DEAMIDATION - A SOURCE OF MICROHETEROGENEITY IN PHARMACEUTICAL PROTEINS

被引：65

作者：

LIU, DTY

机构：

[1] D.T. Liu is at the Division of Biochemistry and Biophysics, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda

来源：

TRENDS IN BIOTECHNOLOGY | 1992年 / 10卷 / 10期

关键词：

D O I：

10.1016/0167-7799(92)90269-2

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Most protein molecules undergo some degree of spontaneous deamidation in vivo. This process may also occur during the production, isolation, purification, formulation and storage of pharmaceutical proteins. Deamidation is a potential source of microheterogeneity for pharmaceutical proteins, and this is an important issue that needs to be addressed, not only by the manufacturers but also by the national control agencies. This article provides an overview of the scientific and regulatory issues pertinent to deamidation of pharmaceutical proteins.

引用

页码：364 / 369

页数：6

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