Chemistry: natural resins or derivatives; peptides or proteins; – Peptides of 3 to 100 amino acid residues – 24 amino acid residues in defined sequence
Reexamination Certificate
2008-07-27
2009-10-06
Tsang, Cecilia (Department: 1654)
Chemistry: natural resins or derivatives; peptides or proteins;
Peptides of 3 to 100 amino acid residues
24 amino acid residues in defined sequence
C530S324000, C530S333000, C530S334000, C530S335000, C514S013800
Reexamination Certificate
active
07598343
ABSTRACT:
Pharmaceutical batch(es) or pharmaceutical formulation(s) comprising bivalirudin as the active ingredient, and a method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s). The pharmaceutical batch(es) or pharmaceutical formulation(s) may have a maximum impurity level of Asp9-bivalirudin that does not exceed about 0.6%. Also, the pharmaceutical batch(es) or pharmaceutical formulation(s) may have a reconstitution time that does not exceed about 42 seconds. The method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s) may comprise dissolving bivalirudin in a solvent to form a first solution, efficiently mixing a pH-adjusting solution with the first solution to form a second solution in which the pH-adjusting solution may comprise a pH-adjusting solution solvent, and removing the solvent and the pH-adjusting solution solvent from the second solution.
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Krishna Gopal
Musso Gary
Frommer & Lawrence & Haug LLP
Garman Russell A.
Ha Julie
Kuzmich Sandra
The Medicines Company
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