Manufacturing Sciences & Technology, Bristol-Myers Squibb, Co., 6000 Thompson Road, East Syracuse, NY 13057, USA.
Trends Biotechnol. 2010 May;28(5):253-61. doi: 10.1016/j.tibtech.2010.02.001. Epub 2010 Mar 19.
The rapid development of high-yielding and robust manufacturing processes for monoclonal antibodies is an area of significant focus in the biopharmaceutical landscape. Advances in mammalian cell culture have taken titers to beyond the 5 g/l mark. Platform approaches to downstream process development have become widely established. Continuous evolution of these platforms is occurring as experience with a wider range of products is accrued. The increased cell culture productivity has shifted the attention of bioprocess development to operations downstream of the production bioreactor. This has rejuvenated interest in the use of non-chromatographic separation processes. Here, we review the current state-of-the-art industrial production processes, focusing on downstream technologies, for antibodies and antibody-related products and discuss future avenues for evolution.
高产且稳健的单克隆抗体制造工艺的快速发展是生物制药领域的一个重点关注领域。哺乳动物细胞培养技术的进步使滴度超过了 5g/L。下游工艺开发的平台方法已经得到广泛应用。随着更广泛产品经验的积累，这些平台正在不断发展。细胞培养生产力的提高使生物工艺开发的注意力转移到生产生物反应器下游的操作上。这重新激发了人们对使用非色谱分离工艺的兴趣。在这里，我们回顾了当前用于抗体和抗体相关产品的工业生产工艺的最新技术，重点是下游技术，并讨论了未来的发展方向。
