Low acidic species compositions and methods for producing and using the same using displacement chromatography
US-9017687-B1 · Apr 28, 2015 · US
Methods to modulate lysine variant distribution
US9181572B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9181572-B2 |
| Application number | US-201313830976-A |
| Country | US |
| Kind code | B2 |
| Filing date | Mar 14, 2013 |
| Priority date | Apr 20, 2012 |
| Publication date | Nov 10, 2015 |
| Grant date | Nov 10, 2015 |
How to read this patent
A practical reading order for non-experts. Skip the full description unless you need deep technical detail.
- Title
What the patent document calls the invention.
- Abstract
A short plain-language summary of the technical disclosure.
- Assignees and inventors
Who owns or filed the patent and who is credited as inventor.
- Key dates
Filing, priority, publication, and grant dates set the timeline.
- First independent claim
The legal scope of protection — read this for what is actually claimed.
- CPC / IPC classifications
Technology tags used to group this patent with similar filings.
- Citations and related patents
Prior art links and similar publications in this corpus.
Abstract
Official abstract text for this publication.
The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the distribution or amount of lysine variants expressed by host cells, as well as to compositions and processes for controlling the amount of lysine variants present in purified preparations.
First claim
Opening claim text (preview).
What is claimed is: 1. A method for producing a composition comprising adalimumab, comprising culturing a cell producing adalimumab in a cell culture media comprising an amount of one or more basic amino acids sufficient to produce a composition comprising adalimumab in which less than 62% of the lysine variant species of adalimumab have zero C-terminal lysines (Lys 0). 2. The method of claim 1 , wherein the one or more basic amino acids in the cell culture media is selected from the group consisting of arginine, lysine, histidine, ornithine and combinations thereof. 3. The method of claim 2 , wherein the one or more basic amino acids in the cell culture media is ornithine. 4. The method of claim 2 , wherein the one or more basic amino acids in the cell culture media is lysine. 5. The method of claim 4 , wherein the lysine concentration in the cell culture media is 4 to 10 g/L. 6. The method of claim 2 , wherein the one or more basic amino acids in the cell culture media is histidine. 7. The method of claim 1 , wherein 61% or less of the lysine variant species have zero C-terminal lysines (Lys 0). 8. The method of claim 1 , wherein 60% or less of the lysine variant species have zero C-terminal lysines (Lys 0). 9. The method of claim 1 , wherein 58% or less of the lysine variant species have zero C-terminal lysines (Lys 0). 10. The method of claim 1 , wherein 55% or less of the lysine variant species have zero C-terminal lysines (Lys 0). 11. The method of claim 1 , wherein 48% or less of the lysine variant species have zero C-terminal lysines (Lys 0). 12. The method of claim 2 , wherein the one or more basic amino acids in the cell culture media is arginine. 13. The method of claim 12 , wherein the arginine concentration in the cell culture media is 6 to 9 g/L. 14. The method of claim 6 , wherein the histidine concentration in the cell culture media is 8 g/L or more. 15. The method of claim 12 , wherein the arginine concentration in the cell culture media is 6 g/L or more. 16. The method of claim 12 , wherein the arginine concentration in the cell culture media is 8 g/L or more. 17. The method of claim 12 , wherein the arginine concentration in the cell culture media is 9 g/L or more. 18. The method of claim 4 , wherein the lysine concentration in the cell culture media is 4 g/L or more. 19. The method of claim 4 , wherein the lysine concentration in the cell culture media is 8 g/L or more. 20. The method of claim 4 , wherein the lysine concentration in the cell culture media is 10 g/L or more. 21. A method for producing a composition comprising adalimumab, comprising culturing a cell producing adalimumab in a cell culture media comprising an amount of lysine sufficient to produce a composition comprising adalimumab in which less than 62% of the lysine variant species of adalimumab have zero C-terminal lysines (Lys 0). 22. The method of claim 21 , wherein the lysine concentration in the cell culture media is 4 to 10 g/L. 23. The method of claim 21 , wherein the lysine concentration in the cell culture media is 4 g/L or more. 24. The method of claim 21 , wherein the lysine concentration in the cell culture media is 8 g/L or more. 25. The method of claim 21 , wherein the lysine concentration in the cell culture media is 10 g/L or more. 26. The method of claim 21 , wherein 61% or less of the lysine variant species have zero C-terminal lysines (Lys 0). 27. The method of claim 21 , wherein 55% or less of the lysine variant species have zero C-terminal lysines (Lys 0). 28. The method of claim 21 , wherein 48% or less of the lysine variant species have zero C-terminal lysines (Lys 0). 29. A method for producing a composition comprising adalimumab, comprising culturing a cell producing adalimumab in a cell culture media comprising an amount of one or more basic amino acids sufficient to produce a composition comprising adalimumab wherein the sum of lysine variant species of adalimumab having one C-terminal lysine (Lys 1) and lysine variant species of adalimumab having two C-terminal lysines (Lys 2) is greater than 35%. 30. The method of claim 29 , wherein the one or more basic amino acids in the cell culture media is selected from the group consisting of arginine, lysine, histidine, ornithine and combinations thereof.
Assignees
Inventors
Classifications
- C07K16/241Primary
Tumor Necrosis Factors · CPC title
Zinc; Zn chelators · CPC title
Cells for large scale production · CPC title
characterized by post-translational modification · CPC title
Specific host cells or culture conditions, e.g. components, pH or temperature · CPC title
Patent family
Related publications grouped by family.
External sources
Frequently asked questions
Answers are generated from the same data shown on this page.
- What does patent US9181572B2 cover?
- The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the distribution or amount of lysine variants expressed by host cells, as well as to compositions and processes for controlling the amount of lysine variants present in purified preparations.
- Who is the assignee on this patent?
- Abbvie Inc, Abbvie Inc
- What technology area does this patent fall under?
- Primary CPC classification C07K16/241. Mapped technology areas include Chemistry & Metallurgy.
- When was this patent published?
- Publication date Tue Nov 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time) (B2). Legal status and post-grant events are not shown on this page.
- What related patents are in patentsdb?
- We list 6 related publications on this page (citations in our corpus or others sharing the same primary CPC).