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Microglassification™: a novel technique for protein dehydration.

Aniket1, David A Gaul, Deborah L Rickard

  • 1Department of Mechanical Engineering and Materials Science, Duke University, Durham, North Carolina.

Journal of Pharmaceutical Sciences
|January 14, 2014
PubMed
Summary

Microglassification™ rapidly dehydrates protein solutions into stable amorphous microspheres at room temperature. This novel process preserves protein structure and function upon rehydration, offering a new method for biologic preservation.

Keywords:
dehydrationmicroparticlesprocessingprotein formulationprotein structure

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Area of Science:

  • Biotechnology
  • Materials Science
  • Pharmaceutical Sciences

Background:

  • Dehydration of biologics is crucial for solid-dose formulation and long-term stability.
  • Current methods may impact protein structure and function.

Purpose of the Study:

  • To introduce and validate a novel dehydration process, Microglassification™, for protein solutions.
  • To assess the impact of Microglassification™ on protein structure, concentration, and rehydration capabilities.

Main Methods:

  • Microglassification™ process applied to bovine serum albumin (BSA) microdroplets and bulk solutions.
  • Real-time observation of droplet dissolution and correlation with water activity.
  • Analysis of BSA secondary structure and aggregation using spectroscopy and gel electrophoresis.

Main Results:

  • Formation of solid amorphous BSA microspheres with high protein concentration (up to 1147 ± 32 mg/mL).
  • Successful dehydration to levels below monolayer water coverage.
  • Reverted to native-like conformation upon rehydration with minimal irreversible aggregation (2.7%).

Conclusions:

  • Microglassification™ is an effective and controllable method for dehydrating biologics.
  • The process yields stable amorphous microspheres while preserving protein integrity.
  • This technique holds promise for improved biologic formulation and preservation.