Stein K E
Division of Monoclonal Antibodies, Food and Drug Administration, Bethesda, MD 20892-0029, USA.
Trends Biotechnol. 1997 Mar;15(3):88-90. doi: 10.1016/S0167-7799(96)10075-5.
Using current monoclonal antibody technology one can now produce a humanized antibody to virtually any target antigen that can be identified. Consequently, one would expect there to be more approved monoclonal antibody products. Inadequate product development at both the preclinical and clinical stages has contributed to the overall lack of success. This article discusses some of the obstacles to successful product development and offers suggestions to overcoming them. The key to monoclonal antibody development, as with other biological products, is understanding the properties of the product itself, to have some proof of concept before embarking on clinical studies, and to adequately design and power the pivotal trial.
利用当前的单克隆抗体技术，现在几乎可以针对任何能够被识别的靶抗原生产人源化抗体。因此，人们预计会有更多获批的单克隆抗体产品。临床前和临床阶段产品开发不足导致了总体上的不成功。本文讨论了成功进行产品开发的一些障碍，并提出了克服这些障碍的建议。与其他生物制品一样，单克隆抗体开发的关键在于了解产品本身的特性，在开展临床研究之前要有一些概念验证，并对关键试验进行充分的设计和规划。
