Systematic Approach to Production Technology Development for Therapeutic Proteins (Using Insulin-Glargine as an Example)

作者：Gusarov D A^*; Byrikhina D V; Izhaeva F M; Gosudarev A I; Mikhailov P V; Gusarova V D; Budyl'skaya T A; Mironov A F; Shvets V I

来源：Pharmaceutical Chemistry Journal, 2015, 48(12): 822-829.

DOI：10.1007/s11094-015-1203-2

• systematic approach
• biopharmaceuticals
• insulin glargine
• upstream bioprocess
• downstream process
• fish-bone (Ishikawa) diagram

The development of domestic biogenerics to replace imported drugs is among the main goals of the Pharma-2020 strategy. Insulin glargine, a therapeutic polypeptide with sustained glycolytic activity, is one of the most important biogenerics. A systematic approach to the rational design of biotechnology processes for producing pharmaceuticals such as recombinant proteins was described. Use of a systematic approach using insulin glargine as an example facilitated its rapid and effective production technology development.

• 出版日期2015-3