摘要 |
The present invention provides novel formulations which mitigate agitation- induced aggregation of immunogenic compositions particularly those having polysaccharide-protein conjugates. Specifically, the novel formulations comprise a poloxamer within a molecular weight range of 1100 to 17,400 which provides significant advantages over previously used surfactants including polysorbate 80. In one embodiment, the present invention provides a multivalent immunogenic composition having 15 distinct polysaccharide-protein conjugates and a poloxamer. Each conjugate consists of a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F or 33F) conjugated to a carrier protein, preferably CRM197. |
申请人 |
MERCK SHARP & DOHME CORP. |
发明人 |
BLUE, JEFFREY T.;CANNON, JAYME;SMITH, WILLIAM J.;GREEN-TEXLER, ERIN J.;SIEGFRIED, BRETT |