| 摘要 |
PROBLEM TO BE SOLVED: To provide an aqueous formulation comprising water and a protein, and methods of making the same.SOLUTION: The invention is based on a dialysis filtration process in which a first solution containing a target protein is dialyzed and filtered with water as a dialysis filtration solvent. The process is performed, for example so that replacement with water of given capacity (e.g., replacement of 5 time capacity) may exist at least. By performing the method of the invention, the obtained aqueous formulation has a remarkable reduction of the total percent of an excipient compared with an initial protein solution. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductivity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality. |
