Integrated Continuous Biomanufacturing: Industrialization on the Horizon
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DOI: 10.1002/biot.201800722
Abstract: Continuous bioprocessing has the inherent advantage of higher productivity, which can facilitate implementation of small process trains resulting in cost-effective, lean, and agile manufacturing facilities. Impressive technological advances to enable continuous bioprocessing have been made… read more here.
Keywords: continuous bioprocessing; industrialization horizon; biomanufacturing industrialization; continuous biomanufacturing ... See more keywords
Modeling the Residence Time Distribution of Integrated Continuous Bioprocesses.
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DOI: 10.1002/biot.202000008
Abstract: In response to the biopharmaceutical industry advancing from traditional batch operation to continuous operation, the FDA has published a draft for continuous integrated biomanufacturing [1]. This draft outlines the most important rules for establishing continuous… read more here.
Keywords: modeling residence; residence time; time; process ... See more keywords
Process performance and product quality in an integrated continuous antibody production process
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DOI: 10.1002/bit.26069
Abstract: Continuous manufacturing is currently being seriously considered in the biopharmaceutical industry as the possible new paradigm for producing therapeutic proteins, due to production cost and product quality related benefits. In this study, a monoclonal antibody… read more here.
Keywords: process; product quality; production; integrated continuous ... See more keywords
A common framework for integrated and continuous biomanufacturing
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DOI: 10.1002/bit.27690
Abstract: There is a growing application of integrated and continuous bioprocessing (ICB) for manufacturing recombinant protein therapeutics produced from mammalian cells. At first glance, the newly evolved ICB has created a vast diversity of platforms. A… read more here.
Keywords: continuous biomanufacturing; framework; common framework; integrated continuous ... See more keywords
The design basis for the integrated and continuous biomanufacturing framework
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DOI: 10.1002/bit.27697
Abstract: An 8 ton per year manufacturing facility is described based on the framework for integrated and continuous bioprocessing (ICB) common to all known biopharmaceutical implementations. While the output of this plant rivals some of the largest… read more here.
Keywords: continuous biomanufacturing; framework; basis integrated; design basis ... See more keywords
Improving an intensified and integrated continuous bioprocess platform for biologics manufacturing
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DOI: 10.1002/bit.27768
Abstract: The WuXi Biologics' Ultra‐high Productivity platform (WuXiUP) technology is an innovative and integrated platform of continuous biomanufacturing. Through process intensification, the platform enables continuous manufacturing of almost any type of biologics and delivers processes with… read more here.
Keywords: intensified integrated; continuous bioprocess; process; platform ... See more keywords
An integrated and continuous downstream process for microbial virus‐like particle vaccine biomanufacture
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DOI: 10.1002/bit.28118
Abstract: In this study, we present the first integrated and continuous downstream process for the production of microbial virus‐like particle vaccines. Modular murine polyomavirus major capsid VP1 with integrated J8 antigen was used as a model… read more here.
Keywords: continuous downstream; process; downstream process; integrated continuous ... See more keywords
Integrated continuous biomanufacturing on pilot scale for acid-sensitive monoclonal antibodies.
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DOI: 10.1002/bit.28120
Abstract: In this study, we demonstrated the first, to our knowledge, integrated continuous bioprocess (ICB) designed for the production of acid-sensitive monoclonal antibodies, prone to aggregate at low pH, on pilot scale. A high cell density… read more here.
Keywords: pilot scale; acid sensitive; monoclonal antibodies; integrated continuous ... See more keywords
Process design of a fully integrated continuous biopharmaceutical process using economic and ecological impact assessment
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DOI: 10.1002/bit.28234
Abstract: Continuous biomanufacturing is a promising alternative to current batch operation as it offers benefits in terms of improved productivity, product quality, and reduced footprint. This study aims to build a fully integrated continuous platform for… read more here.
Keywords: fully integrated; process design; bioreactor scale; economic ecological ... See more keywords