抗体药物工艺开发需要考虑的因素

Impact factors in the process development for therapeutic antibodies

近10年来,中国抗体药物的研发迅速崛起。抗体药物大多是由哺乳类动物细胞生产,其生产过程漫长而复杂,生产工艺的稳定性和重现性是巨大的挑战,产品质量的一致性更是难以控制。因此,如何开发一个稳定且高产的生产工艺,并可以放大以满足市场的需求,是每家企业必须解决的关键问题。本文结合近年来新技术的发展和个人近20年的工作经验,就工艺开发过程中需要考虑的因素展开讨论。

The research and development of monoclonal antibody in China are rapidly rising in recent 10 years. This is a huge challenge to obtain a robust process and to achieve the consistency of product quality,because most of the antibody drugs are produced from mammalian cells and the production processes are long and complex.Therefore,how to develop a robust and high yield production process,which can be scaled up to meet the market needs,is the key issue that every enterprise must encounter. In this review,combined with the development of new technologies in recent years and the personal 20-year working experience,the factors that need to be considered in process development are discussed.