title: Brazilian meningococcal C conjugate vaccine: Scaling up studies.
abstract: 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: Laboratório de Macromoléculas, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil. Electronic address: renata@bio.fiocruz.br.
authors: Renata Chagas
authors: RC
authors: Bastos
authors: Laboratório de Tecnologia Bacteriana, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors: Iaralice Medeiros
authors: IM
authors: de Souza
authors: Laboratório de Tecnologia Bacteriana, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors: Milton Neto
authors: MN
authors: da Silva
authors: Departamento de Vacinas Bacterianas, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors: Flavia de Paiva
authors: Fde P
authors: Silva
authors: Laboratório de Tecnologia Bacteriana, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors: Elza Scott
authors: ES
authors: Figueira
authors: Laboratório de Tecnologia Bacteriana, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors: Maria de Lurdes
authors: Mde L
authors: Leal
authors: Programa de Vacinas Bacterianas, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors: Ellen
authors: E
authors: Jessouroun
authors: Laboratório de Macromoléculas, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors: José Godinho
authors: JG
authors: da Silva
authors: Escola de Química, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
authors: Ricardo de Andrade
authors: Rde A
authors: Medronho
authors: Laboratório de Tecnologia Bacteriana, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors: Ivna Alana Freitas Brasileiro
authors: IA
authors: da Silveira
mesh_terms: D001938:Brazil; D002850:Chromatography, Gel; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D008585:Meningitis, Meningococcal / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000737:chemistry* / Q000592:standards*; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D010865:Pilot Projects; D013745:Tetanus Toxoid / Q000276:immunology; D018074:Vaccines, Conjugate / Q000737:chemistry / Q000592:standards
chemical_list: D022401:Meningococcal Vaccines; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate; C410218:serogroup C meningococcal conjugate vaccine
keywords: Brazilian meningococcal C conjugate vaccine; Modified reductive amination; Scaling up studies