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      Integration of Aqueous Two-Phase Extraction into Downstream Processing

      , ,
      Chemical Engineering & Technology
      Wiley

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          Recent advances in large-scale production of monoclonal antibodies and related proteins.

          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. Copyright 2010 Elsevier Ltd. All rights reserved.
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            Future of antibody purification.

            Antibody purification seems to be safely ensconced in a platform, now well-established by way of multiple commercialized antibody processes. However, natural evolution compels us to peer into the future. This is driven not only by a large, projected increase in the number of antibody therapies, but also by dramatic improvements in upstream productivity, and process economics. Although disruptive technologies have yet escaped downstream processes, evolution of the so-called platform is already evident in antibody processes in late-stage development. Here we perform a wide survey of technologies that are competing to be part of that platform, and provide our [inherently dangerous] assessment of those that have the most promise.
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              Chromatography-free recovery of biopharmaceuticals through aqueous two-phase processing.

              The therapeutic use of proteins has created an increasing demand for feasible and economical methods for both up- and downstream processes. However, whereas upstream processes have attracted substantial investment and commercial attention, downstream processing has been overlooked, causing a production bottleneck that is shifting the costs of production. This review focuses on the use of aqueous two-phase extraction as an option for the downstream processing of therapeutic proteins. It is a potential and promising liquid-liquid extraction technique for the purification of biomolecules, such as monoclonal antibodies, growth factors and hormones, that combines a high selectivity and biocompatibility with an easy scale-up and continuous operation mode.
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                Author and article information

                Journal
                Chemical Engineering & Technology
                Chem. Eng. Technol.
                Wiley
                09307516
                October 2014
                October 2014
                September 09 2014
                : 37
                : 10
                : 1686-1696
                Article
                10.1002/ceat.201400114
                fa75fd3b-ffad-49b2-a3a5-ee04af5c7a07
                © 2014

                http://doi.wiley.com/10.1002/tdm_license_1.1

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