Invention Grant
- Patent Title: Method for the preparation of growth hormone and antagonist thereof having lower levels of isoform impurities thereof
- Patent Title (中): 具有较低水平异构体杂质的生长激素及其拮抗剂的制备方法
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Application No.: US12405857Application Date: 2009-03-17
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Publication No.: US08148331B2Publication Date: 2012-04-03
- Inventor: Anurag S. Rathore , Stephen B. Lyle , David E. Steinmeyer , Scott I. Allen , John Meyer , Denis M. Boyle , John J. Buckley , Gary V. Johnson
- Applicant: Anurag S. Rathore , Stephen B. Lyle , David E. Steinmeyer , Scott I. Allen , John Meyer , Denis M. Boyle , John J. Buckley , Gary V. Johnson
- Applicant Address: US NY New York
- Assignee: Pfizer Inc.
- Current Assignee: Pfizer Inc.
- Current Assignee Address: US NY New York
- Agent Cregg C. Benson; Ian J. S. Lodovice
- Main IPC: A61K38/16
- IPC: A61K38/16 ; A61K38/27 ; A61K39/385

Abstract:
The present invention is directed generally to recombinant methods for making a desired polypeptide. These method(s) yield a polypeptide product containing reduced levels of isoform impurities thereof. In particular, the present invention is directed to (1) a recombinant method for preparing growth hormone with reduced isoform impurities thereof and (2) a recombinant method for preparing a growth hormone antagonist, such as pegvisomant, and its protein intermediate, also having reduced isoform impurities thereof. More specifically, the isoform impurities that are decreased by methods of the present invention are the trisulfide and des-phe isoform impurities of growth hormone and growth hormone antagonist (or its intermediate), respectively.
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