Department of Antibody Discovery and Protein Engineering, MedImmune Ltd., Milstein Building, Granta Park, Cambridge CB21 6GH, UK.
Int J Pharm. 2013 Jan 2;440(1):83-98. doi: 10.1016/j.ijpharm.2011.12.039. Epub 2011 Dec 30.
Antibodies are well established in mainstream clinical practice and present an exciting area for collaborative research and development in industry and academia alike. In this review, we will provide an overview of the current market and an outlook to 2015, focussing on whole antibody molecules while acknowledging the next generation scaffolds containing variable fragments. The market will be discussed in the context of disease targets, particularly in the areas of oncology and immune disorders which generate the greatest revenue by a wide margin. Emerging targets include central nervous system disorders which will also stimulate new delivery strategies. It is becoming increasingly apparent that a better understanding of bioprocessing is required in order to optimize the steps involved in the preparation of a protein prior to formulation. The latter is outside the scope of this review and nor is it our intention to discuss protein delivery and pharmacokinetics. The challenges that lie ahead include the discovery of new disease targets and the development of robust bioprocessing operations.
抗体在主流临床实践中已经得到广泛应用,为工业界和学术界的合作研究和开发带来了令人兴奋的领域。在这篇综述中,我们将概述当前的市场情况,并展望 2015 年,重点关注全抗体分子,同时承认包含可变片段的下一代支架。将根据疾病靶点讨论市场,特别是在肿瘤学和免疫紊乱领域,这些领域的收入遥遥领先。新兴靶点包括中枢神经系统疾病,这也将刺激新的给药策略。越来越明显的是,为了优化在制剂前制备蛋白质所涉及的步骤,需要更好地了解生物加工。后者不在本综述的范围内,我们也不打算讨论蛋白质的传递和药代动力学。未来的挑战包括发现新的疾病靶点和开发强大的生物加工操作。