# US 12,594,322 B2 · Liquid composition comprising protein

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- Number: US 12,594,322 B2
- Document ID: US12594322B2
- Status: Granted
- Kind: B2
- Application number: 17/274,834
- Filed: 2019-09-10
- Published: 2022-02-24
- Granted: 2026-04-07
- Earliest claimed: 2018-09-10
- Assignees: Samsung Bioepis Co., Ltd.
- Applicants: Samsung Bioepis Co., Ltd.
- Inventors: Inae Kim; Soyun Jung; Jaemin Lee; Hun Joo Lee; Yongkook Kim
- Web page: https://patentgrep.com/patent/US12594322B2

## CPC

- A61K 38/179: {for growth factors; for growth regulators}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

The present invention relates to a protein-stabilized liquid formulation and provides: a composition for protein stabilization, the composition including a stabilizer and a surfactant and not including a buffer; a protein liquid composition including the composition for stabilization and a protein; and a method of producing a protein-stabilized liquid composition which uses the composition for stabilization.

## Claims

### Claim 1

A liquid composition comprising:
(1) 5 mg/ml to 300 mg/ml of aflibercept;
(2) a stabilizer comprising a sugar; and
(3) a surfactant,
wherein the pH of the liquid composition is in a range of 4 to 8, and
wherein the liquid composition does not comprise any of the buffers selected from the group consisting of phosphoric acid, acetic acid, citric acid, succinic acid, carbonic acid, histidine, aspartic acid, and glutamic acid, or a pharmaceutically acceptable salt of the buffer.

### Claim 2 (depends on 1)

The liquid composition of claim 1, wherein the sugar comprises at least one selected from the group consisting of trehalose, sucrose, and glucose.

### Claim 3 (depends on 1)

The liquid composition of claim 1, wherein the stabilizer comprises at least one selected from the group consisting of 1 to 20% (w/v) of trehalose, and 1 to 20% (w/v) of sucrose.

### Claim 4 (depends on 1)

The liquid composition of claim 1, wherein the stabilizer does not comprise sodium chloride.

### Claim 5 (depends on 1)

The liquid composition of claim 1, wherein the surfactant is a non-ionic surfactant.

### Claim 6 (depends on 1)

The liquid composition of claim 1, wherein the surfactant is comprised in an amount of 0.001 to 3% (w/v) based on the total amount of the composition.

### Claim 7 (depends on 1)

The liquid composition of claim 1, wherein the liquid composition is isotonic.

### Claim 8 (depends on 1)

The liquid composition of claim 1, wherein the liquid composition is for intravitreal administration.

### Claim 9 (depends on 8)

The liquid composition of claim 8, wherein the stabilizer does not comprise sodium chloride.

### Claim 10 (depends on 1)

An injection for intravitreal administration, the injection comprising the liquid composition of claim 1.

### Claim 11

A liquid composition comprising:
(1) aflibercept;
(2) a stabilizer comprising a sugar; and
(3) a surfactant,
wherein the pH of the liquid composition is in a range of 5.7 to 6.7, and
wherein the liquid composition does not comprise any of the buffers selected from the group consisting of phosphoric acid, acetic acid, citric acid, succinic acid, carbonic acid, histidine, aspartic acid, and glutamic acid, or a pharmaceutically acceptable salt of the buffer.

### Claim 12 (depends on 11)

The liquid composition of claim 11, wherein the liquid composition is for intravitreal administration.