Merck Sharp + Dohme Corp.

Jayme L Cannon

Patrick L Ahl

Jeffrey T Blue

Michael J Caulfield

David S Thiriot

Gabriel M Lobel

The present invention relates to methods for preparing amorphous aluminum hydroxyphosphate. An aluminum salt and a phosphate solution are co-mixed at a constant ratio in the presence of a buffer. Preferably, an excess of the phosphate solution is used to act as a buffer. Due to the presence of a buffer, the pH is maintained constant during reaction (after initial rapid equilibration) without active adjustment. The methods are particularly applicable for the large scale manufacturing of aluminum phosphate adjuvant. Aluminum phosphate is used as an adjuvant in vaccine formulations, particularly those including a protein or saccharide antigen.

Method for preparation of aluminum hydroxyphosphate adjuvant

The present invention provides a multivalent immunogenic composition having 15 distinct polysaccharide-protein conjugates. Each conjugate consists of a capsular polysaccharide prepared from a different serotype of(1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F or 33F) conjugated to a carrier protein, preferably CRM. The immunogenic composition, preferably formulated as a vaccine on an aluminum -based adjuvant, provides broad coverage against pneumococcal disease, particularly in infants and young children.

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Glenside, PA, United States of America

Jayme L Cannon