DOWNSTREAM PROCESS OF BIOPHARMACEUTICALS

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...

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Bibliographic Details
Main Author: D. A. Gusarov
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Series:Разработка и регистрация лекарственных средств
Subjects:
Online Access:https://www.pharmjournal.ru/jour/article/view/294
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Summary: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.
ISSN:2305-2066
2658-5049