Characterization of Formulations for Freeze-Drying

  • Kevin R. WardEmail author
  • Paul Matejtschuk
Part of the Methods in Pharmacology and Toxicology book series (MIPT)


One of the most wide-reaching changes in freeze-drying over the past 20 years has been the commercial availability of a range of discriminating analytical methods to identify critical temperatures in formulations to be freeze dried. Here, we briefly describe the development of these techniques from the earlier bespoke methods, setting their rise in a historical context. We then review techniques such as freeze-drying microscopy, differential scanning calorimetry, and less widely applied alternative technologies. Practical examples of the results obtained with these techniques are discussed and upcoming new trends and troubleshooting problems are addressed.

Key words

Freeze-drying microscopy Differential scanning calorimetry Dynamic mechanical analysis Thermal analysis Impedance TASC Optical coherence tomography 



We thank Kiran Malik and Chinwe Duru (NIBSC) for performing many of the thermal analyses included in the figures, Thomas Codd (BPS) for compiling many of the FDM and TASC images, and Jason Hockley (Biostatistician at NIBSC) for statistical analysis of the raw data from the TASC subjectivity study.


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Biopharma Process Systems LtdWinchesterUK
  2. 2.National Institute for Biological Standards & Control (NIBSC)Potters BarUK

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