	US 12,280,107 B2
	Pneumococcal conjugate vaccine formulations
William J. Smith, Harleysville, PA (US); Cecilia Giovarelli, Allentown, PA (US); and Denise K. Nawrocki, Annandale, NJ (US)
Assigned to Merck Sharp & Dohme LLC, Rahway, NJ (US)
Filed by Merck Sharp & Dohme LLC, Rahway, NJ (US)
Filed on Feb. 15, 2023, as Appl. No. 18/169,632.
Application 18/169,632 is a continuation of application No. 17/412,550, filed on Aug. 26, 2021, abandoned.
Application 17/412,550 is a continuation of application No. 16/487,610, abandoned, previously published as PCT/US2018/018659, filed on Feb. 20, 2018.
Claims priority of provisional application 62/463,220, filed on Feb. 24, 2017.
Prior Publication US 2023/0201338 A1, Jun. 29, 2023
Int. Cl. A61K 39/385 (2006.01); A61K 47/10 (2017.01); A61K 47/20 (2006.01); A61K 47/26 (2006.01); A61K 47/36 (2006.01); C07K 1/107 (2006.01); C07K 14/315 (2006.01); A61K 39/00 (2006.01)

CPC A61K 39/385 (2013.01) [A61K 47/10 (2013.01); A61K 47/20 (2013.01); A61K 47/26 (2013.01); A61K 47/36 (2013.01); C07K 1/1072 (2013.01); C07K 14/3156 (2013.01); A61K 2039/55 (2013.01); A61K 2039/6037 (2013.01); A61K 2039/70 (2013.01)]

2 Claims

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 CRM₁₉₇and are prepared by reductive amination in DMSO.