pharmjournalРазработка и регистрация лекарственных средствDrug development & registration2305-20662658-5049LLC «CPHA»pharmjournal-294Research ArticleБИОТЕХНОЛОГИЯBIOTECHNOLOGYДАУНСТРИМ-ПРОЦЕСС ОЧИСТКИ БИОФАРМАЦЕВТИЧЕСКИХ БЕЛКОВDOWNSTREAM PROCESS OF BIOPHARMACEUTICALSГусаровД. А.GusarovD. A.noemail@neicon.ruНаучно-производственная биотехнологическая платформа «ЭкспертБИОТЕ»R&D and Pilo Plant Biotechnological Platform «ExpertBIOTECH»201609012019038899Copyright © Гусаров Д.А., 20192019Гусаров Д.А.Gusarov D.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmjournal.ru/jour/article/view/294

Развитие биофармацевтической отрасли начинается с разработки эффективных продуцентов. Однако чем сложнее белок и его продуцент, тем большее количество примесей, среди которых эндотоксины, белки хозяина, вирусы, родственные примеси, агрегаты и высокомолекулярные контамитанты, синтезируется или накапливается в ходе процесса получения. Статья описывает под ходы к выделению и очистке биофармацевтических белков (даунстрим-процесс). Обсуждаются основные хроматографические и нехроматографические методы.

The development of the biopharmaceuticals begins with the development of effective producers. But the more complex protein and its producer, the greater the amount of impurities is synthesized or accumulated during the upstream process. Among them are as follows: bacterial endotoxins, viruses, host cell proteins, related impurities, aggregates and high molecular weight admixtures etc. This article describes approaches to the downstream process purification of biopharmaceutical proteins. We discuss the main chromatography and non-chromatographical methods.

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