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Bio\u2010<jats:styled-content style=\"fixed-case\">M<\/jats:styled-content>anguinhos\/<jats:styled-content style=\"fixed-case\">F<\/jats:styled-content>iocruz is developing a conjugate vaccine by covalent attachment of capsular polysaccharide to hydrazide\u2010activated 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 <jats:italic><jats:styled-content style=\"fixed-case\">N<\/jats:styled-content>. meningitidis<\/jats:italic> group <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content> vaccine using <jats:styled-content style=\"fixed-case\">CE<\/jats:styled-content>. <jats:styled-content style=\"fixed-case\">CZE<\/jats:styled-content> 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.<\/jats:p>","DOI":"10.1002\/elps.201300298","type":"journal-article","created":{"date-parts":[[2013,9,3]],"date-time":"2013-09-03T08:21:33Z","timestamp":1378196493000},"page":"3221-3226","source":"Crossref","is-referenced-by-count":10,"title":["Single validation of <scp>CE<\/scp> method for determining free polysaccharide content in a <scp>B<\/scp>razilian meningococcal <scp>C<\/scp> conjugate vaccine"],"prefix":"10.1002","volume":"34","author":[{"given":"Iaralice Medeiros","family":"de Souza","sequence":"first","affiliation":[{"name":"Laborat\u00f3rio de Tecnologia Bacteriana Bio\u2010Manguinhos Funda\u00e7\u00e3o Oswaldo Cruz Rio de Janeiro Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milton Neto","family":"da Silva","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Tecnologia Bacteriana Bio\u2010Manguinhos Funda\u00e7\u00e3o Oswaldo Cruz Rio de Janeiro Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elza Scott","family":"Figueira","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Tecnologia Bacteriana Bio\u2010Manguinhos Funda\u00e7\u00e3o Oswaldo Cruz Rio de Janeiro Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"de Lourdes Leal","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Tecnologia Bacteriana Bio\u2010Manguinhos Funda\u00e7\u00e3o Oswaldo Cruz Rio de Janeiro Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen","family":"Jessouroun","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Tecnologia Bacteriana Bio\u2010Manguinhos Funda\u00e7\u00e3o Oswaldo Cruz Rio de Janeiro Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shirley","family":"de Mello Pereira Abrantes","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Alimentos e Contaminantes Departamento de Qu\u00edmica Instituto Nacional de Controle de Qualidade em Sa\u00fade Funda\u00e7\u00e3o Oswaldo Cruz Rio de Janeiro Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivna Alana Freitas Brasileiro","family":"da Silveira","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Tecnologia Bacteriana Bio\u2010Manguinhos Funda\u00e7\u00e3o Oswaldo Cruz Rio de Janeiro Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,10,18]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2007.07.037"},{"key":"e_1_2_7_3_1","unstructured":"World Health Organization WHO Technical Report Series No. 932 2004 http:\/\/whqlibdoc.who.int\/trs\/WHO_TRS_932_eng.pdf."},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1084\/jem.129.6.1349"},{"key":"e_1_2_7_5_1","first-page":"259","volume":"103","author":"Lei Q. 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