Economic analysis of buffer preparation strategy for single-use bioprocessing of monoclonal antibodies

The total cost of buffer preparation was analyzed for an existing single-use mAbs downstream processing facility. The cost effectiveness of outsourcing the liquid buffer as a ready-to-use and/or concentrate was examined by comparing a traditional made-in-house buffer from solid ingredients. The anal...

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Main Authors: Takao ITO, Ann-Kathrin Uebele, Takashi Nihei, Koichi Yamamoto, Naoto Watanabe, Yoshiyuki Tokieda, Masaki Okada
Format: Article
Language:English
Published: Elsevier 2024-11-01
Series:EFB Bioeconomy Journal
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Online Access:http://www.sciencedirect.com/science/article/pii/S266704102400003X
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author Takao ITO
Ann-Kathrin Uebele
Takashi Nihei
Koichi Yamamoto
Naoto Watanabe
Yoshiyuki Tokieda
Masaki Okada
author_facet Takao ITO
Ann-Kathrin Uebele
Takashi Nihei
Koichi Yamamoto
Naoto Watanabe
Yoshiyuki Tokieda
Masaki Okada
author_sort Takao ITO
collection DOAJ
description The total cost of buffer preparation was analyzed for an existing single-use mAbs downstream processing facility. The cost effectiveness of outsourcing the liquid buffer as a ready-to-use and/or concentrate was examined by comparing a traditional made-in-house buffer from solid ingredients. The analysis show the combination of made-in-house buffer and concentrate buffer provides the greatest cost advantages. Ready-to-use buffers are more effective for improved facility footprint and provide cost benefits when in-house labor and consumables exceeds the cost of outsourcing. From the calculation of the cost of labor and number of pallets, although the difference in labor costs was small between the various buffer preparation methods, the use of concentrated buffers reduced both the total number of pallets and overall costs. When a new in-line dilution system is installed, a high facility utilization rate of at least ten preparations per year is required to leverage the cost savings from single-use consumables.
format Article
id doaj-art-fe9fce1aa0b546b281f27078befeaaa5
institution Kabale University
issn 2667-0410
language English
publishDate 2024-11-01
publisher Elsevier
record_format Article
series EFB Bioeconomy Journal
spelling doaj-art-fe9fce1aa0b546b281f27078befeaaa52024-11-18T04:33:57ZengElsevierEFB Bioeconomy Journal2667-04102024-11-014100065Economic analysis of buffer preparation strategy for single-use bioprocessing of monoclonal antibodiesTakao ITO0Ann-Kathrin Uebele1Takashi Nihei2Koichi Yamamoto3Naoto Watanabe4Yoshiyuki Tokieda5Masaki Okada6Merck Ltd. (An Affiliate of Merck KGaA, Darmstadt, Germany), Tokyo Japan; Corresponding author.Merck KgaA, Darmstadt, GermanyTakeda Pharmaceutical Co., Ltd., Fujisawa JapanKyowa Kirin Co., Ltd., Takasaki JapanAsahi Kasei Medical Co., Ltd., Tokyo JapanKM Biologics Co., Ltd. Kikuchi JapanLife Scientia Ltd., Yokohama JapanThe total cost of buffer preparation was analyzed for an existing single-use mAbs downstream processing facility. The cost effectiveness of outsourcing the liquid buffer as a ready-to-use and/or concentrate was examined by comparing a traditional made-in-house buffer from solid ingredients. The analysis show the combination of made-in-house buffer and concentrate buffer provides the greatest cost advantages. Ready-to-use buffers are more effective for improved facility footprint and provide cost benefits when in-house labor and consumables exceeds the cost of outsourcing. From the calculation of the cost of labor and number of pallets, although the difference in labor costs was small between the various buffer preparation methods, the use of concentrated buffers reduced both the total number of pallets and overall costs. When a new in-line dilution system is installed, a high facility utilization rate of at least ten preparations per year is required to leverage the cost savings from single-use consumables.http://www.sciencedirect.com/science/article/pii/S266704102400003XConcentrated bufferReady-to-use bufferDownstream processingMonoclonal antibodyIn-line dilution
spellingShingle Takao ITO
Ann-Kathrin Uebele
Takashi Nihei
Koichi Yamamoto
Naoto Watanabe
Yoshiyuki Tokieda
Masaki Okada
Economic analysis of buffer preparation strategy for single-use bioprocessing of monoclonal antibodies
EFB Bioeconomy Journal
Concentrated buffer
Ready-to-use buffer
Downstream processing
Monoclonal antibody
In-line dilution
title Economic analysis of buffer preparation strategy for single-use bioprocessing of monoclonal antibodies
title_full Economic analysis of buffer preparation strategy for single-use bioprocessing of monoclonal antibodies
title_fullStr Economic analysis of buffer preparation strategy for single-use bioprocessing of monoclonal antibodies
title_full_unstemmed Economic analysis of buffer preparation strategy for single-use bioprocessing of monoclonal antibodies
title_short Economic analysis of buffer preparation strategy for single-use bioprocessing of monoclonal antibodies
title_sort economic analysis of buffer preparation strategy for single use bioprocessing of monoclonal antibodies
topic Concentrated buffer
Ready-to-use buffer
Downstream processing
Monoclonal antibody
In-line dilution
url http://www.sciencedirect.com/science/article/pii/S266704102400003X
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