Kurata Hideyuki, Ishino Tetsuya, Ohshima Yasuhiro, Yohda Masafumi
Technology General Division, AGC Inc., Tokyo, Japan.
Institute of Engineering, Tokyo University of Agriculture and Technology, Tokyo, Japan.
Front Bioeng Biotechnol. 2022 Mar 21;10:841420. doi: 10.3389/fbioe.2022.841420. eCollection 2022.
Biopharmaceutical industries have advanced significantly after the millennium. Novel biopharmaceuticals have been developed one after another, and blockbuster drugs have been produced. Accompanying the increase in the demand for biopharmaceuticals, a business model called "contract development manufacturing organization (CDMO)" has emerged. A CDMO is entrusted with the development and manufacturing of production processes from pharmaceutical companies. In this review, we identify the success factors of the biopharmaceutical CDMO by analyzing the foundry business for the semiconductor industry. Furthermore, we also review monoclonal antibody production platforms and new technologies that are critical aspects of differentiation strategies in the biopharmaceutical CDMO.
进入千禧年后,生物制药行业取得了显著进展。新型生物制药相继问世,重磅药物不断涌现。随着生物制药需求的增加,一种名为“合同开发生产组织(CDMO)”的商业模式应运而生。CDMO受制药公司委托,负责生产工艺的开发和制造。在本综述中,我们通过分析半导体行业的代工业务来确定生物制药CDMO的成功因素。此外,我们还回顾了单克隆抗体生产平台以及作为生物制药CDMO差异化战略关键方面的新技术。