Enhanced Stability of Inactivated Foot-And-Mouth Disease Virus Vaccine With A Novel Solution Buffer.

Objectives: Stability is vital for potency of food-and-mouth disease virus vaccine preparation. However, the assembly of inactivated foot-and-mouth disease virus is poor stable and prone to dissociate into 12s under mild acidic or heating conditions, especially emulsified with oil-adjuvant. Thus, it is crucial to explore a suitable medium and condition to improve the stability and efficiency of inactivated FMDV vaccine. Results: In this study, the basic solution buffer and a serious of potential stabilizers, such as carbohydrate, amino acid, antioxidant, salt and antioxidant were screened for evaluating stable effect on FMDV antigen with aid of high performance size exclusion chromatography (HPSEC). On this basis, orthogonal experiment was performed to optimize and finally confirm the formulation. Anti-aging test were carried out to asses the efficiency of formulation on vaccine stability and the results showed that the vaccine was more stabler either stored at 37℃or 4℃. Moreover, physicochemical monitoring revealed that formulation had no influence on the properties of vaccine. The combined results suggested that the novel solution buffer would lower degradation and prolong shelf life of vaccine. In a word, the novel buffer is beneficial to make FMD vaccine more stable and effective, reducing the dependence on cold delivery and storage. This study also provides insight into the processes of optimization and inactivated vaccine development.