# US 2023/0272000 A1 · Saponin purification

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- Number: US 2023/0272000 A1
- Document ID: US20230272000A1
- Status: Published application
- Kind: A1
- Application number: 18/098,949
- Filed: 2023-01-19
- Published: 2023-08-31
- Earliest claimed: 2017-12-01
- Assignees: Glaxosmithkline Biologicals SA
- Applicants: Glaxosmithkline Biologicals SA
- Inventors: Ahmad Taimour BAIG; Felicie Georgette, Colette DENET; Juan Jose DIAZ GARCIA; Chad Austin FARRENBURG; Lora Lea LAWRENCE; Kent Raymond MYERS; Jeri Kay SANDVICK; Jeb Yeatts VANDENBURG
- Web page: https://patentgrep.com/patent/US20230272000A1

## CPC

- C07J 63/008: {Expansion of ring D by one atom, e.g. D homo steroids}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 39/12: Viral antigens
- A61K 39/25: Varicella-zoster virus
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- 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 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- A61K 2039/55577: {Saponins; Quil A; QS21; ISCOMS}
- C12N 2710/16734: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/18534: 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
- C07J: STEROIDS (seco-steroids C07C)
- 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

Saponin extracts containing at least 93% QS-21 main peak and 0.25-3% 2018 component by UV absorbance at 214 nm, methods for making said extracts, their use as vaccine adjuvants and related aspects.

## Claims

### Claim at position 1

1-79. (canceled)

### Claim 80

An adjuvant composition comprising a liposomal formulation comprising a saponin extract; the saponin extract comprising at least 93%, in sum and as determined by UV absorbance at 214 nm, of one or more of:
and 0.25-3%, as determined by UV absorbance at 214 nm, of:

### Claim 81

An adjuvant composition comprising a toll-like receptor-4 (TLR4) agonist and a saponin extract; the saponin extract comprising at least 93%, in sum and as determined by UV absorbance at 214 nm, of one or more of:
and 0.25-3%, as determined by UV absorbance at 214 nm, of:

### Claim 82 (depends on 81)

The adjuvant composition according to claim 81, wherein the TLR4 agonist is 3D-MPL.

### Claim 83

An immunogenic composition comprising:
a) an adjuvant composition comprising a saponin extract comprising at least 93%, in sum and as determined by UV absorbance at 214 nm, of one or more of:
and 0.25-3%, as determined by UV absorbance at 214 nm, of:
and
b) an immunogen or an antigen, or a polynucleotide encoding the immunogen or the antigen.

### Claim 84 (depends on 83)

The immunogenic composition according to claim 83 comprising the antigen; wherein the antigen is derived from Varicella zoster virus.

### Claim 85 (depends on 83)

The immunogenic composition according to claim 83 comprising the antigen; wherein the antigen is derived from human respiratory syncytial virus.

### Claim 86 (depends on 80)

The adjuvant composition according to claim 80, wherein the saponin extract comprises at least 98%, in sum and as determined by UV absorbance at 214 nm, of one or more of:
and 2118 component.

### Claim 87 (depends on 80)

The adjuvant composition according to claim 80, wherein the saponin extract comprises at least 65%, in sum and as determined by UV absorbance at 214 nm and by relative ion abundance, of one or both of:

### Claim 88 (depends on 80)

The adjuvant composition according to claim 80, wherein the saponin extract comprises at least 5% of:
by UV absorbance at 214 nm and by relative ion abundance.

### Claim 89 (depends on 80)

The adjuvant composition according to claim 80, wherein the saponin extract comprises at least 0.5% of:
by UV absorbance at 214 nm and by relative ion abundance.

### Claim 90 (depends on 80)

The adjuvant composition according to claim 80, wherein the saponin extract comprises at least 1% of:
by UV absorbance at 214 nm.

### Claim 91 (depends on 81)

The adjuvant composition according to claim 81, wherein the saponin extract comprises at least 98%, in sum and by UV absorbance at 214 nm, of one or more of:
and 2118 component.

### Claim 92 (depends on 81)

The adjuvant composition according to claim 81, wherein the saponin extract comprises at least 65%, in sum and by UV absorbance at 214 nm and by relative ion abundance, of one or both of:

### Claim 93 (depends on 81)

The adjuvant composition according to claim 81, wherein the saponin extract comprises at least 5% of:
by UV absorbance at 214 nm and by relative ion abundance.

### Claim 94 (depends on 81)

The adjuvant composition according to claim 81, wherein the saponin extract comprises at least 0.5% of:
by UV absorbance at 214 nm and by relative ion abundance.

### Claim 95 (depends on 81)

The adjuvant composition according to claim 81, wherein the saponin extract comprises at least 1% of:
by UV absorbance at 214 nm.

### Claim 96 (depends on 83)

The immunogenic composition according to claim 83, wherein the saponin extract comprises at least 98%, in sum and by UV absorbance at 214 nm, of one or more of:
and 2118 component.

### Claim 97 (depends on 83)

The immunogenic composition according to claim 83, wherein the saponin extract comprises at least 65%, in sum and by UV absorbance at 214 nm and by relative ion abundance, of one or both of:

### Claim 98 (depends on 83)

The immunogenic composition according to claim 83, wherein the saponin extract comprises at least 5% of:
by UV absorbance at 214 nm and by relative ion abundance.

### Claim 99 (depends on 83)

The immunogenic composition according to claim 83, wherein the saponin extract comprises at least 0.5% of:
by UV absorbance at 214 nm and by relative ion abundance.

### Claim 100 (depends on 83)

The immunogenic composition according to claim 83, wherein the saponin extract comprises at least 1% of:
by UV absorbance at 214 nm.