Accelerated stability study of the active pharmaceutical ingredient Bm86/pP0 by arrhenius method
DOI:
https://doi.org/10.5377/nexo.v36i02.15993Keywords:
Arrhenius equation, Accelerated stability, Bm86 protein, Temperature, Shelf lifeAbstract
The study of protein stability is currently an essential process for the development of vaccine products that contain these as an active ingredient. This work was carried out at the Center for Genetic Engineering and Biotechnology of Camagüey, where the Technological Development area is currently working on the design of a vaccine against ticks. The objective of this work was to determine the inactivation time of the protein Bm86 carrying the peptide P0, applying accelerated studies of heat stress in order to predict the stability of the vaccine against ticks, based on the Arrhenius equation. Different studies were also carried out to analyze the possible inactivation pathways of the Bm86 protein. The results obtained indicated that at a storage temperature between 2 °C and 8 °C, the protein, as an active pharmaceutical ingredient, has a predictive duration time of approximately 2.5 years before 10% of it is inactivated.
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