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Last Updated: April 24, 2024

Claims for Patent: 9,512,200

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Summary for Patent: 9,512,200

Title:	Personalized production of biologics and method for reprogramming somatic cells
Abstract:	The invention provides a method for producing polypeptide protein products and nucleic acid products having reduced levels of antigenicity in an animal being treated with a biologic product. Somatic cells are isolated from an animal, transformed into pluripotent stem cells, transfected with a nucleic acid(s) of interest, and re-differentiated towards somatic cells known to be high level producers of the desired nucleic acid product. The invention can be used to derive a general cell line to treat populations, racial specific cell lines to treat ethnic groups, or patient specific cell lines to treat individuals. Additionally, the invention provides a method to allow induced pluripotent stem cells to be re-differentiated towards their somatic cell of origin so that the cells can be used to therapeutically treat an animal without resulting teratoma formation.
Inventor(s):	Deisher; Theresa A. (Seattle, WA)
Assignee:	AVM Biotechnology, LLC (Seattle, WA)
Application Number:	13/342,704
Patent Claims:	1. A method for producing an isolated therapeutic recombinant biologic polypeptide or protein for treating a disease comprising transfecting a synthetically-produced Pluripotent Stem Cell (spPSC) with a nucleic acid that encodes for said therapeutic recombinant biologic polypeptide or protein, under conditions wherein the polypeptide or protein is expressed by said spPSC, and the polypeptide or protein is then isolated from the spPSC, and the spPSC is produced from a cell of an animal. 2. The method of claim 1, wherein the therapeutic recombinant biologic polypeptide or protein is selected from the group consisting of: growth hormones, cytotoxic biologics, and monoclonal antibodies. 3. The method of claim 1 wherein the therapeutic biologic polypeptide or protein is selected from the group consisting of erythropoietin, factor VIII, factor IX, thrombin, an antibody or antibody fragment, alpha interferon, interferon alpha 2A and 2B, beta interferon, growth hormone, antihemophilic factor, G-CSF, GM-CSF, a soluble receptor, TGF-.beta., bone morphogenic proteins (BMP), TGF.alpha., interleukin 2, .beta.-glucocerebrosidase or an analogue thereof, alpha1-proteinase inhibitor, fibrin, fibrinogen, von Willebrand factor, imiglucerase, agalsidase beta, laronidase, glucosidase alpha, thyrotropin alpha, and thymosin alpha. 4. The method of claim 2 wherein the antibody or antibody fragment binds to a target, wherein said target is selected from the group consisting of a tumor necrosis factor (TNF) molecule, a tumor necrosis factor receptor (TNFR), a growth factor receptor, a vascular endothelial growth factor (VEGF) molecule, interleukin 1, interleukin 4, interleukin 6, interleukin 11, interleukin 12, gamma interferon, receptor activator of nuclear factor kappa-B ligand (RANKL) and Blys. 5. The method of claim 2 wherein said soluble receptor binds to a target selected from the group consisting of TNF.alpha., TNF.beta. and Blys. 6. The method of claim 1 further comprising immortalizing the transfected spPSC. 7. The method of claim 6 further comprising inducing differentiation of the transfected, immortalized spPSCs. 8. The method of claim 1 further comprising inducing differentiation of the transfected spPSCs. 9. The method of claim 8 further comprising immortalizing the transfected, differentiated cells. 10. The method of claim 1 wherein the spPSC is selected from the group consisting of transfected non-pluripotent cells, pluripotent stem cells produced by Somatic cell nuclear transfer (SCNT pluripotent stem cells), pluripotent stem cells produced by Altered nuclear transfer, oocyte assisted reprogramming (ANT-OAR pluripotent stem cells) and pluripotent stem cells produced by parthenogenesis (PGA pluripotent).

Details for Patent 9,512,200

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	05/23/1994	⤷ Try a Trial	2031-01-03
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	09/22/1999	⤷ Try a Trial	2031-01-03
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979	04/24/2003	⤷ Try a Trial	2031-01-03
Genzyme Corporation	FABRAZYME	agalsidase beta	For Injection	103979	10/10/2003	⤷ Try a Trial	2031-01-03
Biomarin Pharmaceutical Inc.	ALDURAZYME	laronidase	Injection	125058	04/30/2003	⤷ Try a Trial	2031-01-03
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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