inline NIR calibration model for predicting residual moisture content.
  • To evaluate the impact of various process parameters on the desorption rate during secondary drying.

Main Methods:

  • Development of a continuous spin freeze-drying technology utilizing thin product layers, vacuum, and infrared heating.
  • Implementation of inline near-infrared (NIR) spectroscopy with a Partial Least Squares (PLS) model for real-time moisture monitoring.
  • Validation of the NIR model using a standard 10% sucrose formulation.

Main Results:

  • The continuous spin freeze-drying process reduced drying times by over 90% compared to conventional methods.
  • The developed NIR model accurately predicted residual moisture content.
  • Product temperature (PID-controlled IR heaters) showed the most significant positive impact on the secondary drying rate.
  • Higher cooling rates during spin freezing also increased desorption rates.
  • Filling volume had a minor negative effect, while chamber pressure (10-30 Pa) had no significant effect on drying rate.

Conclusions:

  • Inline NIR spectroscopy is a viable tool for monitoring desorption kinetics in continuous spin freeze-drying.
  • Optimizing product temperature and cooling rate are key to enhancing the efficiency of the secondary drying step.
  • Continuous spin freeze-drying offers a substantial advancement in biopharmaceutical drying technology.