Capsular polysaccharide solubilisation and combination vaccines
AssigneeGlaxosmithkline Biologicals SA
InventorPaolo Constantino
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Abstract
Precipitated bacterial capsular polysaccharides can be efficiently re-solubilized using alcohols as solvents. The invention provides a process for purifying a bacterial capsular polysaccharide, comprising the steps of (a) precipitation of said polysaccharide, followed by (b) solubilization of the precipitated polysaccharide using ethanol. CTAB can be used for step (a). The material obtained, preferably following hydrolysis and sizing, can be conjugated to a carrier protein and formulated as a vaccine. Also, in vaccines comprising saccharides from both serogroups A and C, the invention provides that the ratio (w/w) of MenA saccharide:MenC saccharide is >1.
Claims14
A process for conjugating a bacterial capsular saccharide to a carrier protein, comprising:
- purifying the saccharide, comprising the steps of (a) precipitation of the saccharide using one or more cationic detergents, followed by (b) solubilisation of the precipitated saccharide using ethanol at a final concentration of between 75% and 95%,
- conjugating the saccharide to a carrier protein, wherein the carrier protein is a bacterial toxin or toxoid, and wherein the conjugated saccharide has a saccharide:protein ratio (w/w) between 0.5:1 and 5:1,
- mixing the conjugated saccharide with a second bacterial capsular saccharide conjugated to a second carrier protein, wherein the second carrier protein is the bacterial toxin or toxoid,
- wherein the bacterial capsular saccharide is from Neisseria meningitidis serogroup A, W135 or Y, or from Haemophilus influenzae, or from Streptococcus pneumoniae.
A process for conjugating a bacterial capsular saccharide to a carrier protein, comprising:
- purifying the saccharide, comprising the steps of (a) precipitation of the saccharide using one or more cationic detergents, followed by (b) solubilisation of the precipitated saccharide using ethanol at a final concentration of between 75% and 95%,
- activating the saccharide with a cyanylating reagent, and
- conjugating the saccharide to a carrier protein, wherein the carrier protein is a bacterial toxin or toxoid,
- mixing the conjugated saccharide with a second bacterial capsular saccharide conjugated to a second carrier protein, wherein the second carrier protein is the bacterial toxin or toxoid,
- wherein the bacterial capsular saccharide is from Neisseria meningitidis serogroup A, W135 or Y, or from Haemophilus influenzae, or from Streptococcus pneumoniae.
Dependencies are inferred from the claim text.