Yamane-Ohnuki Naoko, Satoh Mitsuo
Antibody Research Laboratories, Research Division, Kyowa Hakko Kirin Co., Ltd., Machida-shi, Tokyo, Japan.
MAbs. 2009 May-Jun;1(3):230-6. doi: 10.4161/mabs.1.3.8328. Epub 2009 May 28.
The clinical success of therapeutic antibodies is demonstrated by the number of antibody therapeutics that have been brought to market and the increasing number of therapeutic antibodies in development. Recombinant antibodies are molecular-targeted therapeutic agents and represent a major new class of drugs. However, it is still very important to optimize and maximize the clinical efficacy of therapeutic antibodies, in part to help lower the cost of therapeutic antibodies by potentially reducing the dose or the duration of treatment. Clinical trials using therapeutic antibodies fully lacking core fucose residue in the Fc oligosaccharides are currently underway, and their remarkable physiological activities in humans in vivo have attracted attention as next-generation therapeutic antibody approaches with improved efficacy. Thus, an industrially applicable antibody production process that provides consistent yields of fully non-fucosylated antibody therapeutics with fixed quality has become a key goal in the successful development of next-generation therapeutic agents. In this article, we review the current technologies for production of therapeutic antibodies with control of fucosylation of the Fc N-glycans.
已上市的抗体治疗药物数量以及处于研发阶段的治疗性抗体数量不断增加，这证明了治疗性抗体在临床上的成功。重组抗体是分子靶向治疗剂，代表了一类重要的新型药物。然而，优化并最大化治疗性抗体的临床疗效仍然非常重要，部分原因是通过潜在地减少剂量或治疗持续时间来帮助降低治疗性抗体的成本。目前正在进行使用Fc寡糖中完全缺乏核心岩藻糖残基的治疗性抗体的临床试验，其在人体体内显著的生理活性作为具有更高疗效的下一代治疗性抗体方法已引起关注。因此，能够以固定质量持续生产完全非岩藻糖基化抗体治疗药物的工业适用抗体生产工艺已成为成功开发下一代治疗剂的关键目标。在本文中，我们综述了目前用于生产可控制Fc N-聚糖岩藻糖基化的治疗性抗体的技术。
