PDF(Pubmed)
Abstract：
Therapeutic monoclonal antibody (mAb) development and the processes for manufacturing drug substance have evolved since the first approval of the mAb in 1986. As the past is often the prologue to the future, the history of these technologies has been classified here into three eras, leading to speculation about what the next era may hold with regard to development and manufacturing strategies, as well as the potential impacts to patients. The substantial increase in production culture titers and bioreactor production volumes and the availability of large-scale contract manufacturing facilities could translate into improved global access for these therapies and an expansion of indications for therapeutic antibodies.
摘要：
自1986年mAb首次批准以来，治疗性单克隆抗体（mAb）的开发和生产药物的方法已经发展。因为过去往往是未来的序幕，这些技术的历史在这里被分为三个时代，导致人们猜测下一个时代在发展和制造战略方面可能会发生什么，以及对患者的潜在影响。生产培养滴度和生物反应器产量的大幅增加以及大规模合同生产设施的可用性可以转化为这些疗法的全球可获得性的改善和治疗性抗体适应症的扩大。
