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Bioengineering 2014, 1(4), 188-212; doi:10.3390/bioengineering1040188

Trends in Upstream and Downstream Process Development for Antibody Manufacturing

Institute for Separation and Process Technology, Clausthal University of Technology, Leibnizstraße 15, D-38678 Clausthal-Zellerfeld, Germany
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Received: 1 August 2014 / Revised: 12 September 2014 / Accepted: 29 September 2014 / Published: 1 October 2014
(This article belongs to the Special Issue Biopharmaceutical Process Development)
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Abstract

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. View Full-Text
Keywords: process development; upstream processing; downstream processing; process integration; host cell proteins process development; upstream processing; downstream processing; process integration; host cell proteins
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Gronemeyer, P.; Ditz, R.; Strube, J. Trends in Upstream and Downstream Process Development for Antibody Manufacturing. Bioengineering 2014, 1, 188-212.

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