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Details for Patent: 7,090,835

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Details for Patent: 7,090,835

Title:N-terminally chemically modified protein compositions and methods
Abstract: Provided herein are methods and compositions relating to the attachment of water soluble polymers to proteins. Provided are novel methods for N-terminally modifying proteins or analogs thereof, and resultant compositions, including novel N-terminally chemically modified G-CSF compositions and related methods of preparation. Also provided is chemically modified consensus interferon.
Inventor(s): Gabriel; Nancy E. (Newbury Park, CA), Farrar; Christine E. (Newbury Park, CA)
Assignee: Amgen, Inc. (Thousand Oaks, CA)
Filing Date:Mar 26, 2001
Application Number:09/817,725
Claims:1. A preparation comprising a predominant amount of a monopolymer/protein conjugate prepared from a hematopoietic protein having one or more available epsilon amino reactive groups, wherein the monopolymer/protein conjugate has a polyethylene glycol polymer moiety located at the N-terminus but not on an epsilon amino group, and the polyethylene glycol polymer moiety is conjugated via an alpha amino group and, wherein the monopolymer/protein conjugate has a prolonged in vivo biological activity relative to the non-conjugated hematopoietic protein.

2. The preparation of claim 1 wherein the preparation comprises greater than 80% monopolymer/protein conjugate.

3. The preparation of claim 1 wherein the preparation comprises at least 90% monopolymer/protein conjugate.

4. The preparation of claim 1 wherein the preparation comprises greater than 95% monopolymer/protein conjugate.

5. The preparation of claim 1 wherein the preparation comprises at least 99% monopolymer/protein conjugate.

6. A preparation of a monopegylated hematopoietic protein prepared from a hematopoietic protein having one or more available epsilon amino reactive groups, wherein a polyethylene glycol polymer moiety is conjugated predominantly at the N-terminus of the hematopoietic protein and is conjugated via an alpha amino group and wherein the monopegylated hematopoietic protein has a prolonged in vivo biological activity relative to the non-conjugated hematopoietic protein.

7. The hematopoietic protein preparation of claim 1 or 6 wherein the polyethylene glycol has a molecular weight of between about 2 kDa and about 100 kDa.

8. The hematopoietic protein preparation of claim 7 wherein the polyethylene glycol has a molecular weight of about 6 kDa.

9. The hematopoietic protein preparation of claim 7 wherein the polyethylene glycol has a molecular weight of about 12 kDa.

10. The hematopoietic protein preparation of claim 7 wherein the polyethylene glycol has a molecular weight of about 20 kDa.

11. The hematopoietic protein preparation of claim 7 wherein the polyethylene glycol has a molecular weight of about 25 kDa.

12. A pharmaceutical composition comprising (a) the preparation of claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 and (b) a pharmaceutically acceptable diluent, carrier or adjuvant.

13. A pharmaceutical composition comprising (a) the preparation of claim 7 and (b) a pharmaceutically acceptable diluent, carrier or adjuvant.
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