Lyophilized vaccine development

The main goal in vaccine development is to ensure the delivery of an efficacious vaccine with an acceptable safety profile, which elicits the necessary immune response needed to protect from a natural infection. Vaccine antigens present a unique challenge to development scientists as they are often complex systems, and individual antigens may present stability challenges that are not well understood. Lyophilization may offer the benefit of stabilizing an antigen or a complex coformulation of several antigens, and perhaps even adjuvant, by immobilizing the antigen(s) in a glassy matrix. The process by which this occurs exposes the antigens to many stresses, which often can be circumvented through proper formulation and process optimizations. This chapter will review the general process and considerations for lyophilization, along with a review of types of antigens that have benefited from lyophilization. In addition, formulation and process considerations for these antigens will be discussed.