title: Determination of free polysaccharide in Vi glycoconjugate vaccine against typhoid fever.
abstract: Glycoconjugate vaccines based on the Vi capsular polysaccharide directed against Salmonella enterica serovar Typhi are licensed or in development against typhoid fever, an important cause of morbidity and mortality in developing countries. Quantification of free polysaccharide in conjugate vaccines is an important quality control for release, to monitor vaccine stability and to ensure appropriate immune response. However, we found that existing separation methods based on size are not appropriate as free Vi non-specifically binds to unconjugated and conjugated protein. We developed a method based on free Vi separation by Capto Adhere resin and quantification by HPAEC-PAD. The method has been tested for conjugates of Vi derived from Citrobacter freundii with different carrier proteins such as CRM197, Tetanus Toxoid and Diphtheria Toxoid.
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy. Electronic address: carlo.x.giannelli@gsk.com.
authors.forename: C
authors.initials: C
authors.lastname: Giannelli
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Cappelletti
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Di Benedetto
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Pippi
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Arcuri
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Di Cioccio
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: L B
authors.initials: LB
authors.lastname: Martin
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Saul
authors.affiliation: GSK Vaccines Institute for Global Health S.r.l. (former Novartis Vaccines Institute for Global Health NVGH), Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Micoli
mesh_terms: D002850:Chromatography, Gel / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D006001:Glycoconjugates / Q000032:analysis* / Q000627:therapeutic use; D006801:Humans; D011135:Polysaccharides, Bacterial / Q000032:analysis*; D012485:Salmonella typhi; D014435:Typhoid Fever / Q000517:prevention & control; D014436:Typhoid-Paratyphoid Vaccines / Q000032:analysis* / Q000627:therapeutic use; D018074:Vaccines, Conjugate / Q000032:analysis / Q000627:therapeutic use
chemical_list: D006001:Glycoconjugates; D011135:Polysaccharides, Bacterial; D014436:Typhoid-Paratyphoid Vaccines; D018074:Vaccines, Conjugate
keywords: Conjugate vaccine; Free saccharide; Quantification method; Salmonella Typhi; Vi polysaccharide