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

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 biotechnolo...

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Bibliographic Details
Published inPharmaceutical chemistry journal Vol. 48; no. 12; pp. 822 - 829
Main Authors 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.
Format Journal Article
LanguageEnglish
Published New York Springer US 01.03.2015
Springer
Subjects
Biopharmaceuticals
Health aspects
Insulin
Medicine
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
Proteins
upstream bioprocess
biopharmaceuticals
downstream process
fish-bone (Ishikawa) diagram
insulin glargine
systematic approach
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Summary: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.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-015-1203-2