Stabilisation of Proteins
OwnerJan Jezek, Charles Potterinventors
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Abstract
A dry composition for use in therapy or diagnosis, obtainable by drying an aqueous composition comprising a protein and one or more displacement buffers, wherein the pH of the aqueous composition is such that the protein is stable, wherein the or each displacement buffer has a pKa that is at least 1 unit greater or less than the pH of the aqueous composition, and wherein the aqueous composition is substantially free of a conventional buffer having a pKa that is within one pH unit of the pH of the aqueous composition.
Claims42
A dry composition for use in therapy or diagnosis, obtainable by drying an aqueous composition comprising a protein and one or more displacement buffers, wherein the pH of the aqueous composition is such that the protein is stable, wherein the or each displacement buffer has a pKa that is at least I unit greater or less than the pH of the aqueous composition, and wherein the aqueous composition is substantially free of a conventional buffer having a pKa that is within one pH unit of the pH of the aqueous composition.
A dry composition for use in therapy or diagnosis, comprising a protein component which is a homogeneous mixture of a protein and one or more displacement buffers which, on reconstitution in water, gives an aqueous composition having a given pH, wherein the or each displacement buffer has a pKa that is at least 1 unit greater or less than the given pH, and wherein the mixture is substantially free of a conventional buffer having a pKa that is within one pH unit of the given pH.
A process for the preparation of a pharmaceutically acceptable composition, comprising:
- (i) mixing a protein with one or more displacement buffers at a pH at which the protein is stable, wherein the or each displacement buffer has a pKa that is at least 1unit greater or less than the pH of the aqueous composition, and wherein the aqueous composition is substantially free of a conventional buffer having a pKa that is within one pH unit of the pH of the aqueous composition;
- (ii) drying the resultant aqueous composition;
- and
- (iii) combining the resultant dry composition with one or more additives.
(canceled)
Dependencies are inferred from the claim text.