METHOD FOR PREPARING CRYSTALLINE INSULIN

摘要

A method for crystallizing insulin or insulin analogs under alkaline conditions and purifying the insulin or insulin analog crystals by filtering through a filter and drying the insulin or insulin analog crystals captured on the filter to produce crystalline insulin or insulin analog crystal compositions is described. In particular aspects, the method may be used to crystalize insulin glargine.

主权项

1: A method for preparing insulin or insulin analog crystals comprising:
(a) providing a solution comprising the insulin or insulin analog, a water miscible organic solvent, a crystal stabilizing agent, wherein the solution has a pH that is at least 1 pH unit greater than the pI of the insulin or insulin analog; and (b) adding a zinc salt to the solution and incubating the solution for a time sufficient for the insulin or insulin analog to crystalize produce the insulin or insulin analog crystals.