| 主权项 |
1. A process for drying a protein solution to obtain a dried protein with a specified pH, the process comprising:
a) selecting a target pH for the dried protein, wherein the target pH for the dried protein is between 6.0 and 8.5, b) selecting a target pH for the protein solution wherein the target pH for the protein solution is at least about 0.5 pH units above the target pH for the dried protein selected in step (a), and wherein the target pH for the protein solution is between 7.4 and 11.0, c) obtaining the protein solution at a temperature below 8° C. by steps (i)-(v), wherein the steps (ii)-(v) can be carried out in any order while stirring continuously, i. providing an aqueous phase, ii. adding a protein, iii. optionally adding excipients, iv. adjusting the pH with a non-volatile base and optionally a non-volatile acid to the target pH for the dried protein selected in step (a), v. adjusting the pH with a volatile base to the target pH for the protein solution selected in step (b), and d) drying the protein solution resulting from step (c) to obtain a dried protein with a pH selected in step (a), and wherein the protein is selected from the group consisting of insulin, insulin analogues, insulin derivatives, GLP-1, GLP-1 analogues, GLP-1 derivatives, glucagon and/or any combination thereof. |
