Methods for Production of Capsular Polysaccharide Protein Conjugates from Streptococcus Pneumoniae Serotype 19F
AssigneeMerck Sharp & Dohme Corp.
InventorsMichael Albert Winters, John E. MacNair
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Abstract
The present invention provides a method of producing a polysaccharide-protein conjugate with capsular polysaccharide from Streptococcus pneumoniae serotype 19F conjugated to a carrier protein. The method includes a prolonged incubation step prior to filtration to remove free polysaccharide.
Claims20
A method for the production of a stable polysaccharide-carrier protein conjugate, wherein the polysaccharide-carrier protein conjugate comprises Streptococcus pneumoniae serotype 19F capsular polysaccharide covalently linked to a carrier protein, from a post conjugation reaction mixture comprising Streptococcus pneumoniae serotype 19F capsular polysaccharide covalently linked to a carrier protein and free serotype 19F polysaccharide, the method comprising the steps of:
- a) incubating said mixture for a minimum of 48 hours at a temperature ranging from 15-25° C. in a buffer;
- and
- b) performing size separation under conditions that allow removal of free polysaccharide;
- wherein the pH of the incubation is 5.0 to 9.0;
- and wherein the carrier protein is CRM197.
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Dependencies are inferred from the claim text.