Novel formulations which stabilize and inhibit precipitation of immunogenic compositions

Abstract

The present invention addresses an ongoing need in the art to improve the stability of immunogenic compositions such as polysaccharide-protein conjugates and protein immunogens. The invention broadly relates to novel formulations which stabilize and inhibit precipitation of immunogenic compositions. More particularly, the invention described hereinafter, addresses a need in the art for formulations which stabilize and inhibit particulate formation (e.g., aggregation, precipitation) of immunogenic compositions which are processed, developed, formulated, manufactured and/or stored in container means such as fermentors, bioreactors, vials, flasks, bags, syringes, rubber stoppers, tubing and the like.

1 - 36 . (canceled) 
     
     
         37 . A formulation which stabilizes a  N. meningitidis  2086 protein composition, the formulation comprising (i) a pH buffered saline solution, wherein the buffer has a pKa of about 3.5 to about 7.5, (ii) a surfactant and (iii) a  N. meningitidis  2086 protein. 
     
     
         38 . The formulation of  claim 37 , wherein the surfactant is polysorbate 80. 
     
     
         39 . The formulation of  claim 37 , wherein the formulation further comprises an aluminum salt adjuvant. 
     
     
         40 . (canceled)