Gronemeyer Petra, Ditz Reinhard, Strube Jochen
Institute for Separation and Process Technology, Clausthal University of Technology, Leibnizstraße 15, D-38678 Clausthal-Zellerfeld, Germany.
Bioengineering (Basel). 2014 Oct 1;1(4):188-212. doi: 10.3390/bioengineering1040188.
A steady increase of product titers and the corresponding change in impurity composition represent a challenge for development and optimization of antibody production processes. Additionally, increasing demands on product quality result in higher complexity of processes and analytics, thereby increasing the costs for product work-up. Concentration and composition of impurities are critical for efficient process development. These impurities can show significant variations, which primarily depend on culture conditions. They have a major impact on the work-up strategy and costs. The resulting "bottleneck" in downstream processing requires new optimization, technology and development approaches. These include the optimization and adaptation of existing unit operations respective to the new separation task, the assessment of alternative separation technologies and the search for new methods in process development. This review presents an overview of existing methods for process optimization and integration and indicates new approaches for future developments.
产品滴度的稳步提高以及杂质组成的相应变化，对抗体生产工艺的开发和优化构成了挑战。此外，对产品质量要求的不断提高导致工艺和分析的复杂性增加，从而增加了产品后处理的成本。杂质的浓度和组成对于高效的工艺开发至关重要。这些杂质可能会有显著变化，这主要取决于培养条件。它们对后处理策略和成本有重大影响。下游加工中出现的“瓶颈”需要新的优化、技术和开发方法。这些方法包括针对新的分离任务对现有单元操作进行优化和调整、评估替代分离技术以及在工艺开发中寻找新方法。本综述概述了现有的工艺优化和整合方法，并指出了未来发展的新途径。
