We are proud to announce that the Journal of Pharmaceutical Sciences has published scientific data generated together with the University of Kansas on the stability of a novel rotavirus (RV3-BB) vaccine candidate.
The studies describe the use of two different in vitro gastric digestion models used as part of formulation development of a candidate RV3-BB vaccine. The first model is a forced-degradation, a modified version of the Baby Rossette Rice Assay, and the second model is a sequential-addition set-up under conditions that more realistically mimic conditions encountered during administration of a vaccine to infants. This work focused on addressing in vitro approaches to prescreen formulations during development of a liquid stable rotavirus live vaccine candidate. Extensive formulation development work has identified promising candidate liquid formulations, stable during a long-term at 2–8 °C. This is a significant improvement over most of the current available rotavirus vaccines. Most of them need to be stored frozen or freeze-dried.
This project was funded by a grant from the Bill & Melinda Gates Foundation (#OPP1148427) aimed to accelerate the development of a low-cost, liquid RV3-BB rotavirus vaccine for Gavi countries through formulation development and bulk process optimization.
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