In‐line monitoring of protein concentration with MIR spectroscopy during UFDF

Abstract Rapid increase of product titers in upstream processes has presented challenges for downstream processing, where purification costs increase linearly with the increase of the product yield. Hence, innovative solutions are becoming increasingly popular. Process Analytical Technology (PAT) to...

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Main Authors: Adrianna Milewska, Géraldine Baekelandt, Sarra Boutaieb, Vitalii Mozin, Andrew Falconbridge
Format: Article
Language:English
Published: Wiley-VCH 2023-02-01
Series:Engineering in Life Sciences
Subjects:
Online Access:https://doi.org/10.1002/elsc.202200050
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author Adrianna Milewska
Géraldine Baekelandt
Sarra Boutaieb
Vitalii Mozin
Andrew Falconbridge
author_facet Adrianna Milewska
Géraldine Baekelandt
Sarra Boutaieb
Vitalii Mozin
Andrew Falconbridge
author_sort Adrianna Milewska
collection DOAJ
description Abstract Rapid increase of product titers in upstream processes has presented challenges for downstream processing, where purification costs increase linearly with the increase of the product yield. Hence, innovative solutions are becoming increasingly popular. Process Analytical Technology (PAT) tools, such as spectroscopic techniques, are on the rise due to their capacity to provide real‐time, precise analytics. This ensures consistent product quality and increased process understanding, as well as process control. Mid‐infrared spectroscopy (MIR) has emerged as a highly promising technique within recent years, owing to its ability to monitor several critical process parameters at the same time and unchallenging spectral analysis and data interpretation. For in‐line monitoring, Attenuated Total Reflectance—Fourier Transform Infrared Spectroscopy (ATR‐FTIR) is a method of choice, as it enables reliable measurements in a liquid environment, even though water absorption bands are present in the region of interest. Here, we present MIR spectroscopy as a monitoring tool of critical process parameters in ultrafiltration/diafiltration (UFDF). MIR spectrometer was integrated in the UFDF process in an in‐line fashion through a single‐use flow cell containing a single bounce silicon ATR crystal. The results indicate that the one‐point calibration algorithm applied to the MIR spectra, predicts highly accurate protein concentrations, as compared with validated offline analytical methods.
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spelling doaj.art-9cb1109dac9c46208f9596649a3fb6a82023-02-02T13:23:42ZengWiley-VCHEngineering in Life Sciences1618-02401618-28632023-02-01232n/an/a10.1002/elsc.202200050In‐line monitoring of protein concentration with MIR spectroscopy during UFDFAdrianna Milewska0Géraldine Baekelandt1Sarra Boutaieb2Vitalii Mozin3Andrew Falconbridge4Alvotech Reykjavík IcelandIRUBIS GmbH München GermanyIRUBIS GmbH München GermanyIRUBIS GmbH München GermanyAlvotech Reykjavík IcelandAbstract Rapid increase of product titers in upstream processes has presented challenges for downstream processing, where purification costs increase linearly with the increase of the product yield. Hence, innovative solutions are becoming increasingly popular. Process Analytical Technology (PAT) tools, such as spectroscopic techniques, are on the rise due to their capacity to provide real‐time, precise analytics. This ensures consistent product quality and increased process understanding, as well as process control. Mid‐infrared spectroscopy (MIR) has emerged as a highly promising technique within recent years, owing to its ability to monitor several critical process parameters at the same time and unchallenging spectral analysis and data interpretation. For in‐line monitoring, Attenuated Total Reflectance—Fourier Transform Infrared Spectroscopy (ATR‐FTIR) is a method of choice, as it enables reliable measurements in a liquid environment, even though water absorption bands are present in the region of interest. Here, we present MIR spectroscopy as a monitoring tool of critical process parameters in ultrafiltration/diafiltration (UFDF). MIR spectrometer was integrated in the UFDF process in an in‐line fashion through a single‐use flow cell containing a single bounce silicon ATR crystal. The results indicate that the one‐point calibration algorithm applied to the MIR spectra, predicts highly accurate protein concentrations, as compared with validated offline analytical methods.https://doi.org/10.1002/elsc.202200050bioprocessingdownstream bioprocessingmid‐infrared spectroscopyprocess analytical technology
spellingShingle Adrianna Milewska
Géraldine Baekelandt
Sarra Boutaieb
Vitalii Mozin
Andrew Falconbridge
In‐line monitoring of protein concentration with MIR spectroscopy during UFDF
Engineering in Life Sciences
bioprocessing
downstream bioprocessing
mid‐infrared spectroscopy
process analytical technology
title In‐line monitoring of protein concentration with MIR spectroscopy during UFDF
title_full In‐line monitoring of protein concentration with MIR spectroscopy during UFDF
title_fullStr In‐line monitoring of protein concentration with MIR spectroscopy during UFDF
title_full_unstemmed In‐line monitoring of protein concentration with MIR spectroscopy during UFDF
title_short In‐line monitoring of protein concentration with MIR spectroscopy during UFDF
title_sort in line monitoring of protein concentration with mir spectroscopy during ufdf
topic bioprocessing
downstream bioprocessing
mid‐infrared spectroscopy
process analytical technology
url https://doi.org/10.1002/elsc.202200050
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AT vitaliimozin inlinemonitoringofproteinconcentrationwithmirspectroscopyduringufdf
AT andrewfalconbridge inlinemonitoringofproteinconcentrationwithmirspectroscopyduringufdf