In-line monitoring of surfactant clearance in viral vaccine downstream processing
Purpose: The goal of this study is to examine the suitability of in-line infrared measurements to monitor, in real-time, surfactant concentration in the viral vaccine drug substance during a 50KDa tangential flow filtration (TFF) process. Methods: A ReactIR™ 702L instrument was used to gather spectr...
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doaj-bbb27a524ee64b8e91d402490b4aad812021-04-08T04:18:50ZengElsevierComputational and Structural Biotechnology Journal2001-03702021-01-011918291837In-line monitoring of surfactant clearance in viral vaccine downstream processingJessie Payne0James Cronin1Manjit Haer2Jason Krouse3William Prosperi4Katherine Drolet-Vives5Matthew Lieve6Michael Soika7Matthew Balmer8Marina Kirkitadze9Analytical Sciences, Sanofi Pasteur, Toronto, Canada; Queen's University, Kingston, CanadaMettler Toledo AutoChem Inc., Columbia, USAAnalytical Sciences, Sanofi Pasteur, Toronto, CanadaManufacturing Technology, Sanofi Pasteur, Swiftwater, USAManufacturing Technology, Sanofi Pasteur, Swiftwater, USAMettler Toledo AutoChem Inc., Columbia, USAViral Manufacturing, Industrial Affairs, Sanofi Pasteur, Swiftwater, USAManufacturing Technology, Sanofi Pasteur, Swiftwater, USAAnalytical Sciences, Sanofi Pasteur, Toronto, Canada; Analytical Sciences, Sanofi Pasteur, Swiftwater, USAAnalytical Sciences, Sanofi Pasteur, Toronto, Canada; Corresponding author.Purpose: The goal of this study is to examine the suitability of in-line infrared measurements to monitor, in real-time, surfactant concentration in the viral vaccine drug substance during a 50KDa tangential flow filtration (TFF) process. Methods: A ReactIR™ 702L instrument was used to gather spectra of process off-line samples and reference materials to assess the feasibility of monitoring surfactant concentration during a TFF process in real-time. Both univariate and multivariate models were used to evaluate the off-line sample data and were found to be in good agreement with surfactant concentration values obtained by HPLC. These results were used as justification for a real-time TFF experiment with live process material. Results: Small scale ReactIR experiments with process material demonstrated that a multivariate model using the 1300 cm−1 to 1000 cm−1 spectral region can be used to predict surfactant concentrations between TFF exchanges 8 to 15. Conclusion: The results of this study demonstrated suitability of an in-line infrared measurement to monitor surfactant concentration in the viral vaccine drug substance between exchanges 8–15 of a 50 kDa tangential flow filtration process. The preliminary multivariate model used for this work can be further optimized for the in-line use at manufacturing scale.http://www.sciencedirect.com/science/article/pii/S2001037021001021Viral vaccineResidualsIRReactIRPATClearance |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jessie Payne James Cronin Manjit Haer Jason Krouse William Prosperi Katherine Drolet-Vives Matthew Lieve Michael Soika Matthew Balmer Marina Kirkitadze |
spellingShingle |
Jessie Payne James Cronin Manjit Haer Jason Krouse William Prosperi Katherine Drolet-Vives Matthew Lieve Michael Soika Matthew Balmer Marina Kirkitadze In-line monitoring of surfactant clearance in viral vaccine downstream processing Computational and Structural Biotechnology Journal Viral vaccine Residuals IR ReactIR PAT Clearance |
author_facet |
Jessie Payne James Cronin Manjit Haer Jason Krouse William Prosperi Katherine Drolet-Vives Matthew Lieve Michael Soika Matthew Balmer Marina Kirkitadze |
author_sort |
Jessie Payne |
title |
In-line monitoring of surfactant clearance in viral vaccine downstream processing |
title_short |
In-line monitoring of surfactant clearance in viral vaccine downstream processing |
title_full |
In-line monitoring of surfactant clearance in viral vaccine downstream processing |
title_fullStr |
In-line monitoring of surfactant clearance in viral vaccine downstream processing |
title_full_unstemmed |
In-line monitoring of surfactant clearance in viral vaccine downstream processing |
title_sort |
in-line monitoring of surfactant clearance in viral vaccine downstream processing |
publisher |
Elsevier |
series |
Computational and Structural Biotechnology Journal |
issn |
2001-0370 |
publishDate |
2021-01-01 |
description |
Purpose: The goal of this study is to examine the suitability of in-line infrared measurements to monitor, in real-time, surfactant concentration in the viral vaccine drug substance during a 50KDa tangential flow filtration (TFF) process. Methods: A ReactIR™ 702L instrument was used to gather spectra of process off-line samples and reference materials to assess the feasibility of monitoring surfactant concentration during a TFF process in real-time. Both univariate and multivariate models were used to evaluate the off-line sample data and were found to be in good agreement with surfactant concentration values obtained by HPLC. These results were used as justification for a real-time TFF experiment with live process material. Results: Small scale ReactIR experiments with process material demonstrated that a multivariate model using the 1300 cm−1 to 1000 cm−1 spectral region can be used to predict surfactant concentrations between TFF exchanges 8 to 15. Conclusion: The results of this study demonstrated suitability of an in-line infrared measurement to monitor surfactant concentration in the viral vaccine drug substance between exchanges 8–15 of a 50 kDa tangential flow filtration process. The preliminary multivariate model used for this work can be further optimized for the in-line use at manufacturing scale. |
topic |
Viral vaccine Residuals IR ReactIR PAT Clearance |
url |
http://www.sciencedirect.com/science/article/pii/S2001037021001021 |
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1721535550393942016 |