Claims for Patent: 8,106,158

Summary for Patent: 8,106,158

Title:	Compositions and methods for fusion protein separation
Abstract:	The present invention relates to compositions and methods for fusion protein separation utilizing a peptide linker comprising a novel thrombin cleavage site.
Inventor(s):	Kim; Sujeong (Seoul, KR), Kim; Jong-Mook (Seoul, KR), Xu; Song Shan (Beijing, CN)
Assignee:	ViroMed Co., Ltd. (KR)
Application Number:	12/431,687
Patent Claims:	1. A chimeric protein comprising a protein of interest, a fusion partner, and a peptide linker interposed there between, wherein said protein of interest is linked to the N-terminus of said peptide linker and said fusion partner is linked to the C-terminus of said peptide linker or said protein of interest is linked to the C-terminus of said peptide linker and said fusion partner is linked to the N-terminus of said peptide linker, wherein said peptide linker consists of the sequence: X1-X2-Ser-Pro-X3-X4-X5 (SEQ ID NO: 44) wherein, X1 is two to ten amino acid residues that are the same or different from each other; X2 is glycine; X3 is arginine or lysine; X4 is alanine or glycine; and X5 is a non-acidic amino acid, wherein (a) said fusion partner is an affinity peptide; (b) said protein of interest is selected from the group consisting of human interleukin (IL)-11, thymosin .beta.4, thymosin .alpha.1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-13, IL-15, IL-18, Protease-activated receptor 1(PAR1), PAR3, PAR4, RANTES, stromal cell-derived factor-1.alpha., monocyte chemotactic protein, stem cell factor, FLT-3L, parathyroid hormone, thrombopoietin, epidermal growth factor, basic fibroblast growth factor, insulin-like growth factor, granulocyte-macrophage colony stimulating factor, granulocyte colony stimulating factor, macrophage colony stimulating factor, platelet-derived growth factor, transforming growth factor (TGF)-.beta.1, tumor necrosis factor (TNF)-.alpha., interferon (IFN)-.alpha., IFN-.beta., IFN-.gamma., hepatocyte growth factor, vascular endothelial growth factor and immunoglobulin heavy chain, wherein said chimeric protein is non-naturally occurring; or (c) said fusion partner is an affinity peptide and said protein of interest is selected from the group consisting of human interleukin (IL)-11, thymosin .beta.4, thymosin .alpha.1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-13, IL-15, IL-18, Protease-activated receptor 1 (PAR1), PAR3, PAR4, RANTES, stromal cell-derived factor-1.alpha., monocyte chemotactic protein, stem cell factor, FLT-3L, parathyroid hormone, thrombopoietin, epidermal growth factor, basic fibroblast growth factor, insulin-like growth factor, granulocyte-macrophage colony stimulating factor, granulocyte colony stimulating factor, macrophage colony stimulating factor, platelet-derived growth factor, transforming growth factor (TGF)-.beta.1, tumor necrosis factor (TNF)-.alpha., interferon (IFN)-.alpha., IFN-.beta., IFN-.gamma., hepatocyte growth factor, vascular endothelial growth factor and immunoglobulin heavy chain. 2. The chimeric protein of claim 1, wherein X1 is four to ten amino acid residues. 3. The chimeric protein of claim 2, wherein X1 comprises proline and arginine. 4. The chimeric protein of claim 1, wherein X5 is selected from the group consisting of serine, alanine, asparagine, valine, leucine, isoleucine, lysine, phenylalanine, tyrosine, and tryptophan. 5. The chimeric protein of claim 1, wherein said affinity peptide is selected from the group consisting of glutathione-S-transferase (GST), maltose binding protein (MBP), hexahistidine, T7 peptide, ubiquitin, Flag peptide, c-myc peptide, polyarginine, polycysteine, polyphenylalanine, BTag, galactose binding domain, cellulose binding domain (CBD), thioredoxin, staphylococcal protein A, streptococcal protein G, calmodulin, beta-galactosidase, chloramphenicol acetyltransferase, S-peptide, streptavidin, His-tag, and Strep-tag. 6. The chimeric protein of claim 1, wherein said protein of interest is selected from the group consisting of human IL11, thymosin .beta.4, IL-6 and PAR4. 7. The chimeric protein of claim 1, wherein said protein of interest is linked to the N-terminus of said peptide linker and said fusion partner is linked to the C-terminus of said peptide linker. 8. The chimeric protein of claim 1, wherein said protein of interest is linked to the C-terminus of said peptide linker and said fusion partner is linked to the N-terminus of said peptide linker.

Details for Patent 8,106,158

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2025-04-20