Sequence analysis of therapeutic monoclonal antibody
10.16438/j.0513-4870.2019-0255
- VernacularTitle:单克隆抗体药物序列分析的审评思考
- Author:
Lian-quan QI
1
;
Yu BAI
1
;
Jian-hui LUO
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
- Publication Type:Research Article
- Keywords:
sequence analysis;
monoclonal antibody;
mass spectrometry;
next generation sequencing
- From:
Acta Pharmaceutica Sinica
2019;54(11):2113-2117
- CountryChina
- Language:Chinese
-
Abstract:
Sequence analysis of DNA, mRNA and protein is an essential component of biologics or bioprocess development. Analysis of sequences at the DNA, mRNA, and protein levels after the transfer of the gene of interest into a host cell is an important part of quality control. This article reviews the application of new technologies such as next-generation sequencing and LC-MS/MS in biological drug development such as monoclonal antibodies. These techniques have different requirements in term of cost, handling time and expertise. Selecting an appropriate technique with a sound rationale at different stages of drug development will add to the success rate of research and development, and ensure product quality, thus ensuring the clinical efficacy and safety.
