Lyophilization of Adjuvanted Vaccines: Methods for Formulation of a Thermostable Freeze-Dried Product.

Abstract

Lyophilization of vaccines is advantageous for the distribution and storage of thermally labile products, particularly in regions where cold chain management is difficult. To date, current lyophilized vaccines do not contain an adjuvant. Instead, adjuvanted vaccines may be presented as a two vial system, that require bedside-mixing prior to immunization. Here we present an example of a lyophilization cycle that we have used to successfully freeze-dry an adjuvanted protein formulation in a single vial.