Importance of cynomolgus monkeys in development of monoclonal antibody drugs

被引：31

作者：

Iwasaki, Kazuhide ^{[1
]}

Uno, Yasuhiro ^{[2
]}

Utoh, Masahiro ^{[2
]}

Yamazaki, Hiroshi ^{[3
]}

机构：

[1] Shin Nippon Biomed Labs Ltd, Pharmacokinet & Bioanal Ctr, Chuo Ku, 2-1-1 Fushimi Machi, Osaka 5410044, Japan

[2] Shin Nippon Biomed Labs Ltd, Pharmacokinet & Bioanal Ctr, 16-1 Minami Akasaka, Wakayama 6420017, Japan

[3] Showa Pharmaceut Univ, 3-3165 Tamagawagakuen, Machida, Tokyo 1948543, Japan

来源：

DRUG METABOLISM AND PHARMACOKINETICS | 2019年 / 34卷 / 01期

关键词：

Monoclonal antibody drugs; Cynomolgus monkeys; Experimental animals; Preclinical studies; New drug development; Neonatal Fc receptor; NEONATAL FC-RECEPTOR; HUMAN PHARMACOKINETICS; POLYMORPHISMS; PREDICTION;

D O I：

10.1016/j.dmpk.2018.02.003

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Animal species used in the preclinical studies for development of monoclonal antibody (mAb) drugs are surveyed in this review. Relevant animal species for preclinical studies of mAb candidates are those express desired epitope of mAb candidates. Cynomolgus monkeys cross-react with mAb drugs much higher than other animal species commonly used in preclinical studies such as absorption, distribution, metabolism and excretion (ADME), efficacy, and toxicity studies, for development of new drugs. Moreover, plasma exposure of the mAb drugs in humans is predicted well from the exposure in the monkeys, and the placental transfer of immunoglobulin G (IgG, all the mAb drugs contain IgG) from mother to fetus is similar between humans and the monkeys from a viewpoint of time course and plasma level of IgG transferred. These observed findings indicate that the monkeys are the most suitable animal species used in the ADME and toxicity studies for development of new mAb drugs. (c) 2018 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

引用

页码：55 / 63

页数：9

共 13 条

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