Stable Formulation of a Therapeutic Protein
AssigneeArecor Limited
InventorJan Jezek
Life of this patent
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Abstract
An aqueous composition comprising a therapeutic protein further characterized in that (i) the pH of the composition is adjusted to be between about 5.9 and 6.3, preferably about 6.1; (ii) the composition comprises at least one displaced buffer having a pKa within 1 to 3 pH units of the pH of the composition; (iv) the osmolarity of the composition is between 150-500 mOsm/L.
Claims35
An aqueous composition comprising a therapeutic protein, characterized in that:
- (i) the pH of the composition is adjusted to be between about 5.9 and 6.3;
- (ii) the composition comprises at least one displaced buffer having a pKa within 1 to 3 pH units of the pH of the composition;
- and
- (iii) the osmolarity of the composition is between 150-500 mOsm/L.
13-14. (canceled)
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An aqueous composition comprising human growth hormone, characterized in that following incubation at (a) 40° C. for 4 weeks or (b) 25° C. for 18 weeks
- (i) no visible precipitation is observed in the composition;
- and
- (ii) >95% of the monomeric form of human growth hormone is retained in the composition as measured by size-exclusion chromatography.
22-23. (canceled)
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Dependencies are inferred from the claim text.