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Anion Exchange Chromatography Provides a Robust, Predictable Process to Ensure Viral Safety of Biotechnology Products by Daniel M. Strauss; Jeffrey Gorrell; Magdalena Plancarte; Gregory S. Blank; Qi Chen; Bin Yang is a Biochemistry, Genetics and Molecular Biology article available to read on EtoBox.
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## Abstract The mammalian cell‐lines used to produce biopharmaceutical products are known to produce endogenous retrovirus‐like particles and have the potential to foster adventitious viruses as well. To ensure product safety and regulatory compliance, recovery processes must be capable of removing or inactivating any viral impurities or contaminants which may be present. Anion exchange chromatography (AEX) is a common process in the recovery of monoclonal antibody products and has been shown to be effective for viral removal. To further characterize the robustness of viral clearance by AEX with respect to process variations, we have investigated the ability of an AEX process to remove three model viruses using various combinations of mAb products, feedstock conductivities and compositions, equilibration buffers, and pooling criteria. Our data indicate that AEX provides complete or near‐complete removal of all three model viruses over a wide range of process conditions, including those typically used in manufacturing processes. Furthermore, this process provides effective viral clearance for different mAb products, using a variety of feedstocks, equilibration buffers, and different
Who reads Anion Exchange Chromatography Provides a Robust, Predictable Process to Ensure Viral Safety of Biotechnology Products?
It is typically read by researchers, students, and practitioners in Biochemistry, Genetics and Molecular Biology.
- Author
- Daniel M. Strauss; Jeffrey Gorrell; Magdalena Plancarte; Gregory S. Blank; Qi Chen; Bin Yang
- Publisher
- John Wiley and Sons; Wiley (John Wiley & Sons); Wiley - V C H Verlag GmbbH & Co.; Wiley (ISSN 0006-3592)
- Published
- 2008
- Language
- EN
- Field
- Biochemistry, Genetics and Molecular Biology (Life Sciences)