PREPARATION AND CHARACTERIZATION OF LOTS OF LYOPHILIZED STREPTOCOCCUS PNEUMONIAE STRAINS FOR THE DEVELOPMENT AND PRODUCTION OF VACCINES

Abstract

TYPE: Abstract TOPIC: Biotechnology PURPOSE: The department responsible for the preservation of strains of the Finlay Vaccine Institute was given the task of preparing and characterizing freeze-dried batches of 10 strains of S. pneumoniae destined for the production of vaccines, from clinical isolates donated by the Institute of Tropical Medicine Pedro Kourí. Strains were previously stored at -70 Celsius degree but it was necessary to explore an alternative method for their long-term storage and safe transport, while still complying with Good Manufacturing Practices. This strains could be a starting point for future vaccine development METHODS: Each strain was grown in liquid medium, centrifuged and the pellet was re-suspended in 10% skim milk solution, adjusting the parameters for lyophilization. The characterization consisted of evaluating: viability, cultural characteristics of the colony, purity, Gram stain, growth potential in liquid medium, identity (biochemical and serological tests). They were checked for one year to assess stability. All the documentation that guarantees compliance with the GMP was prepared for each batch. RESULTS: 10 lyophilized batches were prepared and characterized. The evaluation after lyophilization showed stability over time despite the decrease in viability during the preservation process. The batches met the quality requirements necessary to constitute batches of seeds for the stage of development and production of vaccines. CONCLUSIONS: The evaluation after lyophilization was positive, indicating that it can be an alternative method of conservation. CLINICAL IMPLICATIONS: Having a well-preserved strain bank guarantees to provide productions with a high-quality biological material, available over time, with low risk of deterioration, easy to transport and distribute. DISCLOSURE: Nothing to declare. KEYWORD: Vaccine candidates, conservation, Lyophilization, strain