Addressing the Challenges in Downstream Processing Today and Tomorrow
In recent years, most pharmaceutical companies have focused on the development of monoclonal antibodies (mAbs). Increasing upstream titers and shrinking development timelines have posed several challenges to downstream process development of mAbs. Some of the major strategies and tools to address th...
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| Veröffentlicht in: | Biopharm International 2011-04, p.S8 |
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| creator | Bolton, Glen R Violand, Bernard N Wright, Richard S Sun, Shujun Sunasara, Khurram M Watson, Kathleen Coffman, Jonathan L Gallo, Christopher Godavarti, Ranga |
| description | In recent years, most pharmaceutical companies have focused on the development of monoclonal antibodies (mAbs). Increasing upstream titers and shrinking development timelines have posed several challenges to downstream process development of mAbs. Some of the major strategies and tools to address these challenges include the development of highly efficient platforms, high-throughput screening (HTS) tools, and reduction of the number of unit operations to help with facility fit. In the future, mAbs may represent a smaller percentage of the pipeline as portfolios concentrate more on development of antibody fragments, nanobodies, biosimilar protein therapeutics, conjugated proteins and vaccines, Fc-fusions, and nonantibody protein scaffolds. In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of BioTx and expression systems will pose unique challenges for downstream development. Novel tools, approaches, and/or platforms will be required to enable rapid development. Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx. [PUBLICATION ABSTRACT] |
| format | Magazinearticle |
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Increasing upstream titers and shrinking development timelines have posed several challenges to downstream process development of mAbs. Some of the major strategies and tools to address these challenges include the development of highly efficient platforms, high-throughput screening (HTS) tools, and reduction of the number of unit operations to help with facility fit. In the future, mAbs may represent a smaller percentage of the pipeline as portfolios concentrate more on development of antibody fragments, nanobodies, biosimilar protein therapeutics, conjugated proteins and vaccines, Fc-fusions, and nonantibody protein scaffolds. In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of BioTx and expression systems will pose unique challenges for downstream development. Novel tools, approaches, and/or platforms will be required to enable rapid development. Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx. [PUBLICATION ABSTRACT]</description><identifier>ISSN: 1542-166X</identifier><identifier>EISSN: 1939-1862</identifier><language>eng</language><publisher>Monmouth Junction: MultiMedia Healthcare Inc</publisher><subject>Biotechnology ; Cell culture ; Chromatography ; Costs ; Design of experiments ; E coli ; Manufacturing ; Methods ; Molecular weight ; Monoclonal antibodies ; Pipelines ; Proteins ; Regulatory approval ; Resins ; Studies ; Vaccines ; Yeast</subject><ispartof>Biopharm International, 2011-04, p.S8</ispartof><rights>Copyright Advanstar Communications, Inc. 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Novel tools, approaches, and/or platforms will be required to enable rapid development. Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx. 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Increasing upstream titers and shrinking development timelines have posed several challenges to downstream process development of mAbs. Some of the major strategies and tools to address these challenges include the development of highly efficient platforms, high-throughput screening (HTS) tools, and reduction of the number of unit operations to help with facility fit. In the future, mAbs may represent a smaller percentage of the pipeline as portfolios concentrate more on development of antibody fragments, nanobodies, biosimilar protein therapeutics, conjugated proteins and vaccines, Fc-fusions, and nonantibody protein scaffolds. In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of BioTx and expression systems will pose unique challenges for downstream development. Novel tools, approaches, and/or platforms will be required to enable rapid development. Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx. [PUBLICATION ABSTRACT]</abstract><cop>Monmouth Junction</cop><pub>MultiMedia Healthcare Inc</pub></addata></record> |
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| source | Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Biotechnology Cell culture Chromatography Costs Design of experiments E coli Manufacturing Methods Molecular weight Monoclonal antibodies Pipelines Proteins Regulatory approval Resins Studies Vaccines Yeast |
| title | Addressing the Challenges in Downstream Processing Today and Tomorrow |
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