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US 10,293,045 B2Granted
Stable liquid formulations of recombinant fusion proteins
AssigneeInnovent Biologics, Inc.
InventorsYinjue Wang, Junfeng Li, Xiaole Huang
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Abstract
Provided is a liquid formulation that enables the stable storage of recombinant fusion proteins, comprising a recombinant fusion protein, a buffer salt, a stabilizer, and a surfactant.
Claims13
A liquid formulation of a recombinant fusion protein,
- which comprises a recombinant fusion protein, a buffer salt, a stabilizer, a surfactant and sterile water for injection, wherein,
- the recombinant fusion protein has a concentration of 5 to 45 mg/mL;
- the buffer salt is citrate salt, acetate salt or any combination thereof, and has a concentration of 5 to 25 mmol/L;
- the stabilizer is an amino acid or a combination of a polyol and an amino acid, wherein the amino acid is arginine, and the polyol is sucrose;
- the amino acid has a concentration of 50 to 350 mmol/L;
- and the polyol has a concentration of 1-15 wt %, based on total weight of the liquid formulation;
- the surfactant is polysorbate 20 and has a concentration of 0.01-0.08 wt %, based on total weight of the liquid formulation;
- and the pH of the liquid formulation is from 5.5 to 7.5;
- and
- the recombinant fusion protein is a recombinant fusion protein of human vascular endothelial growth factor receptor-antibody-human complement receptor 1 which comprises the amino acid sequence as set forth in SEQ ID NO:
- 1 or SEQ ID NO:
- 4.
9 more elements
Dependencies are inferred from the claim text.