The United States of America, As Represented by the Secretary, Department of Health and Human Services

Glaxosmithkline Biologicals Sa

Fiocruz

Carl E Frasch

Che-Hung Robert Lee

Francesco Berti

Ivna Alana Freitas Brasileiro Da Silveira

Renata Chagas Bastos

Ellen Jessouroun

Methods for detecting in a sample the presence of an antibody to a conjugate of an antigen associated with a first carrier by a first association are disclosed. The method comprises contacting a conjugate of the antigen associated with a second carrier by a second association with said sample under conditions that allow binding of the antibody to the antigen; and introducing an agent to detect the presence of the antibody bound to said antigen. The first association and the second association are covalent associations and the first association is different from the second association. Also provided are kits, multiwell plates and conjugates that are useful in the method and further uses of the method. Also provided is a method of releasing a batch of a vaccine comprising a conjugate of an antigen associated with a first carrier by a first association and antibodies useful in this method.

Method of detecting the presence of an antibody in a sample

Methods for synthesis and manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency, such that a simplified purification process can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

Polysaccharide-protein conjugate vaccines

Methods for the manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency. Simplified purification processes can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

Process for preparing polysaccharide-protein conjugate vaccines

Abstract of the Disclosure Methods for synthesis and manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency, such that a simplified purification process can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

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Martinsburg, WV, United States of America

Carl E Frasch