Importance of cynomolgus monkeys in development of monoclonal antibody drugs.

Autor: Iwasaki K; Pharmacokinetics and Bioanalysis Center, Shin Nippon Biomedical Laboratories, Ltd., 2-1-1 Fushimi-machi, Chuo-ku, Osaka 541-0044, Japan. Electronic address: iwasaki-kazuhide@snbl.co.jp., Uno Y; Pharmacokinetics and Bioanalysis Center, Shin Nippon Biomedical Laboratories, Ltd., 16-1 Minami Akasaka, Kainan, Wakayama 642-0017, Japan., Utoh M; Pharmacokinetics and Bioanalysis Center, Shin Nippon Biomedical Laboratories, Ltd., 16-1 Minami Akasaka, Kainan, Wakayama 642-0017, Japan., Yamazaki H; Showa Pharmaceutical University, 3-3165 Tamagawagakuen, Machida, Tokyo 194-8543, Japan.
Jazyk: angličtina
Zdroj: Drug metabolism and pharmacokinetics [Drug Metab Pharmacokinet] 2019 Feb; Vol. 34 (1), pp. 55-63. Date of Electronic Publication: 2018 Mar 20.
DOI: 10.1016/j.dmpk.2018.02.003
Abstrakt: 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.
(Copyright © 2018 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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