# US 2014/0193395 A1 · Secretory iga compositions, methods of making and methods of use thereof

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- Number: US 2014/0193395 A1
- Document ID: US20140193395A1
- Status: Published application
- Kind: A1
- Application number: 13/734,426
- Filed: 2013-01-04
- Published: 2014-07-10
- Earliest claimed: 2013-01-04
- Assignees: Wisconsin Alumni Research Foundation
- Applicants: Wisconsin Alumni Research Foundation
- Inventors: Jordan Marshall Sand; Mark Eric Cook
- Web page: https://patentgrep.com/patent/US20140193395A1

## CPC

- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- A23K 20/147: Polymeric derivatives, e.g. peptides or proteins
- A23K 50/10: for ruminants
- A23K 50/20: for horses
- A23K 50/30: for swines
- A23K 50/40: for carnivorous animals, e.g. cats or dogs
- A23K 50/75: for poultry
- A23K 50/80: for aquatic animals, e.g. fish, crustaceans or molluscs
- A23L 33/17: Amino acids, peptides or proteins
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- C07K 1/30: by precipitation
- C07K 16/18: against material from animals or humans
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K 2039/505: {comprising antibodies}
- C07K 2317/10: characterized by their source of isolation or production
- C07K 2317/20: characterized by taxonomic origin
- 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)
- A23K: FODDER
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- 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

Described herein is secretory IgA isolated from the intestinal luminal fluid and intestinal mucosal of animals such as pigs and cows. Also included are methods of isolating secretory IgA. The secretory IgA is useful in food compositions such as animal and human food compositions as well as pharmaceutical compositions to increase growth rate, improve feed efficiency, reduce gastrointestinal inflammation, reduce a risk of gastrointestinal infection in the animal, or a combination thereof.

## Claims

### Claim 1

A composition comprising
pure, optionally pasteurized secretory IgA isolated from intestinal luminal fluid or intestinal mucosa of a pig or a cow.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the pure secretory IgA is greater than 75% pure.

### Claim 3 (depends on 1)

The composition of claim 1, in the form of a pharmaceutical composition further comprising a pharmaceutically acceptable excipient.

### Claim 4

A composition comprising
secretory IgA isolated from a source that is intestinal mucosa of a pig or a cow, wherein the concentration of secretory IgA in the isolated secretory IgA is at least twice the concentration in the source material, wherein the source material is dried intestinal mucosa, an aqueous preparation from intestinal mucosa, or a dry preparation of proteins prepared from intestinal mucosa.

### Claim 5 (depends on 4)

The composition of claim 4, wherein greater than 5% of the protein in the isolated secretory IgA comprises IgA.

### Claim 6

A food composition comprising
a basal food composition, and
an amount of secretory IgA effective to increase growth rate, improve feed efficiency, reduce gastrointestinal inflammation, reduce a risk of gastrointestinal infection in the animal, or a combination thereof.

### Claim 7 (depends on 6)

The food composition of claim 6, wherein the secretory IgA is in the form of a pure, optionally pasteurized secretory IgA composition isolated from the intestinal luminal fluid or intestinal mucosa of a pig or a cow.

### Claim 8 (depends on 7)

The food composition of claim 7, wherein the food composition is a human food composition.

### Claim 9 (depends on 7)

The food composition of claim 7, wherein the food composition is an animal food composition.

### Claim 10 (depends on 7)

The food composition of claim 7, wherein the pure, pasteurized secretory IgA composition comprises greater than 0.1 mg/Kg food

### Claim 11 (depends on 9)

The food composition of claim 9, wherein the basal animal food composition is for an avian, porcine, bovine, ovine, capra, fish, reptile, mollusk, invertebrate animal, horse, dog, or cat.

### Claim 12 (depends on 9)

The food composition of claim 9, wherein the basal animal food composition is for a chicken and wherein the animal food composition has improved feed efficiency compared to the basal food composition.

### Claim 13 (depends on 9)

The food composition of claim 9, wherein the basal animal food composition is for a pig and wherein the animal food composition has improved feed efficiency compared to the basal food composition.

### Claim 14 (depends on 6)

The food composition of claim 6, wherein the subject is an animal and the secretory IgA is added in the form of dried intestinal mucosa from a pig or a cow, wherein the dried intestinal mucosa is not hydrolyzed.

### Claim 15 (depends on 14)

The food composition of claim 14, comprising 1 mg/Kg to 10 grams/Kg of the dried intestinal mucosa to the basal animal food composition.

### Claim 16 (depends on 14)

The food composition of claim 14, wherein the intestinal mucosa is lyophilized, spray dried, or drum-dried.

### Claim 17 (depends on 14)

The animal food composition of claim 14, wherein the basal food composition is an animal food composition for an avian, porcine, bovine, ovine, capra, fish, reptile, mollusk, invertebrate animal, horse, dog, or cat.

### Claim 18 (depends on 14)

The food composition of claim 14, wherein the basal animal food composition is for a chicken and wherein the animal food composition has improved feed efficiency compared to the basal food composition.

### Claim 19 (depends on 14)

The food composition of claim 14, wherein the basal animal food composition is for a pig and wherein the animal food composition has improved feed efficiency compared to the basal food composition.

