Department of Biotechnology, Delft University of Technology, Delft, The Netherlands.
Department of Biotechnology, Delft University of Technology, Delft, The Netherlands.
Trends Biotechnol. 2014 Apr;32(4):210-20. doi: 10.1016/j.tibtech.2014.02.001. Epub 2014 Mar 11.
The purification of biopharmaceuticals is commonly considered the bottleneck of the manufacturing process. Increasing product diversity, along with growing regulatory and economic constraints raise the need to adopt new rational, systematic, and generally applicable process development strategies. Liquid chromatography is the key step in most purification processes and a well-understood unit operation, yet this understanding is still rarely effectively utilized during process development. Knowledge of the composition of the mixture, the molecular properties of the solutes and how they interact with the resins are required to rationalise the design choices. Here, we provide an overview of the advances in the determination and measurement of these properties and interactions, and outline their use throughout the different stages of downstream process development.
生物制药的纯化通常被认为是制造过程的瓶颈。产品多样性的增加，以及日益严格的监管和经济限制，都需要采用新的合理、系统和普遍适用的工艺开发策略。液相色谱是大多数纯化过程中的关键步骤，也是一种被充分理解的单元操作，但在工艺开发过程中，这种理解仍然很少被有效利用。需要了解混合物的组成、溶质的分子性质以及它们与树脂的相互作用，以合理优化设计选择。在这里，我们概述了这些性质和相互作用的测定和测量方面的进展，并概述了它们在下游工艺开发的不同阶段的应用。
