# US 8,772,240 B2 · Ethanol dependence of alpha1 antitrypsin C-terminal lys truncation by basic carboxypeptidases

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- Number: US 8,772,240 B2
- Document ID: US8772240B2
- Status: Granted
- Kind: B2
- Application number: 11/749,944
- Filed: 2007-05-17
- Published: 2007-11-29
- Granted: 2014-07-08
- Earliest claimed: 2006-05-19
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Peter Matthiessen; Alfred Weber; Peter Turecek; Hans-Peter Schwarz
- Inventors: Peter Matthiessen; Alfred Weber; Peter Turecek; Hans-Peter Schwarz
- Web page: https://patentgrep.com/patent/US8772240B2

## CPC

- C07K 1/30: by precipitation
- A61K 38/57: from animals; from humans {(A61K38/553, A61K38/556 take precedence)}
- C07K 14/473: {alpha-Glycoproteins}
- C07K 14/8125: {Alpha-1-antitrypsin}
- 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)
- 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

Methods of preparing alpha-1-antiproteinase inhibitor and controlling the amount of des-lys alpha-1-antiproteinase inhibitor in the preparation, and compositions comprising the same, as well as methods of treatment using the same are provided.

## Claims

### Claim 1

A method of making an alpha-1-proteinase inhibitor composition comprising des-lys aloha-1 proteinase inhibitor from human plasma, the method comprising the step of:
treating a plasma precipitate comprising alpha-1-proteinase inhibitor with ethanol at a concentration of from 30% to 50%,
wherein the plasma precipitate is selected from the group consisting of a Cohn fraction IV-1 precipitate and a Cohn fraction IV-1+IV-4 precipitate, and
wherein the amount of des-lys alpha-1-proteinase inhibitor is increased.

### Claim 2 (depends on 1)

The method of claim 1, wherein the amount of des-lys alpha-1-proteinase inhibitor in the composition treated with ethanol is more than 70% of total alpha-1-proteinase inhibitor in the composition.

### Claim 3 (depends on 1)

The method of claim 1, wherein the amount of des-lys alpha-1-proteinase inhibitor in the composition treated with ethanol is more than 75% of total alpha-1-proteinase inhibitor in the composition.

### Claim 4 (depends on 1)

The method of claim 1, comprising treating the Cohn fraction IV-1 or IV-1+IV-4 precipitate with ethanol at a final concentration of 50%.

### Claim 5 (depends on 1)

The method of claim 1, comprising treating the Cohn fraction IV-1 or IV-1+IV-4 precipitate with ethanol at a final concentration of 40%.

### Claim 6 (depends on 1)

The method of claim 1, comprising treating the Cohn fraction IV-1 or IV-1+IV-4 precipitate with ethanol at a final concentration of less than 45% but greater than 35%.

### Claim 7 (depends on 1)

The method of claim 1, comprising treating the Cohn fraction IV-1 or IV-1+IV-4 precipitate at a pH greater than pH 5.9.

### Claim 8 (depends on 1)

The method of claim 1, wherein the plasma precipitate is a Cohn fraction IV-1 precipitate.

### Claim 9 (depends on 1)

The method of claim 1, wherein the plasma precipitate is a Cohn fraction IV-1÷IV-4 precipitate.

### Claim 10 (depends on 1)

An alpha-1-proteinase inhibitor composition comprising a physiologically acceptable carrier and an amount of des-lys alpha-1-proteinase inhibitor that is more than about 70% of total alpha-1-proteinase inhibitor in the composition, the composition made using the method of claim 1.

### Claim 11 (depends on 1)

An alpha-1-proteinase inhibitor composition comprising a physiologically acceptable carrier and an amount of des-lys alpha-1-proteinase inhibitor that is more than about 75% of total alpha-1-proteinase inhibitor in the composition, the composition made using the method of claim 1.