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.
Claims8
A method for the production of a stable Streptococcus pneumoniae serotype 19F polysaccharide-CRM197 carrier protein conjugate, wherein the Streptococcus pneumoniae serotype 19F polysaccharide-CRM197 carrier protein conjugate comprises Streptococcus pneumoniae serotype 19F capsular polysaccharide covalently linked to a CRM197 carrier protein, the method comprising the steps of:
- a) performing a conjugation reaction wherein Streptococcus pneumoniae serotype 19F polysaccharide is covalently linked to a CRM197 carrier protein, wherein the conjugation reaction generates a reaction mixture comprising Streptococcus pneumoniae serotype 19F polysaccharide-CRM197 carrier protein conjugates and free Streptococcus pneumoniae serotype 19F polysaccharides;
- b) incubating said reaction mixture for 5-7 days at a temperature of 20-25° C. in a buffer at a pH of 6.5-7.5;
- and
- c) performing size separation under conditions that allow removal of the free Streptococcus pneumoniae serotype 19F polysaccharides.
Dependencies are inferred from the claim text.