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Current Pharmaceutical Biotechnology

Editor-in-Chief

ISSN (Print): 1389-2010
ISSN (Online): 1873-4316

Thermoanalytical Techniques for the Investigation of the Freeze Drying Process and Freeze-Dried Products

Author(s): Vicky Kett, Debra McMahon and Kevin Ward

Volume 6, Issue 3, 2005

Page: [239 - 250] Pages: 12

DOI: 10.2174/1389201054022850

Price: $65

Abstract

A key challenge facing the pharmaceutical industry is the production of biotechnological drug products such as proteins in a stable form. Freeze-drying is preferred for manufacturing such products because of the low temperatures used. However, the protein may still degrade during the process necessitating the inclusion of a protectant. This review describes the range of thermal analysis techniques that have been used to investigate the properties of formulations to be freeze dried and the resultant products. This approach has allowed insight into the key parameters required for design of formulations and processes that will generate the best possible products.

Keywords: dsc, freeze-drying, glass transition, microscopy, protectant, protein, lyophilisation

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