Mario Landys Chovel Cuervo, Cuba
Finlay Institute of Vaccine Lyophilization and Strain Conservation Laboratory of IFVAuthor Of 1 Presentation
DEVELOPMENT AND CHARACTERIZATION OF STREPTOCOCCUS PNEUMONIAE REFERENCE LOTS OF CLINICAL ISOLATED FOR THE PRODUCTION OF VACCINES (ID 259)
Abstract
Background
Our laboratory has the task of developing and characterizing the reference seeds of 25 serotypes of clinical isolates donated by the Pedro Kourí Tropical Medicine Institute, cultivating them in liquid culture media, free of animal origin and complying with GMP. S. pneumoniae is a microorganism with special nutritional requirements for its growth and is very sensitive to conservation processes. The proper conservation of the strains directly impacts the production of vaccines.
Methods
Each isolation strain was grown in solid medium supplemented with 10% sheep blood and subsequently liquid medium. 15% glycerol was used as a cryoprotective additive. The characterization consisted of: viability, cultural characteristics of the colony, purity, Gram staining, growth potential in liquid medium, Identity (biochemical and serological tests). Each batch was made a file with all the documentation that guarantees compliance with the BPM.
Results
Of the 25 strains worked, it was possible to recover 24 and develop batches of reference seeds that met the required quality specifications and the controls after freezing were positive, indicating that there was no involvement in the process
Conclusions
The batches elaborated and characterized fulfilled the quality requirements necessary to constitute reference seed lots for the stage of development and production of vaccines.