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filingDate 2007-04-26-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2008-07-02-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AR-060665-A1
titleOfInvention FORMULATIONS THAT STABILIZE AND INHIBIT THE PRECIPITATION OF IMMUNOGENIC COMPOSITIONS
abstract Claim 1: A formulation that stabilizes a polysaccharide-protein conjugate, the formulation comprising (1) a pH buffered saline solution, wherein the buffer has a pKa of approximately 3.5 to approximately 7.5, (ii) a surfactant and (iii) one or more polysaccharide protein conjugates. Claim 2: The formulation of claim 1, wherein the formulation of the polysaccharide-protein conjugate is comprised in a container selected from one or more of the group consisting of a bottle, bottle cap, bottle closure, closure of glass, rubber glass, plastic closure, a syringe, syringe cap, syringe plunger, a vial, beaker, graduated cylinder, fermenter, bioreactor, pipe, tube, bag, jar, blister, cartridge and disposable pen. Claim 3: The formulation of claim 1, in which the container is silicone. Claim 4: The formulation of claim 1, wherein the buffer is succinate at a final concentration of 1 mM to 10 mM and pH 5.8 to 6.0. Claim 5: The formulation of claim 1, wherein the surfactant is polysorbate 80. Claim 6: The formulation of claim 5, wherein the final concentration of polysorbate 80 in the formulation is at least 0.001% to 10 Polysorbate% 80 weight / volume of the formulation. Claim 7: The formulation of claim 1, wherein the polysaccharide-protein conjugate comprises one or more of the pneumococcal polysaccharides. Claim 8: The formulation of claim 1, which further comprises one or more meningococcal polysaccharides, one or more meningococcal antigenic proteins or a combination thereof. Claim 9: The formulation of claim 1, which further comprises one or more streptococcal polysaccharides, one or more streptococcal antigenic proteins or a combination thereof.
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