# US 2025/0144037 A1 · mRNA VACCINE COMPOSITION WITH IMPROVED STORAGE STABILITY

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- Number: US 2025/0144037 A1
- Document ID: US20250144037A1
- Status: Published application
- Kind: A1
- Application number: 18/941,843
- Filed: 2024-11-08
- Published: 2025-05-08
- Earliest claimed: 2023-11-08
- Assignees: Hongik University Industry-Academia Cooperation Foundation; Luca Aicell, Inc.; Korea National Institute of Health
- Applicants: Hongik University Industry-Academia Cooperation Foundation; Luca Aicell, Inc.; Korea National Institute of Health
- Inventors: Minsub CHUNG; Kyongman AN; Taehoon KIM; Minjeong KIM; Hyunjin KIM; Taekyoung LEE; Dokeun KIM; Hye Sook JEONG; Hyeon Guk KIM; Jin-Seung YUN
- Web page: https://patentgrep.com/patent/US20250144037A1

## CPC

- 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 9/5123: {Organic compounds, e.g. fats, sugars}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/0011: {Cancer antigens}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- 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

Provided are a mRNA vaccine composition with improved storage stability and a method of improving storage stability of the vaccine composition.

## Claims

### Claim 1

A vaccine composition with improved storage stability, comprising: a mRNA encapsulated within a lipid nanoparticle; and a stabilizer consisting of glycerol.

### Claim 2 (depends on 1)

The vaccine composition with improved storage stability, according to claim 1, wherein the glycerol is comprised in an amount of 10% (w/v) to 30% (w/v).

### Claim 3 (depends on 1)

The vaccine composition with improved storage stability, according to claim 1, wherein the glycerol is comprised in an amount of 30% (w/v).

### Claim 4 (depends on 1)

The vaccine composition with improved storage stability, according to claim 1, wherein the vaccine composition is manufactured by a low-temperature decompression concentration.

### Claim 5 (depends on 4)

The vaccine composition with improved storage stability, according to claim 4, wherein the low-temperature decompression concentration is performed at 4° C.

### Claim 6 (depends on 1)

The vaccine composition with improved storage stability, according to claim 1, wherein the mRNA comprises one or more selected from the group consisting of cancer antigens and infectious disease antigens.

### Claim 7

A method of improving storage stability of a vaccine composition comprising:
a step of preparing lipid nanoparticles encapsulating a mRNA;
a step of treating glycerol;
a step of concentrating.

### Claim 8 (depends on 7)

The method of improving storage stability of a vaccine composition according to claim 7, wherein the glycerol is comprised in an amount of 10% (w/v) to 30% (w/v).

### Claim 9 (depends on 7)

The method of improving storage stability of a vaccine composition according to claim 7, wherein the glycerol is comprised in an amount of 30% (w/v).

### Claim 10 (depends on 7)

The method of improving storage stability of a vaccine composition according to claim 7, wherein the concentration process is a low-temperature decompression concentration.

### Claim 11 (depends on 10)

The method of improving storage stability of a vaccine composition according to claim 10, wherein the low-temperature decompression concentration is performed at 4° C.

### Claim 12 (depends on 7)

The method of improving storage stability of a vaccine composition according to claim 7, wherein the mRNA comprises one or more selected from the group consisting of cancer antigens and infectious disease antigens.