| 主权项 |
1. A process for producing a lyophilized pharmaceutical composition containing a protein, comprising the steps of:
(i) obtaining a solution comprising the protein in one or more containers; (ii) placing the one or more containers within a chamber of a lyophilizing unit; (iii) reducing the temperature to an initial freezing temperature of −60° C. to −25° C. at a rate of 0.2° C. to 2.0° C. per minute, and holding the temperature at the initial freezing temperature for 1 to 6 hours to form a frozen solution; (iv) increasing the temperature to an annealing temperature of the frozen solution of −30° C. to −10° C. at a rate of 0.2° C. to 2.0° C. per minute, and holding the temperature at the annealing temperature for 1 to 10 hours; (v) reducing the temperature to a refreezing temperature of −60° C. to −25° C. at a rate of 0.2° C. to 2.0° C. per minute, and holding the temperature at the refreezing temperature for 1 to 6 hours; (vi) reducing the pressure of the chamber to 50 to 500 mT, and continuing to hold the temperature at the refreezing temperature for an additional 0 to 4 hours; (vii) increasing the temperature to a primary drying temperature of −30° C. to −5° C. at a rate of 0.2° C. to 2.0° C. per minute, and holding the temperature at the primary drying temperature for 10 to 72 hours; (viii) increasing the temperature to a secondary drying temperature of 5° C. to 30° C. at a rate of 0.2° C. to 2.0° C. per minute, and holding the temperature at the secondary drying temperature for 2 to 25 hours; and (ix) increasing the pressure of the chamber to partial atmospheric pressure. |
