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Last Updated: March 29, 2024

Claims for Patent: 9,260,721


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Summary for Patent: 9,260,721
Title:Expression vector and methods of producing high levels of proteins
Abstract: A process for high expression of protein of interest using an expression vector. The process comprises at least the following regulatory elements: a) a CMV promoter, or a functional variant thereof, b) an intron, c) TPL or a functional variant thereof, d) VA gene or a functional variant thereof, and e) a bovine growth hormone polyadenylation sequence or a functional variant thereof.
Inventor(s): Singh; Arun K. (Gujarat, IN), Goel; Ashish (Gujarat, IN), Mendiratta; Sanjeev K. (Gujarat, IN)
Assignee: Cadila Healthcare Limited (Ahmedabad, IN)
Application Number:13/471,501
Patent Claims:1. A mammalian expression vector which consists of: a) a CMV promoter, or a functional variant thereof, b) a chimeric intron having the nucleic acid sequence of SEQ ID NO: 1, c) tripartite leader element (TPL) or a functional variant thereof, d) a viral associated (VA) RNA gene or a functional variant thereof, and e) a bovine growth hormone polyadenylation sequence or a functional variant thereof; and f) a nucleic acid sequence encoding a protein of interest.

2. The vector as claimed in claim 1, wherein the TPL is a TPL having the nucleic acid sequence of SEQ ID NO: 4.

3. The vector as claimed in claim 1, wherein the VA gene or functional variant thereof has the nucleic acid sequence genes are having a sequence of SEQ ID NO: 5.

4. The vector as claimed in claim 1, further comprising a selection and amplification marker selected from the group consisting of dihydrofolate reductase, adenosine deaminase, ornithine decarboxylase, asparagine synthetase, and glutamine synthetase, or a functional variant thereof.

5. The vector as claimed in claim 1, encoding the gene for erythropoietin.

6. The vector as claimed in claim 1, encoding the gene for fusion protein, TNFR-IgGFc.

7. The vector as claimed in claim 1, encoding a gene for rituximab, trastuzumab, bevacuzumab or other monoclonal antibodies.

8. The vector as claimed in claim 1, encoding one of more genes capable of expression in a mammalian cell.

9. A mammalian cell transformed with an expression vector as claimed in claim 1.

10. The mammalian cell as claimed in claim 9 wherein the mammalian cell is selected from the group consisting of Cos, CHO, CHO DHFR-, BHK1, and NS0.

11. A mammalian expression vector consisting of: a) a CMV promoter, or a functional variant thereof, b) a chimeric intron having the nucleic acid sequence of SEQ ID NO: 1, c) a tripartite leader element (TPL) having the nucleic acid sequence of SEQ ID NO: 4 or a functional variant thereof, d) a viral associated (VA) VA genes an RNA gene having the nucleic acid sequence of SEQ ID NO: 5 or a functional variant thereof, e) a bovine growth hormone polyadenylation sequence or a functional variant thereof; and f) a nucleic acid sequence encoding a protein of interest.

12. The vector as claimed in claim 11, encoding the gene for erythropoietin.

13. The vector as claimed in claim 11, encoding the gene for fusion protein, TNFR-IgGFc.

14. The vector as claimed in claim 11, further comprising a selection and amplification marker selected from the group consisting of dihydrofolate reductase, adenosine deaminase, ornithine decarboxylase, asparagine synthetase, and glutamine synthetase, or a functional variant thereof.

Details for Patent 9,260,721

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b For Injection 103132 06/04/1986 ⤷  Try a Trial 2025-06-20
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b For Injection 103132 ⤷  Try a Trial 2025-06-20
Merck Sharp & Dohme Corp. INTRON A interferon alfa-2b Injection 103132 ⤷  Try a Trial 2025-06-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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