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
Current Pharmaceutical Biotechnology
Title: Thermoanalytical Techniques for the Investigation of the Freeze Drying Process and Freeze-Dried Products
Volume: 6 Issue: 3
Author(s): Vicky Kett, Debra McMahon and Kevin Ward
Affiliation:
Keywords: dsc, freeze-drying, glass transition, microscopy, protectant, protein, lyophilisation
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.
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Cite this article as:
Kett Vicky, McMahon Debra and Ward Kevin, Thermoanalytical Techniques for the Investigation of the Freeze Drying Process and Freeze-Dried Products, Current Pharmaceutical Biotechnology 2005; 6 (3) . https://dx.doi.org/10.2174/1389201054022850
DOI https://dx.doi.org/10.2174/1389201054022850 |
Print ISSN 1389-2010 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4316 |
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