The stabilization of proteins

A - Human Necessities – 61 – K

Patent

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Details

A61K 47/18 (2006.01) A61K 9/08 (2006.01) A61K 38/27 (2006.01) A61K 38/44 (2006.01) A61K 39/29 (2006.01) A61K 47/14 (2006.01) A61K 47/22 (2006.01)

Patent

CA 2674765

An aqueous composition having increased protein stability is obtained by : a. determining a pH at which the protein has stability at the desired temperature; b. adding to the composition at least one displacement buffer wherein the displacement buffer has a pKa that is at least 1 unit greater or less than the pH of step (a); and c. adjusting the pH of the composition to the pH of step (a); wherein the aqueous composition does not comprise a conventional buffer at a concentration greater than about 2 mM and wherein the conventional buffer has a pKa that is within 1 unit of the pH of step (a).

Selon l'invention, une composition aqueuse ayant une stabilité accrue de protéines est obtenue par les opérations consistant à : a. déterminer un pH auquel la protéine a une stabilité à la température désirée; b. ajouter à la composition au moins un tampon de déplacement, le tampon de déplacement ayant un pKa qui est d'au moins 1 unité supérieur ou inférieur au pH de l'étape (a); et c. ajuster le pH de la composition au pH de l'étape (a), la composition aqueuse ne comprenant pas de tampon classique à une concentration supérieure à environ 2 mM, et le tampon classique ayant un pKa qui se trouve dans la 1 unité du pH de l'étape (a).

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