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Bastos R.C.,Laboratorio Of Macromoleculas | de Souza I.M.,Laboratorio Of Tecnologia Bacteriana | da Silva M.N.,Laboratorio Of Tecnologia Bacteriana | Silva F.D.P.,Bio Manguinhos | And 6 more authors.
Vaccine | Year: 2015

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. © 2015 Elsevier Ltd.

De Souza I.M.,Laboratorio Of Tecnologia Bacteriana | da Silva M.N.,Laboratorio Of Tecnologia Bacteriana | Figueira E.S.,Laboratorio Of Tecnologia Bacteriana | de Lourdes Leal M.,Laboratorio Of Tecnologia Bacteriana | And 3 more authors.
Electrophoresis | Year: 2013

Neisseria meningitidis group C is an encapsulated bacterium that causes several diseases and is associated with high mortality rates, thereby constituting a serious public health problem. Bio-Manguinhos/Fiocruz is developing a conjugate vaccine by covalent attachment of capsular polysaccharide to hydrazide-activated tetanus toxoid through reductive amination. It is necessary to quantify free components as a quality control process to prevent exacerbated adverse reactions and/or attenuation of vaccine immunogenicity. Thus, this study aimed to develop and validate a quality control method appropriate for the separation and quantification of free polysaccharide present in this conjugate N. meningitidis group C vaccine using CE. CZE was used to remove unbound polysaccharide, and the electrophoretic conditions were varied to optimize resolution. We were able to develop and validate the proposed method, which was linear and showed a matrix effect. Repeatability and partial reproducibility of the method were also evaluated. The robustness results showed that control of temperature is required for reliable results. The validated method will be used to evaluate the conjugate batches submitted for Phase III clinical studies and for routine quality control of the conjugate vaccine. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Leal M.L.M.,Laboratorio Of Tecnologia Bacteriana | Pereira D.S.G.,Laboratorio Of Tecnologia Bacteriana | Jessouroun E.,Laboratorio Of Tecnologia Bacteriana | Couto M.A.P.G.,Federal University of Rio de Janeiro | Pereira Jr. N.,Federal University of Rio de Janeiro
Electronic Journal of Biotechnology | Year: 2011

Streptococcus pneumoniae (pneumococcus) is among the most significant causes of bacterial disease in humans. Capsular polysaccharide (CPS) production is essential for pneumococcal virulence. Pneumococcal CPS has been widely used as vaccine antigen. This study is focused on the influence of culture conditions of Streptococcus pneumoniae serotype 14 as for developing an industrial method for polysaccharide production. The pH proved to be a highly important variable in batchwise culture. Using the pH control all glucose added was consumed resulting in a four-fold increase in polysaccharide productivity relative to cultivation without pH control. S. pneumoniae is a lactic acid bacterium, so named for its primary metabolic byproduct (lactate), which has an inhibitory effect on cell growth in concentrations ranging from 4 to 5 g/L. An increase of 30% in polysaccharide productivity was observed using glucose pulses with 5.5 hrs of growth, resulting in a maximum polysaccharide concentration of 185.2 mg/L. Our data suggest the possibility of using a medium of non-animal origin and employing pH control for the cultivation of pneumococcus to produce a polysaccharide vaccine. © 2011 by Pontificia Universidad Católica de Valparaíso, Chile.

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