Bacterial capsular polysaccharide for use as a vaccine or for protein binding in conjugate vaccines

摘要

An immunogenic composition comprising a purified group B streptococcal capsular polysaccharide, in which the purified group B streptococcal polysaccharide is produced by a process comprising - providing for isolated extraction bacterial cells, concentrated bacterial supernatants from homogenized bacterial cells or of conditioned medium or sedimented cells comprising a group B streptococcal capsular polysaccharide; - extracting the capsular polysaccharide from the cellular components, in which the cellular components include nucleic acids and proteins by contacting isolated bacterial cells, concentrated bacterial supernatants from homogenized bacterial cells or the conditioned medium or sedimented cells with a basic reagent selected from the NaOH, KOH, LiOH, NaH, NaOMe or KOtBu bases, in which the bases are used in a range of 0.5 N to 5.0 N and in which the DNA and RNA are degraded bacterial; - separating by means of hydrophobic interaction chromatography (CIH) the capsular polysaccharide extracted from the impurities resulting from the cellular components comprising proteins and nucleic acids; and - recovering the purified capsular polysaccharide; in which the group B streptococcal capsular polysaccharide is selected from the group consisting of PC of type Ia, PC of type Ib, PC of type II, PC of type III and PC of type V and in which: the PC of type Ia, after said separation stage, has Kav in the range of 0.010 - 0.005 Mw in the range of 318-311 (kg / mol) Mw / Mn in the range of 1.35 - 1.31; the type Ib PC, after said separation stage, has Kav in the range of 0.191-0.150 Mw in the range of 218-170 (kg / mol) Mw / Mn in the range of 1.61-1.20; the type II PC, after said separation stage, has Kav in the range of 0.152-0.115 Mw in the range of 289-246 (kg / mol) Mw / Mn in the range of 1.46; the type III PC, after said separation stage, has Kav in the range of 0.343-0.268 Mw in the range of 108-104 (kg / mol) Mw / Mn in the range of 1.24-1.22; the type V PC, after said separation stage, has Kav in the range of 0.257-0.156 Mw in the range of 179-92 (kg / mol) Mw / Mn in the range of 1.28-1.15. **Formula**