Abstract

SEGURA-SILVA, RUTDALI M. et al. THERMAL STABILITY STUDIES OVER ACTIVE PHARMACEUTICAL INGREDIENT OF GAVAC ^® VACCINE. Rev.Bio.Agro [online]. 2018, vol.16, n.2, pp.58-66. ISSN 1692-3561.  https://doi.org/10.18684/bsaa.16n2.1166.

Currently the thermal stability studies constitute fundamental stages during the development of biotechnological processes, since through them the optimum conditions that must be taken into account during the storage and handling of the different vaccines obtained are determined. In the present work two thermal stability studies are carried out on the Active Pharmaceutical Ingredient (API) of Gavac® vaccine, related with: 1) Increment of the validity time of the API to 30 days at a storage temperature of 2 - 8ºC, and 2) Implementation of the number of times that the API can be frozen/defrosted over a time period of 90 days at a temperature of - 20ºC, without affecting the quality parameters established by the Quality Control system of the Center of Genetic Engineering and Biotechnology of Camagüey. According to the results obtained it can be concluded that the API of Gavac® vaccine is stable for 30 days at a temperature of 2 - 8ºC, and that it can be subjected to 5 freezing/defrosting operations for a time period of 90 days at - 20ºC of temperature without affecting negatively its main quality parameters.

Keywords : Thermal stability; Active Pharmaceutical Ingredient; Quality control.

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