A THERMOSTABLE FREEZE DRIED ROTAVIRUS VACCINE FORMULATION AND PROCESS TO PREPARE THEREOF

摘要

The present invention relates to thermostable lyophilized rotavirus vaccine formulations and methods of making the same. More particularly, the present invention relates to the use of a freeze-drying method for the preparation of a vaccine formulation, in which the vaccine formulation has improved heat-stability, ease of use and transportability and high availability and meets the requirements of development and vaccination programs in low- A thermostable liquid, powder or cake based on a manufactured rotor virus vaccine formulation is disclosed. The lyophilized rotavirus vaccine formulations together with the reconstitution buffer are engineered to be suitable for filling in a suitable packaging container / closure designed to reduce the logistical requirements of their storage.