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Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step

One of the key challenges in downstream bioprocessing is to obtain products of high purity in a productive fashion through the effective removal of process and product related impurities. While a classical simulated moving bed (SMB) system operation can typically achieve a 2-component separation bet...

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Autores principales: Chen, Serene W., Zheng, Zi Ying, Mahfut, Farouq Bin, Yang, Yuansheng, Ogino, Masahiro, Okada, Kazuo, Sato, Kohei, Zhang, Wei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9876269/
https://www.ncbi.nlm.nih.gov/pubmed/36696419
http://dx.doi.org/10.1371/journal.pone.0280760
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author Chen, Serene W.
Zheng, Zi Ying
Mahfut, Farouq Bin
Yang, Yuansheng
Ogino, Masahiro
Okada, Kazuo
Sato, Kohei
Zhang, Wei
author_facet Chen, Serene W.
Zheng, Zi Ying
Mahfut, Farouq Bin
Yang, Yuansheng
Ogino, Masahiro
Okada, Kazuo
Sato, Kohei
Zhang, Wei
author_sort Chen, Serene W.
collection PubMed
description One of the key challenges in downstream bioprocessing is to obtain products of high purity in a productive fashion through the effective removal of process and product related impurities. While a classical simulated moving bed (SMB) system operation can typically achieve a 2-component separation between the weakly bound impurities and target species, here we present an advanced SMB approach that can achieve a 3-component separation, including the removal of the strongly bound impurities from the target species. As a proof-of-concept, we demonstrate the enhanced removal of strongly bound host cell proteins (HCP) from the target monoclonal antibody (mAb) through the utilisation of the advanced SMB approach in a non-affinity cation exchange (CEX) capture step. In this way, 1 less polishing step was required to achieve the therapeutic requirements of < 100 ppm HCP and the overall process recovery was increased by ~ 6% compared to the corresponding process that utilised a batch CEX operation. The non-affinity CEX capture platform technology established through the utilisation of the advanced SMB approach presented here can potentially be further applied to address the downstream processing challenges presented by other challenging biotherapeutic modalities to yield a final target product with improved purity and recovery.
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spelling pubmed-98762692023-01-26 Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step Chen, Serene W. Zheng, Zi Ying Mahfut, Farouq Bin Yang, Yuansheng Ogino, Masahiro Okada, Kazuo Sato, Kohei Zhang, Wei PLoS One Research Article One of the key challenges in downstream bioprocessing is to obtain products of high purity in a productive fashion through the effective removal of process and product related impurities. While a classical simulated moving bed (SMB) system operation can typically achieve a 2-component separation between the weakly bound impurities and target species, here we present an advanced SMB approach that can achieve a 3-component separation, including the removal of the strongly bound impurities from the target species. As a proof-of-concept, we demonstrate the enhanced removal of strongly bound host cell proteins (HCP) from the target monoclonal antibody (mAb) through the utilisation of the advanced SMB approach in a non-affinity cation exchange (CEX) capture step. In this way, 1 less polishing step was required to achieve the therapeutic requirements of < 100 ppm HCP and the overall process recovery was increased by ~ 6% compared to the corresponding process that utilised a batch CEX operation. The non-affinity CEX capture platform technology established through the utilisation of the advanced SMB approach presented here can potentially be further applied to address the downstream processing challenges presented by other challenging biotherapeutic modalities to yield a final target product with improved purity and recovery. Public Library of Science 2023-01-25 /pmc/articles/PMC9876269/ /pubmed/36696419 http://dx.doi.org/10.1371/journal.pone.0280760 Text en © 2023 Chen et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Chen, Serene W.
Zheng, Zi Ying
Mahfut, Farouq Bin
Yang, Yuansheng
Ogino, Masahiro
Okada, Kazuo
Sato, Kohei
Zhang, Wei
Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step
title Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step
title_full Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step
title_fullStr Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step
title_full_unstemmed Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step
title_short Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step
title_sort leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9876269/
https://www.ncbi.nlm.nih.gov/pubmed/36696419
http://dx.doi.org/10.1371/journal.pone.0280760
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