# US 2008/0187554 A1 · Process for producing stable HIV Th-CTL peptides

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- Number: US 2008/0187554 A1
- Document ID: US20080187554A1
- Status: Published application
- Kind: A1
- Application number: 11/592,404
- Filed: 2006-11-03
- Published: 2008-08-07
- Earliest claimed: 2005-11-03
- Assignees: Wyeth
- Inventors: Lakshmi Khandke; Ranjit Sarpal; Xudong Cindy Yang
- Web page: https://patentgrep.com/patent/US20080187554A1

## CPC

- C07K 14/005: from viruses
- A61P 31/18: for HIV
- A61K 2039/55522: {Cytokines; Lymphokines; Interferons}
- C12N 2740/16122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2740/16222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2740/16322: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

A process for producing a stable formulation of hydrophobic HIV Th/CTL peptides first requires the preparation of a formulation buffer containing 12.5 mM succinic acid and 3% mannitol, and adjusting the pH of the formulation buffer to 1.7 to 2.1. The hydrophobic peptides are then dissolved in the formulation buffer, filtered and lyophilized. Prior to use, the lyophilized peptides are reconstituted with 12.5 mM sodium succinate, and then mixed with at least one adjuvant to produce an immunogenic composition that is stable at 2-8° C. for at least three hours.

## Claims

### Claim 1

A process for solubilizing hydrophobic HIV Th/CTL peptides, comprising the steps of:
(a) preparing an aqueous formulation buffer comprising 12.5 mM succinic acid and 3% mannitol;
(b) adjusting the pH of the formulation buffer to 1.7 to 2.1; and
(c) dissolving at least one hydrophobic HIV Th/CTL peptide in the formulation buffer.

### Claim 2 (depends on 1)

The process of claim 1, wherein a mixture of at least four hydrophobic HIV Th/CTL peptides are dissolved in the formulation buffer.

### Claim 3 (depends on 2)

The process of claim 2, wherein the peptide mixture comprises HIV A-Th/A-CTL (SEQ ID NO:1), B-Th/B-CTL (SEQ ID NO:2), C-Th/C-CTL (SEQ ID NO:3) and A*-Th/J-CTL (SEQ ID NO:4).

### Claim 4 (depends on 2)

The process of claim 2, wherein the peptide mixture comprises HIV A-Th/A-CTL (SEQ ID NO:1), B-Th/B-CTL (SEQ ID NO:2), C-Th/C-CTL (SEQ ID NO:3), A*Th/J-CTL (SEQ ID NO:4), A*-Th/L-CTL (SEQ ID NO:5), A*-Th/M1-CTL (SEQ ID NO:6), A*-Th/M2-CTL (SEQ ID NO:7) and A*-Th/R-CTL (SEQ ID NO:8).

### Claim 5

A process for preparing a stable formulation of hydrophobic HIV Th/CTL peptides, comprising the steps of:
(a) preparing an aqueous formulation buffer comprising 12.5 mM succinic acid and 3% mannitol, and adjusting the pH of the formulation buffer to 1.7 to 2.1;
(b) dissolving a mixture of hydrophobic HIV Th/CTL peptides in the formulation buffer;
(c) filtering the peptide formulation obtained in step (b); and
(d) lyophilizing the filtrate, whereby the lyophillized HIV Th/CTL peptides are stable at 2-8° C. for at least 24 months.

### Claim 6 (depends on 4)

The process of claim 4, wherein the mixture of hydrophobic HIV Th/CTL peptides comprises A-Th/A-CTL (SEQ ID NO:1), B-Th/B-CTL (SEQ ID NO:2), C-Th/C-CTL (SEQ ID NO:3) and A*-Th/J-CTL (SEQ ID NO:4).

### Claim 7 (depends on 4)

The process of claim 4, wherein the mixture of hydrophobic HIV Th/CTL peptides comprises A-Th/A-CTL (SEQ ID NO:1), B-Th/B-CTL (SEQ ID NO:2), C-Th/C-CTL (SEQ ID NO:3), A*Th/J-CTL (SEQ ID NO:4), A*-Th/L-CTL (SEQ ID NO:5), A*-Th/M1-CTL (SEQ ID NO:6), A*-Th/M2-CTL (SEQ ID NO:7) and A*-Th/R-CTL (SEQ ID NO:8).

### Claim 8 (depends on 4)

A process for preparing an immunogenic composition for the prevention or treatment of HIV, comprising: reconstituting the lyophilized HIV Th/CTL peptides of claim 4 with 12.5 mM sodium succinate prior to use, wherein the pH after reconstitution is 4.2 to 5.2, and mixing the reconstituted peptides with at least one adjuvant to produce an immunogenic composition that is stable at 2-8° C. for at least three hours.

### Claim 9 (depends on 8)

The process of claim 8, wherein the adjuvant is selected from the group consisting of GM-CSF and RC 529-SE, or a combination thereof.

### Claim 10 (depends on 5)

A lyophilized composition comprising hydrophobic HIV Th/CTL peptides that are stable at 2-8° C. for at least 24 months, wherein the peptides are produced by the process of claim 5.