Design Of Experiment-Based Virus Like Particle Vaccine Formulation Development

In this study, we developed a strategy using the design of experiment (DoE) technique for the initial formulation development of a virus-like particle (VLP) vaccine protein. We selected the buffer type through a single-variable experiment and determined the buffer concentration, pH, and salt concentration through two rounds of DoE screening. We established the formulation conditions by analyzing the physical properties of each test condition under harsh storage. To improve the VLP protein stability, we tested additives in a third DoE screening round and the final formulation condition defined via three DoE rounds was 20 mM Tris buffer (pH 8.1). The late vaccine development stage necessitates formulation process optimization. DoE assessments using such a full factorial design or response surface model design could be conducted to determine the design space for each process parameter.