Process for manufacturing vaccines
AssigneeGlaxosmithkline Biologicals SA
InventorsRalph Leon Biemans, Pierre Duvivier
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Abstract
The present application discloses a method for making an immunogenic composition comprising an improved way of conducting saccharide-protein conjugation reactions using carbodiimide condensation chemistry. Depending on the nature of the saccharide or protein carrier involved, the quality of the conjugate may be improved by adding one of the reaction components slowly to the reaction mixture. In addition, the conjugate is mixed with a staphylococcal antigen. Immunogenic compositions are further provided comprising the saccharide-protein conjugates made by the methods disclosed.
Claims21
A method of making an immunogenic composition comprising a conjugation step of conjugating a saccharide to a protein carrier to make a saccharide-protein conjugate using carbodiimide condensation chemistry, wherein the saccharide comprises (for instance as part of its repeating unit), or has been derivatised to comprise, amino and/or carboxyl groups, and wherein the protein carrier comprises, or has been derivatised to comprise, amino and/or carboxyl groups, comprising the steps of:
- I)—if the protein carrier comprises both amino and carboxyl groups and the saccharide comprises either amino or carboxyl groups:
- a) mixing the saccharide and aliquot of carbodiimide required to perform the conjugation, and
- b) adding the aliquot of protein carrier required over a period of 35 seconds to 6 hours;
- II)—if the saccharide comprises both amino and carboxyl groups and the protein carrier comprises either amino or carboxyl groups:
- a) mixing the protein carrier and aliquot of carbodiimide required to perform the conjugation, and
- b) adding the aliquot of saccharide required over a period of 10 minutes to 4 hours;
- III)—if the saccharide comprises both amino and carboxyl groups and the protein carrier comprises both amino and carboxyl groups:
- a) mixing the protein carrier and saccharide, and
- b) adding the aliquot of carbodiimide required to perform the conjugation over a period of 35 seconds to 6 hours;
- and a further step of mixing the saccharide-protein conjugate with a staphylococcal antigen.
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A method of conjugating a saccharide to a staphylococcal protein carrier using carbodiimide condensation chemistry, wherein the saccharide comprises (for instance as part of its repeating unit), or has been derivatised to comprise, amino and/or carboxyl groups, and wherein the protein carrier comprises, or has been derivatised to comprise, amino and/or carboxyl groups, comprising the steps of:
- I)—if the staphylococcal protein carrier comprises both amino and carboxyl groups and the saccharide comprises either amino or carboxyl groups:
- a) mixing the saccharide and aliquot of carbodiimide required to perform the conjugation, and
- b) adding the aliquot of staphylococcal protein carrier required over a period of 35 seconds to 6 hours;
- II)—if the saccharide comprises both amino and carboxyl groups and the protein carrier comprises either amino or carboxyl groups:
- a) mixing the staphylococcal protein carrier and aliquot of carbodiimide required to perform the conjugation, and
- b) adding the aliquot of saccharide required over a period of 35 seconds to 6 hours;
- III)—if the saccharide comprises both amino and carboxyl groups and the protein carrier comprises both amino and carboxyl groups:
- a) mixing the staphylococcal protein carrier and saccharide, and
- b) adding the aliquot of carbodiimide required to perform the conjugation over a period of 35 seconds to 6 hours.
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Dependencies are inferred from the claim text.