# US 2022/0033487 A1 · Methods of Producing Ustekinumab

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- Number: US 2022/0033487 A1
- Document ID: US20220033487A1
- Status: Published application
- Kind: A1
- Application number: 17/419,480
- Filed: 2019-12-20
- Published: 2022-02-03
- Earliest claimed: 2018-12-31
- Assignees: Momenta Pharmaceuticals, Inc.
- Applicants: Momenta Pharmaceuticals, Inc.
- Inventors: Ru Zang
- Web page: https://patentgrep.com/patent/US20220033487A1

## CPC

- C07K 16/244: {Interleukins [IL]}
- C07K 2317/14: Specific host cells or culture conditions, e.g. components, pH or temperature
- C07K 2317/21: from primates, e.g. man
- C07K 2317/31: multispecific
- C07K 2317/41: Glycosylation, sialylation, or fucosylation
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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)

## Abstract

Methods of manufacturing an ustekinumab product with a target level of one or more glycans are described.

## Claims

### Claim 1

A method of manufacturing a pharmaceutical composition comprising ustekinumab having a target level of G0F glycan, the method comprising:
(a) selecting a target level of G0F glycan,
(b) selecting a level of galactose and a time for cell culture to provide the selected level of G0F glycan, wherein the level of galactose and the time are inversely related;
(c) culturing a population of cells genetically engineered to express ustekinumab under conditions comprising the selected level of galactose and time;
(d) harvesting ustekinumab expressed by the population of cells, thereby producing the preparation of ustekinumab; and
(e) purifying, concentrating, and/or formulating the ustekinumab preparation to produce pharmaceutical composition comprising ustekinumab if the preparation meets the target level of G0F glycan.

### Claim 2 (depends on 1)

The method of claim 1, wherein the culturing is performed using a perfusion culture process.

### Claim 3 (depends on 1)

The method of claim 1, wherein the target level of G0F glycan is within a range of 20% to 80% G0F relative to total glycan.

### Claim 4 (depends on 3)

The method of claim 3, wherein the target level of G0F glycan is within a range of 25% to 65% G0F relative to total glycan.

### Claim 5 (depends on 1)

The method of claim 1, wherein the target level of G0F glycan is within a range of 20% up to 40% G0F relative to total glycan, wherein the selected level of galactose is 0 mM, and wherein the time for cell culture is within a range of 7 days to 15 days.

### Claim 6 (depends on 1)

The method of claim 1, wherein the target level of G0F glycan is within a range of 40% to 80% G0F relative to total glycan, wherein the selected level of galactose is within a range of 15 mM to 30 mM, and wherein the time for cell culture is within a range of 16 days to 60 days.

### Claim 7 (depends on 6)

The method of claim 6, wherein the time for cell culture is within a range of 25 days to 42 days.

### Claim 8 (depends on 1)

The method of claim 1, further comprising measuring a level of G0F glycan.

### Claim 9 (depends on 1)

The method of claim 1, wherein the population of cells genetically engineered to express ustekinumab are mammalian cells.

### Claim 10 (depends on 9)

The method of claim 9, wherein the mammalian cells are selected from CHO cells, HEK 293 cells, fibrosarcoma HT 1080 cells, PER.C6 cells, CAP cells, HKB-11 cells, HuH-7 cells, NS0 cells and SP 2/0 cells.

### Claim 11 (depends on 1)

The method of claim 1, wherein the selected level of galactose controlled during culturing from t=0 until harvest.

### Claim 12 (depends on 1)

The method of claim 1, wherein the ustekinumab expressed by the cells is harvested at two or more times within the range of time of the time for cell culture.