PROTEIN STABILIZATION FORMULATIONS

摘要

Protein stabilization formulations are provided to stabilize bone morphogenetic proteins(BMP) and growth/differentiation factors(GDF) closely associated therewith in freeze-dried formulations and compositions by using trehalose as an excipient for protecting proteins in freeze-drying, and subsequent storage and refolding. A composition for stabilizing bone morphogenetic proteins(BMP) comprises trehalose in a sufficient amount to stabilize the BMP, and further comprises glycine buffer solution of pH 2.5-3.5, wherein the BMP is rhGDF-5(recombinant human growth/differentiation factor-5). A method for stabilizing the bone morphogenetic proteins(BMP) comprises the steps of: (a) providing a composition comprising at least one bone morphogenetic proteins(BMP) and trehalose in a sufficient amount to stabilize the BMP; and (b) freeze-drying the mixture. Further, a glycine buffer solution of which pH is 2.5 to 3.5 is additionally added in the method.