VEGF antagonist formulations
OwnerDaniel Dix, Kelly Frye +1inventors
InventorsDaniel Dix, Kelly Frye, Susan Kautz
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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.
Claims19
A stable liquid formulation of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist, comprising a fusion protein having a receptor component consisting of an immunoglobulin-like (Ig) domain 2 of a first VEGF receptor and Ig domain 3 of a second VEGF receptor, and a multimerizing component, one or more buffers, and one or more thermal stabilizers.
6 The stable liquid formulation of claim 1, comprising 1-10 mM phosphate buffer, 1-10 mM citrate, 25-150 mM NaCl, 5-30% sucrose, 10-50 mg/ml of the fusion protein, at a pH of about 6-6.5, optionally further comprising 0.05-0.10% polysorbate.
The stable liquid formulation of claim 6, comprising 5 mM phosphate buffer, 5 mM citrate buffer, 100 mM NaCl, 25% sucrose, 25 mg/ml of the fusion protein of SEQ ID NO:4, at a pH of about 6.0.
A pre-lyophilized formulation, comprising (i) a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist, (ii) a buffer, (iii) an organic co-solvent or bulking agent, and (iv) one or more lyoprotectants, wherein the fusion protein has the amino acid sequence of SEQ ID NO:4.
A liquid stable formulation of a VEGF antagonist, comprising 1-50 mM histidine, 25-150 mM NaCl, 5-30% sucrose, and 50-100 mg/ml of the fusion protein, at a pH of about 6.0-6.5, optionally comprising 0.01-0.5% polysorbate, and optionally further comprising 0.1-5% PEG.
Dependencies are inferred from the claim text.