# US 11,306,292 B2 · Stable virus-containing composition

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- Number: US 11,306,292 B2
- Document ID: US11306292B2
- Status: Granted
- Kind: B2
- Application number: 16/611,339
- Filed: 2018-05-15
- Published: 2020-05-28
- Granted: 2022-04-19
- Earliest claimed: 2017-05-15
- Assignees: Janssen Vaccines & Prevention B.V.
- Applicants: Janssen Vaccines & Prevention B.V.
- Inventors: Ahmad Shakeb Sediq; Wouter Frank Tonnis; Martinus Anne Hobbe Capelle
- Web page: https://patentgrep.com/patent/US11306292B2

## CPC

- A61K 39/12: Viral antigens
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 39/285: Vaccinia virus or variola virus
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- 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 2039/525: {Virus}
- C12N 2710/24121: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2710/24122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2710/24134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Described are compositions comprising enveloped viruses that are not MVA, a sulfate salt at a concentration of about 5 mM to about 300 mM and a buffer, and the composition has a pH of about 6.0 to about 8.5. It also discloses methods for stabilizing an enveloped virus composition by preparing said viral formulation.

## Claims

### Claim 1

A composition comprising
a) an enveloped virus;
b) a buffer selected from the group consisting of a Tris buffer, a phosphate buffer, a histidine, a citrate buffer, and a citrate/phosphate buffer, at a concentration of about 5 to about 40 mM;
c) a sulfate salt selected from the group consisting of sodium sulfate, potassium sulfate, magnesium sulfate and an ammonium sulfate at a concentration of about 5 mM to about 300 mM; and
d) glycerol at a concentration ranging between about 1% (w/w) to 6% (w/w),
wherein said composition has a pH of about 6.0 to about 8.5, and the enveloped virus is not a MVA virus that expresses a Filovirus antigen.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the enveloped virus is not a MVA virus.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the enveloped virus is selected from the group consisting of influenza viruses, respiratory syncytial viruses (RSV), and herpes simplex viruses.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the enveloped virus is a recombinant enveloped virus.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the composition is a liquid composition or liquid frozen.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the buffer is a Tris buffer at a pH of about 6.5 to about 8.5, or a pH of about 7.5 to about 8.5, or a pH of about 8; or wherein the buffer is a phosphate buffer at a pH of about 6.5 to about 8.5, or a pH of about 6.8 to about 7.8, or a pH of about 7.0 to about 7.5.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the sulfate salt concentration is about 5 mM to about 150 mM.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the buffer is a Tris buffer at a concentration of about 10 mM, the sulfate salt is sodium sulfate at a concentration of about 100 mM, and wherein said composition has a pH of about 8; or wherein the buffer is a phosphate buffer at a concentration of about 10 mM, the sulfate salt is sodium sulfate at a concentration of about 100 mM, and wherein said composition has a pH of about 7.5.

### Claim 9 (depends on 1)

The composition of claim 1, further comprising sodium chloride at a concentration of about 10 mM to about 100 mM.

### Claim 10 (depends on 1)

The composition of claim 1, wherein the glycerol concentration is about 5% (w/w).

### Claim 11 (depends on 1)

A pharmaceutical composition comprising the composition of claim 1.

### Claim 12 (depends on 1)

A method of preparing the composition of claim 1, comprising combining
a) the enveloped virus;
b) the buffer selected from the group consisting of a Tris buffer, a phosphate buffer, a histidine, a citrate buffer, and a citrate/phosphate buffer, at a concentration of about 5 to about 40 mM;
c) the sulfate salt selected from the group consisting of sodium sulfate, potassium sulfate, magnesium sulfate and an ammonium sulfate at a concentration of about 5 mM to about 300 mM; and
d) glycerol at a concentration ranging between about 1% (w/w) to 6% (w/w),
wherein said composition has a pH of about 6.0 to about 8.5.

### Claim 13 (depends on 1)

A method of stabilizing an enveloped virus, comprising preparing the composition of claim 1 comprising the enveloped virus.

### Claim 14 (depends on 13)

The method of claim 13, further comprising storing the composition at a temperature from 2 degrees centigrade to 8 degrees centigrade.
