Pharmaceutical Technology-03-01-2004

The author covers the fundamentals of lyophilization and provides case studies about the development of lyophilized biopharmaceutical products and the importance of biophysical characterization in formulaiton and the lyophilization process.

Electrical resistance, low temperature scanning calorimetry, and freeze-drying microscopy are three analytical methods that can be used to determine the thermal characterization of a product during processing for intended development of a lyophilization cycle.

Though recognized by the public since freeze-dried coffee hit the market 30 years ago, lyophilization remains far from mature and deserves more research.