Claims for Patent: 9,580,488

Summary for Patent: 9,580,488

Title:	Fusion tags and expression vector system for the expression of human parathyroid hormone (rhPTH)
Abstract:	The present invention provides for fusion tags of 20 to 40 amino acids having a sequence as given in FIG. 1, fusion tags sharing homology with these fusion tags, or hybrid fusion tags comprising sequences of FIG. 1. The invention further provides an expression vector system comprising a fusion tag of the invention, and a process of obtaining recombinant human parathyroid hormone by using the fusion tags and the expression vector system of the invention.
Inventor(s):	Chandrashekaran; Siddamadappa (Bangalore, IN), Hemalatha; Venkat (Bangalore, IN)
Assignee:
Application Number:	14/653,897
Patent Claims:	1. A recombinant fusion tag of 20-40 amino acid for expression and purification of recombinant human parathyroid hormone (rhPTH), said fusion tag comprising an amino acid sequence selected from the group consisting of: (a) the amino acid sequence set forth in SEQ ID NO.1; (b) the amino acid sequence set forth in SEQ ID NO.2; (c) the amino acid sequence set forth in SEQ ID NO.3; (d) the amino acid sequence set forth in SEQ ID NO.4; (e) the amino acid sequence set forth in SEQ ID NO.5; (f) the amino acid sequence set forth in SEQ ID NO.6; and (g) the amino acid sequence set forth in SEQ ID NO.7. 2. A polynucleotide encoding the recombinant fusion tag of claim 1. 3. A recombinant vector comprising the polynucleotide of claim 2. 4. An expression vector comprising the polynucleotide of claim 2. 5. The expression vector of claim 4, wherein the vector includes a pET28a vector backbone. 6. The expression vector of claim 4, wherein the fusion tag is fused with a His-tag, followed by a TEV cleavage site and rhPTH. 7. The recombinant fusion tag of claim 1, wherein the tag comprises the amino acid sequence set forth in SEQ ID NO:1. 8. The recombinant fusion tag of claim 1, wherein the tag comprises the amino acid sequence set forth in SEQ ID NO:2. 9. The recombinant fusion tag of claim 1, wherein the tag comprises the amino acid sequence set forth in SEQ ID NO:3. 10. The recombinant fusion tag of claim 1, wherein the tag comprises the amino acid sequence set forth in SEQ ID NO:4. 11. The recombinant fusion tag of claim 1, wherein the tag comprises the amino acid sequence set forth in SEQ ID NO:5. 12. The recombinant fusion tag of claim 1, wherein the tag comprises the amino acid sequence set forth in SEQ ID NO:6. 13. The recombinant fusion tag of claim 1, wherein the tag comprises the amino acid sequence set forth in SEQ ID NO:7. 14. A process for obtaining recombinant human parathyroid hormone (rhPTH), said process comprising: (a) synthesizing a DNA that encodes a fusion tags of 20-40 amino acid of claim 1; (b) preparing a genetic construct that encodes a fusion protein comprising the fusion tag of step (a) and rhPTH; (c) cloning the construct of step (a) into an expression vector; (d) expressing the fusion protein in E. coli; (e) obtaining the rhPTH from the fusion protein; and (f) partially purifying the rhPTH.

Details for Patent 9,580,488

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2032-12-21