Journal article
Brazilian meningococcal C conjugate vaccine: Scaling up studies
Several outbreaks caused by Neisseria meningitidis group C have been occurred in different regions of Brazil. A conjugate vaccine for Neisseria meningitidis was produced by chemical linkage between periodate-oxidized meningococcal C polysaccharide and hydrazide-activated monomeric tetanus toxoid via a modified reductive amination conjugation method. Vaccine safety and immunogenicity tested in Phase I and II trials showed satisfactory results. Before starting Phase III trials, vaccine production was scaled up to obtain industrial lots under Good Manufacture Practices (GMP). Comparative analysis between data obtained from industrial and pilot scales of the meningococcal C conjugate bulk showed similar execution times in the scaling up production process without significant losses or alterations in the quality attributes of purified compounds. In conclusion, scale up was considered satisfactory and the Brazilian meningococcal conjugate vaccine production aiming to perform Phase III trials is feasible.
Authors
Languages
- English
Publication year
2015
Journal
Vaccine
Volume
33
Issue
35
Type
Journal article
Categories
- Vaccines & delivery devices
Diseases
- Meningococcal meningitis
Countries
- Brazil
Tags
- New vaccine introduction
WHO Regions
- Region of the Americas
