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Last Updated: April 19, 2024

Claims for Patent: 9,404,078

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Summary for Patent: 9,404,078

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:	14/773,287
Patent Claims:	1. A method for producing a desired recombinant polypeptide comprising culturing a mammalian host cell expressing a desired recombinant polypeptide in the presence of a human Growth Hormone (hGH) or modified hGH, wherein the mammalian host cell co-expresses the hGH or modified hGH and the desired recombinant polypeptide, and wherein expression of the hGH or modified hGH 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 hGH is constitutively expressed in the mammalian host cell. 3. The method according to claim 1, wherein the mammalian host cell is a CHO cell. 4. The method according to claim 3, wherein the CHO cell is selected from the group consisting of: a CHO-K1, a CHO-DG44 and a CHO-S cell. 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 expression of the hGH or modified hGH increase cell density and viability of the host mammalian cell compared to the mammalian cell supplemented with insulin-like growth factor 1 (IGF-1). 10. A recombinant mammalian host cell for producing a desired recombinant polypeptide, wherein a mammalian host cell co-expresses: i) a human Growth Hormone (hGH) or modified hGH, and ii) a desired recombinant polypeptide, wherein expression of the hGH or modified hGH enhances survival of the mammalian host cell and wherein the desired recombinant polypeptide 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. 11. The recombinant mammalian host cell according to claim 10 wherein the hGH is constitutively expressed in the mammalian host cell. 12. The recombinant mammalian host cell according to claim 10, wherein the mammalian host cell is a CHO cell. 13. An expression system for producing a desired recombinant polypeptide comprising: an expression vector comprising a nucleotide sequence encoding a human Growth Hormone (hGH) or modified hGH; an expression vector comprising a nucleotide sequence encoding a desired recombinant polypeptide; and a mammalian host cell used to co-express the hGH or modified hGH and the desired recombinant polypeptide. 14. The expression system according to claim 13, wherein the mammalian host cell is a CHO cell. 15. The expression system according to claim 14, wherein the CHO cell is selected from the group consisting of: a CHO-K1, a CHO-DG44 and a CHO-S cell. 16. The expression system according to claim 15, wherein the CHO cell has a dihydrofolate reductase (DHFR) deficiency. 17. The expression system according to claim 13, wherein the desired recombinant polypeptide is a biosimilar of a recombinant protein. 18. The expression system according to claim 17, 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. 19. The expression system of claim 17, wherein the recombinant protein is selected from the group consisting of: an antibody that binds tumour necrosis factor, an antibody that binds to a vascular endothelial growth factor, an antibody that binds to HER2, and an antibody that binds to an epidermal growth factor receptor.

Details for Patent 9,404,078

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997	⤷ Try a Trial	2033-03-08
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002	⤷ Try a Trial	2033-03-08
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998	⤷ Try a Trial	2033-03-08
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998	⤷ Try a Trial	2033-03-08
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017	⤷ Try a Trial	2033-03-08
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998	⤷ Try a Trial	2033-03-08
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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