# US 2020/0216799 A1 · Methods for viral inactivation and other adventitious agents

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- Number: US 2020/0216799 A1
- Document ID: US20200216799A1
- Status: Published application
- Kind: A1
- Application number: 16/515,929
- Filed: 2019-07-18
- Published: 2020-07-09
- Earliest claimed: 2012-06-20
- Assignees: Genentech, Inc.
- Applicants: Genentech, Inc.
- Inventors: Masaru Ken SHIRATORI; Robert David KISS; Hardayal PRASHAD; Raquel IVERSON; Justin BOURRET; Michael KIM; Salim CHARANIYA
- Web page: https://patentgrep.com/patent/US20200216799A1

## CPC

- C12N 1/36: Adaptation or attenuation of cells
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12N 2750/14061: Methods of inactivation or attenuation
- C12N 2760/12061: Methods of inactivation or attenuation
- C12N 2760/16061: Methods of inactivation or attenuation
- C12N 2760/18061: Methods of inactivation or attenuation
- C12N 2760/20061: Methods of inactivation or attenuation
- C12N 2770/16061: Methods of inactivation or attenuation
- C12N 2770/32061: Methods of inactivation or attenuation
- C12N 2770/36061: Methods of inactivation or attenuation
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The invention provides for methods of viral inactivation using high temperature short time (HTST) treatment and adjustment of various parameters such that generation of precipitate and depositions of precipitate are reduced and/or minimized.

## Claims

### Claim 1

A method for inactivating virus or adventitious agents in cell culture media while the media maintains suitability for cell culture, said method comprising (a) subjecting the cell culture media to high temperature short time (HTST) treatment; and (b) adjusting one or more parameters selected from the group consisting of pH, calcium level and phosphate level.

### Claim 2 (depends on 1)

The method of claim 1 further comprising adjusting trace metal concentrations.

### Claim 3 (depends on 2)

The method of claim 2 wherein the trace metals is selected from the group consisting of iron and copper.

### Claim 4 (depends on 3)

The method of claim 3 wherein iron and/or copper concentrations are adjusted in the media prior to HTST treatment.

### Claim 5 (depends on 4)

The method of claim 4 wherein iron and/or copper is removed from the media prior to HTST treatment.

### Claim 6 (depends on 4)

The method of claim 4 further comprising supplementing iron and/or copper to the media following HTST treatment to a suitable level for cell culture.

### Claim 7 (depends on 1)

The method of claim 1 wherein the pH is adjusted when the media comprises calcium and phosphate.

### Claim 8 (depends on 7)

The method of claim 7, wherein the pH is adjusted in preparing the media prior to HTST treatment to a suitable low level.

### Claim 9 (depends on 7)

The method of claim 7, wherein the pH is adjusted by lowering to a suitable level.

### Claim 10 (depends on 7)

The method of claim 7, wherein the pH is adjusted to less than about 7.2.

### Claim 11 (depends on 7)

The method of claim 7, wherein the pH is adjusted to about 5.0-7.2.

### Claim 12 (depends on 7)

The method of claim 7, further comprising adjusting the pH following HTST treatment to a suitable level for cell culture.

### Claim 13 (depends on 12)

The method of claim 12, wherein the pH is adjusted to about 6.9-7.2.

### Claim 14 (depends on 1)

The method of claim 1, wherein the calcium level is adjusted when the media comprises phosphate.

### Claim 15 (depends on 14)

The method of claim 14, wherein the calcium level is reduced.

### Claim 16 (depends on 15)

The method of claim 15 wherein the calcium level is reduced such that formation of complexes comprised of calcium and phosphate is suppressed.

### Claim 17 (depends on 15)

The method of claim 15, wherein calcium is removed from the media prior to HTST treatment.

### Claim 18 (depends on 15)

The method of claim 15, wherein the pH is adjusted such that formation of complexes comprised of calcium and phosphate is suppressed.

### Claim 19 (depends on 14)

The method of claim 14 further comprising adjusting the calcium level following HTST treatment to a suitable level for cell culture.

### Claim 20 (depends on 1)

The method of claim 1, wherein the phosphate level is adjusted when the media comprises calcium.

### Claim at position 21

21-38. (canceled)