# US 2014/0371431 A1 · PROCESS FOR PREPARATION OF SECRETORY IgA AND SECRETORY IgM

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- Number: US 2014/0371431 A1
- Document ID: US20140371431A1
- Status: Published application
- Kind: A1
- Application number: 14/476,559
- Filed: 2014-09-03
- Published: 2014-12-18
- Earliest claimed: 2012-03-09
- Inventors: Stephen C. Brown; Michael R. Simon; Blaise Corthésy
- Web page: https://patentgrep.com/patent/US20140371431A1

## CPC

- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- B01D 15/3804: {Affinity chromatography}
- C07K 14/70535: {Fc-receptors, e.g. CD16, CD32, CD64 (CD2314/705F)}
- C07K 16/065: {Purification, fragmentation}
- C07K 16/18: against material from animals or humans
- A61K 2039/505: {comprising antibodies}
- C07K 1/14: Extraction; Separation; Purification
- C07K 2317/21: from primates, e.g. man
- C07K 2319/036: targeting to the medium outside of the cell, e.g. type III secretion
- C07K 2319/10: containing a tag for extracellular membrane crossing, e.g. TAT or VP22
- C07K 2319/32: fusions with soluble part of a cell surface receptor, "decoy receptors"
- 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
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- 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

A process for synthesizing and separating secretory IgA from a mixture of IgA monomer and IgA dimer is provided. The process includes covalently binding affinity tagged or epitope tagged recombinant secretory component to the IgA dimer in the mixture and binding the affinity tagged or an epitope tagged secretory IgA to immobilized moieties on the solid phase support resin to which the affinity tag or epitope tag binds and then eluting the affinity tagged or an epitope tagged secretory IgA with release buffer. A process for synthesizing and separating secretory IgM from a mixture of IgM and other plasma proteins is also provided. The process includes covalently binding affinity tagged or an epitope tagged recombinant secretory component to the IgM in the mixture and binding the affinity tagged or an epitope tagged secretory IgM to immobilized moieties on the solid phase support resin and then eluting the peptide tagged secretory IgM with a release buffer.

## Claims

### Claim 1

A process for synthesizing and separating an immunoglobulin of secretory IgA from an a monomer and dimer mixture of either IgA mixed with other proteins comprising:
adding secretory component tagged with an affinity tag to the protein mixture containing IgA dimers, facilitating the covalent binding of the affinity tagged secretory component to the IgA dimer;
recovering the secretory IgA by adhesion of the affinity tagged secretory IgA to immobilized moieties on the solid phase support resin to which the affinity tag or epitope tag binds; and
eluting the bound secretory IgA with a release buffer.

### Claim 2 (depends on 1)

The process of claim 1 wherein the secretory component is human.

### Claim 3 (depends on 1)

The process of claim 1 wherein the monomer and dimer mixture is obtained from human plasma.

### Claim 4 (depends on 1)

The process of claim 1 wherein the peptide tag is removed from the secretory IgA.

### Claim 5 (depends on 1)

The process of claim 1 wherein the peptide tag is histidine or polyhistidine.

### Claim 6 (depends on 1)

The process of claim 1 wherein the moiety on the solid phase support resin to which the peptide binds is a divalent cation.

### Claim 7 (depends on 1)

The process of claim 1 further comprising washing the unbound IgA monomer through the resin prior to the eluting the secretory IgA.

### Claim 8 (depends on 1)

The process of claim 1 wherein the secretory component is recombinant.

### Claim 9 (depends on 8)

The process of claim 8 wherein the secretory component is expressed with said histidine or polyhistidine.

### Claim 10 (depends on 1)

The process of claim 1 further comprising coupling said histidine or polyhistidine to the secretory component in vitro.

### Claim 11

A composition comprising:
a dimeric IgA;
secretory component bonded to said dimeric IgA; and
a histidine or polyhistidine covalently bonded to said secretory component.

### Claim 12

A process for synthesizing and separating a secretory IgM immunoglobulin from pentameric IgM mixed with other proteins comprising:
adding secretory component tagged with an epitope tag to the protein mixture containing IgM pentamers, facilitating the covalent binding of the epitope tagged secretory component to the IgM pentamer;
recovering the secretory IgM by adhesion of the epitope tagged secretory IgM to immobilized moieties on the solid phase support resin to which the affinity tag or epitope tag binds; and
eluting the bound secretory IgM with a release buffer.

### Claim 13 (depends on 12)

The process of claim 12 wherein the secretory component is human.

### Claim 14 (depends on 12)

The process of claim 12 wherein the mixture is obtained from human plasma.

### Claim 15 (depends on 12)

The process of claim 12 wherein the epitope tag is removed from secretory IgM.

### Claim 16 (depends on 12)

The process of claim 12 wherein the moiety on the solid phase support resin to which the epitope tag binds is a divalent cation.

### Claim 17 (depends on 12)

The process of claim 12 further comprising washing the unbound IgM monomer through the resin prior to the eluting the secretory IgM.

### Claim 18 (depends on 12)

The process of claim 12 wherein the secretory component is recombinant.

### Claim 19 (depends on 12)

The process of claim 12 further comprising coupling said histidine or polyhistidine to the secretory component in vitro.

### Claim 20

A composition comprising:
a pentameric IgM;
secretory component bonded to said pentameric IgM; and
a histidine or polyhistidine covalently bonded to said secretory component.