### Claim 20

A method of increasing growth rate, improving feed efficiency, reducing gastrointestinal inflammation, reducing a risk of gastrointestinal infection, or a combination thereof in a subject, comprising
administering to the subject an amount of secretory IgA effective to increase growth rate, improve feed efficiency, reduce gastrointestinal inflammation, reduce a risk of gastrointestinal infection, or a combination thereof in the subject.

### Claim 21 (depends on 20)

The method of claim 20, wherein the secretory IgA is in the form of pure, pasteurized secretory IgA isolated from the intestinal luminal fluid or intestinal mucosa of a pig or a cow.

### Claim 22 (depends on 21)

The method of claim 21, wherein the subject is a human.

### Claim 23 (depends on 22)

The method of claim 22, wherein the subject is an animal

### Claim 24 (depends on 23)

The method of claim 23, wherein the animal is an avian, porcine, bovine, ovine, capra, fish, reptile, mollusk, invertebrate animal, horse, dog, or cat.

### Claim 25 (depends on 23)

The method of claim 23, wherein the animal is a chicken and wherein the secretory IgA is administered in the form of an animal food composition comprising the secretory IgA that has improved feed efficiency compared to a basal food composition.

### Claim 26 (depends on 23)

The method of claim 23, wherein the animal is a pig and wherein the secretory IgA is administered in the form of an animal food composition comprising the secretory IgA that has improved feed efficiency compared to a basal food composition.

### Claim 27 (depends on 20)

The method of claim 20, wherein the amount of secretory IgA effective to increase growth rate and/or improve feed efficiency in the animal is added in the form of dried intestinal mucosa from a pig or a cow, wherein the dried intestinal mucosa is not hydrolyzed.

### Claim 28 (depends on 27)

The method of claim 27, wherein the intestinal mucosa is lyophilized, spray dried, or drum-dried.

### Claim 29 (depends on 27)

The method of claim 27, wherein the subject is an animal and wherein the animal is an avian, porcine, bovine, ovine, capra, fish, reptile, mollusk, invertebrate animal, horse, dog, or cat.

### Claim 30 (depends on 29)

The method of claim 29, wherein the animal is a chicken and wherein the secretory IgA is administered in the form of an animal food composition comprising the secretory IgA that has improved feed efficiency compared to a basal food composition.

### Claim 31 (depends on 29)

The method of claim 29, wherein the animal is a pig and wherein the secretory IgA is administered in the form of an animal food composition comprising the secretory IgA that has improved feed efficiency compared to a basal food composition.

### Claim 32

A method of increasing growth rate, improving feed efficiency, reducing gastrointestinal inflammation, reducing a risk of gastrointestinal infection, or a combination thereof in an animal, comprising
administering to the animal dried intestinal mucosa from a pig or a cow, wherein the dried intestinal mucosa is not hydrolyzed, and wherein the dried intestinal mucosa contains an amount of secretory IgA effective to increase growth rate, improve feed efficiency, reduce gastrointestinal inflammation, reduce a risk of gastrointestinal infection, or a combination thereof in the animal.

### Claim 33 (depends on 32)

The method of claim 32, wherein the intestinal mucosa is lyophilized, spray dried, or drum-dried.

### Claim 34 (depends on 32)

The method of claim 32, wherein the animal is an avian, porcine, bovine, ovine, capra, fish, reptile, mollusk, invertebrate animal, horse, dog, or cat.

### Claim 35 (depends on 34)

The method of claim 34, wherein the animal is a chicken, and wherein the dried intestinal mucosa is administered in the form of an animal food composition, wherein the animal food composition comprising the dried intestinal mucosa has improved feed efficiency compared to a basal food composition.

### Claim 36 (depends on 34)

The method of claim 34, wherein the animal is a pig, and wherein the dried intestinal mucosa is administered in the form of an animal food composition, wherein the animal food composition comprising the dried intestinal mucosa has improved feed efficiency compared to a basal food composition.

### Claim 37

A process for purifying secretory IgA, comprising
treating the intestinal luminal fluid of a pig with polyethylene glycol having a molecular weight of 3000 to 30,000 to precipitate the secretory IgA, and
isolating the precipitated secretory IgA.

### Claim 38 (depends on 37)

The method of claim 37, further comprising
resuspending the precipitated secretory IgA is in a solution of polyethylene glycol having a molecular weight of 3000 to 30,000 to produce re-precipitated secretory IgA, and
isolating the re-precipitated secretory IgA.

### Claim 39 (depends on 38)

The method of claim 38, further comprising pasteurizing the pure secretory IgA composition.

### Claim 40 (depends on 39)

The method of claim 39, wherein pasteurization is at a temperature of 50-100° C. for 5-30 seconds.

### Claim 41 (depends on 39)

The method of claim 39, wherein pasteurization is at a temperature of 120-150° C. for 1-8 seconds.

### Claim 42

A method of preparing an animal food, comprising
drying unhydrolyzed pig or cow intestinal mucosa, and
adding the dried, unhydrolyzed pig or cow intestinal mucosa to a basal animal food composition.

### Claim 43 (depends on 42)

The method of claim 42, wherein drying comprises lyophilizing, spray drying or drum drying.

### Claim 44 (depends on 43)

The method of claim 43, wherein the animal is an avian, porcine, bovine, ovine, capra, fish, reptile, mollusk, invertebrate animal, horse, dog, or cat.
