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Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing
Over the past decade, single‐use tangential flow filtration (TFF) technologies have emerged to reduce system preparation time, promote fast and flexible product change over, and ultimately shorten process development and manufacturing time/cost. In this study, the performance of a recently developed...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9285785/ https://www.ncbi.nlm.nih.gov/pubmed/34459567 http://dx.doi.org/10.1002/btpr.3204 |
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author | Motevalian, Seyed Pouria Steen, Jonathan De Leon, Janine Sriskanda, Verl Carino, Ivette Prashad, Amar S. Carrillo Conde, Brenda Arve, Bo |
author_facet | Motevalian, Seyed Pouria Steen, Jonathan De Leon, Janine Sriskanda, Verl Carino, Ivette Prashad, Amar S. Carrillo Conde, Brenda Arve, Bo |
author_sort | Motevalian, Seyed Pouria |
collection | PubMed |
description | Over the past decade, single‐use tangential flow filtration (TFF) technologies have emerged to reduce system preparation time, promote fast and flexible product change over, and ultimately shorten process development and manufacturing time/cost. In this study, the performance of a recently developed Pellicon® single‐use TFF capsule was compared against traditional Pellicon® cassettes by assessing TFF process performance (such as flux, residuals clearance, and yield) and post‐purification product attributes (such as concentration and mass‐weighted average molecular weight). Good scaling was shown by comparing process performance and product attributes across different scales and formats. Additionally, similar TFF process performance and post‐purification product attributes were observed for the single‐use capsule compared to the reusable TFF cassettes. The capsule requires a smaller flush than the cassette, and it is easier to use since it does not require a compression holder or pre‐sanitization. The results provide insight into the application of the single‐use TFF capsule and scalability of TFF processes for the purification of conjugate vaccines. |
format | Online Article Text |
id | pubmed-9285785 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92857852022-07-18 Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing Motevalian, Seyed Pouria Steen, Jonathan De Leon, Janine Sriskanda, Verl Carino, Ivette Prashad, Amar S. Carrillo Conde, Brenda Arve, Bo Biotechnol Prog RESEARCH ARTICLES Over the past decade, single‐use tangential flow filtration (TFF) technologies have emerged to reduce system preparation time, promote fast and flexible product change over, and ultimately shorten process development and manufacturing time/cost. In this study, the performance of a recently developed Pellicon® single‐use TFF capsule was compared against traditional Pellicon® cassettes by assessing TFF process performance (such as flux, residuals clearance, and yield) and post‐purification product attributes (such as concentration and mass‐weighted average molecular weight). Good scaling was shown by comparing process performance and product attributes across different scales and formats. Additionally, similar TFF process performance and post‐purification product attributes were observed for the single‐use capsule compared to the reusable TFF cassettes. The capsule requires a smaller flush than the cassette, and it is easier to use since it does not require a compression holder or pre‐sanitization. The results provide insight into the application of the single‐use TFF capsule and scalability of TFF processes for the purification of conjugate vaccines. John Wiley & Sons, Inc. 2021-09-21 2021 /pmc/articles/PMC9285785/ /pubmed/34459567 http://dx.doi.org/10.1002/btpr.3204 Text en © 2021 Pfizer Inc and EMD Millipore Corporation. Biotechnology Progress published by Wiley Periodicals LLC on behalf of American Institute of Chemical Engineers. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | RESEARCH ARTICLES Motevalian, Seyed Pouria Steen, Jonathan De Leon, Janine Sriskanda, Verl Carino, Ivette Prashad, Amar S. Carrillo Conde, Brenda Arve, Bo Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing |
title | Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing |
title_full | Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing |
title_fullStr | Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing |
title_full_unstemmed | Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing |
title_short | Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing |
title_sort | evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing |
topic | RESEARCH ARTICLES |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9285785/ https://www.ncbi.nlm.nih.gov/pubmed/34459567 http://dx.doi.org/10.1002/btpr.3204 |
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