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Last Updated: March 28, 2024

Claims for Patent: 9,957,541


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Summary for Patent: 9,957,541
Title:Cell expression system
Abstract: An expression system for expressing a protein comprising: a eukaryotic host cell carrying a dihydrofolate reductase (DHFR) deficiency; and an expression vector, the expression vector encoding the human growth hormone gene; a expression vector, the expression vector comprising: a eukaryotic selectable marker including a minimal SV 40 early promoter driving expression of a sequence encoding dihydrofolate reductase for complementing the DHFR deficiency in the host cell; a prokaryotic selectable marker conveying Ampicillin resistance to a prokaryotic host cell; a prokaryotic Origin of Replication; a plurality of multiple cloning sites (MCS); and at least one protein expression module comprising: a Simian Vacuolating Virus 40 (SV40) early promoter, inclusive of its 72 bp enhancer repeats; and a rabbit .beta.-globin intron sequence being separable from a SV40 p A sequence by a first multiple cloning site, for receiving a coding sequence and expressing a desired protein therefrom.
Inventor(s): Sunstrom; Noelle (Eveleigh, AU)
Assignee: NeuClone Biologics Pty Ltd (Eveleigh, NSW, AU)
Application Number:15/148,930
Patent Claims:1. A method for producing a desired recombinant polypeptide comprising culturing a mammalian host cell expressing a desired recombinant polypeptide in a cell culture media comprising a human Growth Hormone (hGH) or modified hGH, wherein the hGH or modified hGH is added to the cell culture media and enhances survival and/or cell density and/or cell viability of the mammalian host cell expressing the desired recombinant polypeptide.

2. The method according to claim 1, wherein the mammalian host cell is a CHO cell.

3. The method according to claim 2, wherein the CHO cell is selected from the group consisting of: a CHO-K1, a CHO-DG44 and a CHO-S cell.

4. The method according to claim 2, wherein the CHO cell has a dihydrofolate reductase (DHFR) deficiency.

5. The method according to claim 1, wherein culturing is performed in a suspension culture.

6. The method according to claim 1, wherein culturing is performed in an adherent culture.

7. The method according to claim 1, wherein the desired recombinant polypeptide is a biosimilar of a recombinant protein.

8. The method according to claim 7, wherein the recombinant protein is selected from the group consisting of: Infliximab, Adalimumab, Etanercept, Rituximab, Bevacizumab, Trastuzumab, Ranibizumab, Cetuximab, Erythropoietin alpha, Interferon alpha, Interferon alpha 2a and Interferon alpha 2b.

9. The method according to claim 1, wherein the addition of the hGH or modified hGH to the cell culture media increases cell density and viability of the host mammalian cell compared to a mammalian cell of the same cell type as the host mammalian cell supplemented with insulin-like growth factor 1 (IGF-1).

Details for Patent 9,957,541

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2033-08-03
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2033-08-03
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 09/25/1998 ⤷  Try a Trial 2033-08-03
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 02/10/2017 ⤷  Try a Trial 2033-08-03
Immunex Corporation ENBREL etanercept For Injection 103795 11/02/1998 ⤷  Try a Trial 2033-08-03
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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