| 主权项 |
1. A method for manufacturing a medical protein formulation, wherein the protein is an antibody,
which comprises providing a composition comprising a medical protein and suspected of containing DNA contaminants, and removing such DNA contaminants by the steps comprising: 1) applying the composition to a protein-A or protein-G affinity column, which binds the medical protein, 2) washing the column to elute non-bound components of the composition, 3) eluting the bound medical protein with an aqueous solution of pH of 2.0 to 3.9 and an ionic concentration of 50 mM or less, thereby forming an acidic aqueous solution of the medical protein having an ionic concentration of 50 mM or less and a pH of 2.0 to 3.9, 4) forming particles containing the DNA contaminants by a step consisting of adjusting the pH of the eluate solution to a pH of from 4.0 to 7.5 by adding a buffer, and 5) removing the particles of step 4),thereby obtaining the medical protein formulation. |
