NOVEL FORMULATIONS WHICH MITIGATE AGITATION-INDUCED AGGREGATION OF IMMUNOGENIC COMPOSITIONS.

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.