You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 10,071,136


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,071,136
Title:Stable liquid formulations of recombinant fusion proteins
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.
Inventor(s): Wang; Yinjue (Jiangsu, CN), Li; Junfeng (Jiangsu, CN), Huang; Xiaole (Jiangsu, CN)
Assignee: INNOVENT BIOLOGICS, INC. (Jiangsu, CN)
Application Number:15/513,542
Patent Claims:1. 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 phosphate 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; the pH of the liquid formulation is from 5.5 to 7.0; 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.

2. The liquid formulation of claim 1, wherein the amino acid has a concentration of 70 to 260 mmol/L.

3. The liquid formulation of claim 1, wherein the polyol has a concentration of 3-10 wt %.

4. The liquid formulation of claim 1, wherein the pH of the liquid formulation is from 5.5 to 7.0, and the liquid formulation comprises: TABLE-US-00012 the recombinant fusion protein 5-45 mg/ml; phosphate salt 5-15 mmol/L; arginine 50-100 mmol/L; sucrose 2-8 wt %; polysorbate 20 0.02-0.06 wt %;

and the sterile water for injection.

5. The liquid formulation of claim 1, wherein the buffer salt is phosphate salt, acetate salt or any combination thereof, and has a concentration of 8 to 22 mmol/L.

6. The liquid formulation of claim 1, wherein the buffer salt is phosphate salt.

7. A kit comprising the liquid formulation according to claim 1 and a container containing the liquid formulation.

8. A method for treating age-related macular degeneration comprising administering to a subject in need thereof the liquid formulation according to claim 1 or the kit according to claim 7.

9. The method of claim 8, wherein the age-related macular degeneration is wet age-related macular degeneration.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.