Claims for Patent: 9,914,951
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Summary for Patent: 9,914,951
Title: | Cell culture process |
Abstract: | Polypeptides having target levels of C-terminal variants are described. |
Inventor(s): | Prentice; Holly (Carlisle, MA) |
Assignee: | Momenta Pharmaceuticals, Inc. (Cambridge, MA) |
Application Number: | 15/261,270 |
Patent Claims: | 1. A method of manufacturing a preparation of adalimumab, comprising: culturing a cell in a medium comprising 1.5 g/L lysine to 20 g/L lysine under conditions in which
the cell expresses adalimumab; isolating the adalimumab, thereby producing a preparation of adalimumab; and formulating the preparation into a drug product if the preparation meets a target value of one or more C-terminal variants of adalimumab,
wherein the C-terminal variants differ in amino acid sequence only by the presence or absence of a lysine at their carboxyl termini, wherein the C-terminal variants comprise one or more of a K1 lysine variant and a K2 lysine variant, wherein the K1
lysine variant has a lysine residue at one heavy chain C-terminus and wherein the K2 lysine variant has a lysine residue at each heavy chain C-terminus, and wherein (i) the target value of K1 lysine variants is 10% to 50% of the adalimumab preparation,
or (ii) the target value of K2 lysine variants is 4% to 50% of the adalimumab preparation, or both (i) and (ii).
2. The method of claim 1, wherein the medium comprises 4 g/L lysine to 12 g/L lysine. 3. The method of claim 1, wherein the method further comprises measuring a level of one or more C-terminal variants of adalimumab in the preparation. 4. The method of claim 1, wherein the target value of K1 lysine variants of adalimumab is 12% to 25% of the adalimumab in the preparation. 5. The method of claim 1, wherein the target value of K2 lysine variants of adalimumab is 4% to 6% of the adalimumab in the preparation. 6. The method of claim 1, wherein the cell is a CHO cell. 7. The method of claim 1, wherein the medium has a pH of 6.8 to 7.0. 8. The method of claim 1, wherein the cell is cultured at a temperature of 34.degree. C. to 37.degree. C. 9. A method of manufacturing a preparation of adalimumab, comprising: culturing a cell in a medium comprising 2 g/L lysine to 8 g/L lysine under conditions in which the cell expresses adalimumab; isolating the adalimumab, thereby producing a preparation of adalimumab; and formulating the preparation into a drug product if the preparation meets a target value of one or more C-terminal variants of adalimumab, wherein the C-terminal variants differ in amino acid sequence only by the presence or absence of a lysine at their carboxyl termini, wherein the C-terminal variants comprise one or more of a K1 lysine variant and a K2 lysine variant, wherein the K1 lysine variant has a lysine residue at one heavy chain C-terminus and wherein the K2 lysine variant has a lysine residue at each heavy chain C-terminus, and wherein (i) the target value of K1 lysine variants is 10% to 50% of the adalimumab preparation, or (ii) the target value of K2 lysine variants is 4% to 50% of the adalimumab preparation, or both (i) and (ii). 10. The method of claim 9, wherein the medium comprises 4 g/L lysine to 6 g/L lysine. 11. The method of claim 9, wherein the method further comprises measuring a level of one or more C-terminal variants of adalimumab in the preparation. 12. The method of claim 9, wherein the target value of K1 lysine variants of adalimumab is 12% to 25% of the adalimumab in the preparation. 13. The method of claim 9, wherein the target value of K2 lysine variants of adalimumab is 4% to 6% of the adalimumab in the preparation. 14. The method of claim 9, wherein the cell is a CHO cell. 15. The method of claim 9, wherein the medium has a pH of 6.8 to 7.0. 16. The method of claim 9, wherein the cell is cultured at a temperature of 34.degree. C. to 37.degree. C. |
Details for Patent 9,914,951
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | 12/31/2002 | ⤷ Try a Trial | 2031-07-08 |
Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | 02/21/2008 | ⤷ Try a Trial | 2031-07-08 |
Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | 04/24/2013 | ⤷ Try a Trial | 2031-07-08 |
Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | 09/23/2014 | ⤷ Try a Trial | 2031-07-08 |
Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | 11/23/2015 | ⤷ Try a Trial | 2031-07-08 |
Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | 03/09/2016 | ⤷ Try a Trial | 2031-07-08 |
Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | 10/17/2016 | ⤷ Try a Trial | 2031-07-08 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
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