Dimer VEGF antagonist formulations
First Claim
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1. A non-liquid formulation of a vascular endothelial growth factor (VEGF) antagonist made according to the steps of:
- (a) combining in a liquid solution the following excipients;
(i) about 50 mg/mL of a VEGF antagonist, which is a dimer consisting of two identical polypeptides consisting of amino acids 27-457 of SEQ ID NO;
4;
(ii) about 10 mM histidine, pH about 6.3-6.5;
(iii) about 1.5% polyethylene glycol (PEG) 3350;
(iv) about 5% sucrose; and
(v) about 1.5% glycine; and
(b) lyophilizing the combination of step (a), wherein, following storage of the lyophilized combination obtained after step (b) at 5°
C. for about 6 months, at least 98% of the VEGF antagonist is present in native conformation as measured by size exclusion chromatography upon reconstitution.
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Abstract
Formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided including a pre-lyophilized formulation, a reconstituted lyophilized formulation, and a stable liquid formulation. Preferably, the fusion protein has the sequence of SEQ ID NO:4.
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8 Claims
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1. A non-liquid formulation of a vascular endothelial growth factor (VEGF) antagonist made according to the steps of:
- (a) combining in a liquid solution the following excipients;
(i) about 50 mg/mL of a VEGF antagonist, which is a dimer consisting of two identical polypeptides consisting of amino acids 27-457 of SEQ ID NO;
4;
(ii) about 10 mM histidine, pH about 6.3-6.5;
(iii) about 1.5% polyethylene glycol (PEG) 3350;
(iv) about 5% sucrose; and
(v) about 1.5% glycine; and
(b) lyophilizing the combination of step (a), wherein, following storage of the lyophilized combination obtained after step (b) at 5°
C. for about 6 months, at least 98% of the VEGF antagonist is present in native conformation as measured by size exclusion chromatography upon reconstitution. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
- (a) combining in a liquid solution the following excipients;
Specification