Overview of Determination Methods for Deamination Reaction of Biotech Drugs
10.3870/j.issn.1004-0781.2019.02.002
- VernacularTitle:生物技术药物脱酰胺化检测方法概述
- Author:
Heng LI
1
;
Yannan HE
;
Jisheng MA
;
Shanshan LIU
;
Zhaohui ZHOU
Author Information
1. 武汉药品医疗器械检验所
- Keywords:
Biotech drug;
Deamidation;
Isoaspartic acid;
Quality control;
Determination method
- From:
Herald of Medicine
2019;38(2):147-152
- CountryChina
- Language:Chinese
-
Abstract:
Quality control of biotech drugs has attracted increasing attentions in recent years. Deamidation reaction is one of the major concerns in quality control of biotech drugs, due to the generation of isoaspartic acid(isoAsp) . This paper describes the deamidation of asparagine(Asn) residues and its effects on the biological drugs. The detection methods currently used in China and overeas for this reaction, including pretreatment protocols and instrumental analysis were described. The identification and determination of isoaspartyl sites were also described in detail, along with the positive impact on the development of biotech drugs in China by the studies on deamidation reactions.
