Crystalline human proinsulin and process for its production

C - Chemistry – Metallurgy – 07 – K

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167/122, 530/7.4

C07K 14/62 (2006.01) A61K 38/28 (2006.01)

Patent

CA 1339045

This disclosure provides a crystalline human proinsulin, the preparation of which comprises (a) preparing an aqueous mixture containing from about 5 to about 50 mg/ml human proinsulin, from about 0.1 to about 5 mg/ml of a phenolic substance, from about 0.03 to about 0.6 milliequivalents/ml of a salt of a cation selected from the group consisting of lithium, calcium, sodium, potassium, ammonium, magnesium, and barium, and from about 0.2 to about 5 milliequivalents of zn+2 cation; (b) adjusting the aqueous mixture to a pH in the range of from about 5.4 to about 6.5; (c) allowing crystal formation to occur; and (d) recovering crystalline human proinsulin from the aqueous mixture.

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