Vaccine · 2015
Brazilian meningococcal C conjugate vaccine: Scaling up studies.
СтатьяНазвание и аннотация: Перевод в очереди
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Bastos Renata Chagas, de Souza Iaralice Medeiros, da Silva Milton Neto, Silva Flavia de Paiva, Figueira Elza Scott, Leal Maria de Lurdes, Jessouroun Ellen, da Silva José Godinho, Medronho Ricardo de Andrade, da Silveira Ivna Alana Freitas Brasileiro
Аннотация
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.