Integration of Aqueous Two-Phase Extraction as Cell Harvest and Capture Operation in the Manufacturing Process of Monoclonal Antibodies.

Clicks: 384
ID: 52777
2017
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Abstract
Substantial improvements have been made to cell culturing processes (e.g., higher product titer) in recent years by raising cell densities and optimizing cultivation time. However, this has been accompanied by an increase in product-related impurities and therefore greater challenges in subsequent clarification and capture operations. Considering the paradigm shift towards the design of continuously operating dedicated plants at smaller scales-with or without disposable technology-for treating smaller patient populations due to new indications or personalized medicine approaches, the rising need for new, innovative strategies for both clarification and capture technology becomes evident. Aqueous two-phase extraction (ATPE) is now considered to be a feasible unit operation, e.g., for the capture of monoclonal antibodies or recombinant proteins. However, most of the published work so far investigates the applicability of ATPE in antibody-manufacturing processes at the lab-scale and for the most part, only during the capture step. This work shows the integration of ATPE as a combined harvest and capture step into a downstream process. Additionally, a model is applied that allows early prediction of settler dimensions with high prediction accuracy. Finally, a reliable process development concept, which guides through the necessary steps, starting from the definition of the separation task to the final stages of integration and scale-up, is presented.
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schmidt2017integrationantibodies Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Schmidt, Axel;Richter, Michael;Rudolph, Frederik;Strube, Jochen;
Journal antibodies (basel, switzerland)
Year 2017
DOI
E21
URL
Keywords
aqueous two-phase extraction capture cell harvest continuous phase separation horizontal settler interfacial partitioning process integration static mixer

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