IP Library Granted Patent US 7,410,779
Granted Patent B2
US 7,410,779 · App. 11/330,353 · Granted Aug 12, 2008

Fusion polypeptides of human serum albumin and a therapeutically active polypeptide

Assignee: Novozymes Biopharma UK Limited
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Quick Facts
Patent No.
US 7,410,779
App. No.
11/330,353
Granted
Aug 12, 2008
Kind
B2
Abstract

The invention includes biologically active polypeptides comprising a therapeutically active polypeptide fused to human serum albumin or a variant of human serum albumin, methods for the preparation of such fusion polypeptides, nucleotide sequences encoding such fusion polypeptides, expression cassettes comprising such nucleotide sequences, self-replicating plasmids containing such expression cassettes, and pharmaceutical compositions containing such fusion polypeptides.

Claims (44)

1. A nucleic acid molecule comprising a polynucleotide encoding a fusion protein wherein said fusion protein comprises a hormone and a mature form of albumin, wherein (i) said fusion protein has a higher plasma stability than the unfused hormone, (ii) said fusion protein retains the therapeutic activity of the unfused hormone, (iii) and said mature form of albumin is located either at the N-terminus or C-terminus of said fusion protein.

2. The nucleic acid molecule of claim 1 , wherein said fusion protein comprises an N-terminal methionine.

3. The nucleic acid molecule of claim 1 , wherein said fusion protein comprises a peptide linker.

4. The nucleic acid molecule of claim 1 , wherein said fusion protein comprises a secretion signal sequence.

5. The nucleic acid molecule of claim 1 , wherein said hormone is fused to the N-terminal end of said mature form of albumin.

6. The nucleic acid molecule of claim 1 , wherein said hormone is fused to the C-terminal end of said mature form of albumin.

7. The nucleic acid molecule of claim 1 , which further comprises a heterologous polynucleotide.

8. The nucleic acid molecule of claim 7 , wherein said heterologous polynucleotide is a vector sequence.

9. The nucleic acid molecule of claim 7 , wherein said heterologous polynucleotide is a promoter sequence.

10. The nucleic acid molecule of claim 9 , wherein said promoter sequence is a promoter selected from:

(a) a hybrid promoter;

(b) a constitutive promoter;

(c) a regulatable promoter;

(d) a yeast phosphoglycerate kinase (PGK) promoter;

(e) a yeast glyceraldehyde-3-phosphate dehydrogenase (GDP) promoter;

(f) a yeast lactase (LAC4) promoter;

(g) a yeast enolase (ENO) promoter;

(h) a yeast alcohol dehydrogenase (ADH) promoter;

(i) a yeast phosphatase (PHO5) promoter;

(j) a lambda bacteriophage P L promoter;

(k) a lambda bacteriophage P R promoter;

(l) a tryptophan P trp promoter; and

(m) a lactose P lac promoter.

11. The nucleic acid molecule of claim 7 , wherein said heterologous polynucleotide is a selectable marker.

12. The nucleic acid molecule of claim 11 , wherein said selectable marker is a selectable marker selected from:

(a) the URA3 gene;

(b) geneticin resistance;

(c) metal iron resistance; and

(d) ampicillin resistance.

13. The nucleic acid molecule of claim 7 , wherein said heterologous polynucleotide is a region for termination of transcription.

14. The nucleic acid molecule of claim 1 , wherein said nucleic acid molecule is part of an expression cassette.

15. A vector comprising the nucleic acid molecule of claim 1 .

16. An isolated host cell comprising the nucleic acid molecule of claim 1 .

17. An isolated host cell comprising the vector of claim 15 .

18. The isolated host cell of claim 16 or 17 , wherein said isolated host cell is prokaryotic or eukaryotic.

19. The isolated host cell of claim 18 , wherein said isolated host cell is a yeast cell.

20. The isolated host cell of claim 19 , wherein said yeast cell is S. cerevisiae.

21. The isolated host cell of claim 18 , wherein said isolated host cell is an animal cell.

22. The isolated host cell of claim 21 , wherein said animal cell is a CHO cell or a COS cell.

23. The isolated host cell of claim 18 , wherein said isolated host cell is a fungi cell.

24. A method for producing a fusion protein comprising:

(a) culturing the isolated host cell of claim 16 under conditions suitable to produce the fusion protein encoded by said polynucleotide; and

(b) recovering said fusion protein.

25. A fusion protein produced by the method of claim 24 .

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 7, 2010
From: NOVOZYMES BIOPHARMA UK LIMITED
To: NOVOZYMES BIOPHARMA DK A/S
Reel/Frame 025105/0517 →
CHANGE OF NAME Recorded Dec 31, 2007
From: NOVOZYMES DELTA LIMITED
To: NOVOZYMES BIOPHARMA UK LIMITED
Reel/Frame 020299/0491 →
CHANGE OF NAME Recorded Dec 31, 2007
From: DELTA BIOTECHNOLOGY LIMITED
To: NOVOZYMES DELTA LIMITED
Reel/Frame 020299/0814 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 11, 2006
From: AVENTIS BEHRING L.L.C.
To: DELTA BIOTECHNOLOGY LTD.
Reel/Frame 017921/0492 →
Priority Claims (2)
FR 92 01064 · Jan 31, 1992 · national
FR PCT/FR93/00085 · Jan 28, 1993 · national
Continuity (6)
Division 1023762400 · Sep 10, 2002
Division 0998418600 · Oct 29, 2001
Continuation 0925853200 · Feb 26, 1999
Division 0879768900 · Jan 31, 1997
Continuation 0825692700 · Jul 28, 1994
Related Publication 20060105429A1 · May 18, 2006