The stability of live-attenuated viruses is very challenging due to thermal sensitivity; therefore, solid form is usually required (often freeze-dried products). Micropellet technology is a lyophilization technology that has the potential to provide greater flexibility in the presentation of a given vaccine particularly in multi-dose format or in combination of different vaccines. As a novel vaccine alternative process, this spray freeze-dried (SFD) micropellet technology was evaluated using as a model a yellow fever virus produced in Vero cells (vYF) …
When determining Self Accelerating Decomposition Temperatures (SADT) for shipment purposes, the kinetics of the decomposition reaction of the materials must be known. The simplified models assuming the first order decomposition kinetics are generally applied, however this traditional approach fails in correct SADT determination for autocatalytic and multistage overlapped reactions. For these cases a more universal, yet easily implemented, advanced method will be presented in which the detailed kinetic mechanism does not need to be known to correctly predict SADT …
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