Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Motevalian, Seyed Pouria, Steen, Jonathan, De Leon, Janine, Sriskanda, Verl, Carino, Ivette, Prashad, Amar S., Carrillo Conde, Brenda, Arve, Bo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2021
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
_version_ 1784747861092597760
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
work_keys_str_mv AT motevalianseyedpouria evaluationofsingleusetangentialflowfiltrationtechnologyforpurificationofactivatedpolysaccharidesusedinconjugatevaccinemanufacturing
AT steenjonathan evaluationofsingleusetangentialflowfiltrationtechnologyforpurificationofactivatedpolysaccharidesusedinconjugatevaccinemanufacturing
AT deleonjanine evaluationofsingleusetangentialflowfiltrationtechnologyforpurificationofactivatedpolysaccharidesusedinconjugatevaccinemanufacturing
AT sriskandaverl evaluationofsingleusetangentialflowfiltrationtechnologyforpurificationofactivatedpolysaccharidesusedinconjugatevaccinemanufacturing
AT carinoivette evaluationofsingleusetangentialflowfiltrationtechnologyforpurificationofactivatedpolysaccharidesusedinconjugatevaccinemanufacturing
AT prashadamars evaluationofsingleusetangentialflowfiltrationtechnologyforpurificationofactivatedpolysaccharidesusedinconjugatevaccinemanufacturing
AT carrillocondebrenda evaluationofsingleusetangentialflowfiltrationtechnologyforpurificationofactivatedpolysaccharidesusedinconjugatevaccinemanufacturing
AT arvebo evaluationofsingleusetangentialflowfiltrationtechnologyforpurificationofactivatedpolysaccharidesusedinconjugatevaccinemanufacturing