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Abstract
Freeze-drying is the preferred method for stabilizing live, attenuated virus vaccines.
After decades of research on several aspects of the process like the stabilization
and destabilization mechanisms of the live, attenuated viruses during freeze-drying,
the optimal formulation components and process settings are still matter of research.
The molecular complexity of live, attenuated viruses, the multiple destabilization
pathways and the lack of analytical techniques allowing the measurement of physicochemical
changes in the antigen's structure during and after freeze-drying mean that they form
a particular lyophilization challenge. The purpose of this review is to overview the
available information on the development of the freeze-drying process of live, attenuated
virus vaccines, herewith focusing on the freezing and drying stresses the viruses
can undergo during processing as well as on the mechanisms and strategies (formulation
and process) that are used to stabilize them during freeze-drying.