IMPROVED PROCESS TO STABILIZE PROTEINS

摘要

An improved process for preventing the formation of protein aggregates in a reconstituted lyophilisate of a pharmaceutical composition of a protein, in which an aqueous buffered solution of the protein is frozen, thawed, divided into compartments of injectable amounts and these compartments are lyophilized which is characterized in that the aqueous buffered solution of the protein contains potassium phosphate buffer as a buffer substance and the ratio of potassium to sodium ions in the solution is at least 10:1, can advantageously be used to produce stable lyophilisates of pharmaceutical compositions.