Preparation of stable zinc insulin analog crystals
First Claim
Patent Images
1. A process of preparing crystalline LysB28 ProB29 -human insulin, which comprises:
- crystallizing LysB28 ProB29 -human insulin from a solution comprising LysB28 ProB29 -human insulin, zinc, at least 0.3N of an organic acid selected from the group consisting acetic, citric, or glycine, and a phenolic at a pH of about 5.5 to about 6.5.
1 Assignment
0 Petitions
Accused Products
Abstract
The present invention discloses a process of preparing a crystalline insulin analog. The process is useful in the purification and manufacture of LysB28 ProB29 -human insulin. LysB28 ProB29 -human insulin is useful in the treatment of diabetes.
-
Citations
11 Claims
-
1. A process of preparing crystalline LysB28 ProB29 -human insulin, which comprises:
- crystallizing LysB28 ProB29 -human insulin from a solution comprising LysB28 ProB29 -human insulin, zinc, at least 0.3N of an organic acid selected from the group consisting acetic, citric, or glycine, and a phenolic at a pH of about 5.5 to about 6.5.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
-
10. A process of preparing crystalline LysB28 ProB29 -human insulin, which comprises:
-
(a) adding phenol at 0.15% to 0.25% on a final volume basis to a solution of LysB28 ProB29 -hI solution at about 1.8 to 2.5 g/L in about 1N acetic acid; (b) adjusting the pH to about 5.9 to about 6.2 with ammonium hydroxide; and (c) adding a zinc salt solution to a final concentration of about 40 to about 400 mg zinc chloride per gram of LysB28 ProB29 -hI. - View Dependent Claims (11)
-
Specification