Pro-insulin aspart structure and method for preparing insulin aspart

US12325732B2 · kind B2 · utility

Assignee

• AMPHASTAR NANJING PHARMACEUTICALS INC · CN

Inventors

• Chuangen TANG · 安丰镇, CN
• Shangshu PAN · 安丰镇, CN
• Xiaorui LIU · 安丰镇, CN
• Cheng LI · Shanghai, CN
• Huaiyan Cui · 安丰镇, CN
• Song Chen · Nanhu, CN
• Haoning Zhang · Nanjing, CN
• Jeffrey Ding · 安丰镇, CN

Key dates

• Filing date: Sep 12, 2018
• Grant date: Jun 10, 2025
• Expiry date: Jul 21, 2041

Classification

• Technology area (CPC C): Chemistry; Metallurgy
• CPC primary: C07K2319/50
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

Provided are a novel pro-insulin aspart structure design and a method for preparing the pro-insulin aspart. The method comprises designing the pro-insulin aspart sequence, constructing a recombinant insulin aspart engineered bacteria, inducing expression of an insulin fusion protein as an inclusion body in the engineered bacteria, and extracting the insulin fusion protein from the engineered bacteria by means of denaturing, renaturing enzymatic digestion, and separation purification operations. By modifying the recombinant leading peptide and C-peptide sequences, the method avoids the need to include a cyanogen bromide cleavage step. In some embodiments, the C-peptide is replaced by a single amino acid which tends to reduce quality loss associated with enzymatic digestion.