Stable composition of GDF-5 and method of storage

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai

Reexamination Certificate

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C514S021200, C530S350000

Reexamination Certificate

active

08058237

ABSTRACT:
Improved compositions and methods are provided for stabilizing a solution of bone morphogenetic protein. The compositions comprise an aqueous solution of GDF-5 and a biocompatible acid, such as hydrochloric, acetic, phosphoric, or trifluoroacetic acid, wherein the solution has a pH of from about 3.0 to about 3.6, thereby providing for improved stability of the GDF-5 protein during handling and prolonged storage at reduced temperatures.

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