Granted Patent B2

US 12,280,107 · App. 18/169,632 · Granted Apr 22, 2025

Inventors: William J. Smith (Harleysville, PA); Cecilia Giovarelli (Allentown, PA); Denise K. Nawrocki (Annandale, NJ)

Assignee: Merck Sharp & Dohme LLC

A61K39/385A61K47/10A61K47/20A61K47/26A61K47/36C07K1/1072C07K14/3156A61K2039/55A61K2039/6037A61K2039/70

Abstract

Claims (18)

1. A formulation comprising:

(i) polysaccharide-protein conjugates;

(ii) a pH buffered saline solution having a pH in the range from 5.0 to 7.5;

(iii) an aluminum salt; and

(iv) 0.2% w/v polysorbate 20 (PS-20);

wherein the polysaccharide is a S. pneumoniae polysaccharide and the protein is CRM197,

wherein the conjugates are prepared by reductive amination,

wherein 24% to 100% of the conjugates (on a total protein basis) are prepared in dimethylsulfoxide (DMSO), and

wherein S. pneumoniae polysaccharide serotypes 6A, 6B and 23F are present in the formulation and are conjugated to CRM 197 and are prepared by reductive amination in DMSO.

2. A formulation comprising:

(i) polysaccharide-protein conjugates;

(ii) a pH buffered saline solution having a pH in the range from 5.0 to 7.5;

(iii) an aluminum salt; and

(iv) 0.2% w/v polysorbate 20 (PS-20);

wherein the polysaccharide is a S. pneumoniae polysaccharide and the protein is CRM197,

wherein the conjugates are prepared by reductive amination,

wherein 24% to 100% of the conjugates (on a total protein basis) are prepared in dimethylsulfoxide (DMSO), and

wherein S. pneumoniae polysaccharide serotypes 6A, 6B, 7F, 19A, 19F and 23F are present in the formulation and are conjugated to CRM197 and are prepared by reductive amination in DMSO.

Assignments (2)

Continuity (4)

References Cited (34)