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Characterizing the preparation of a concentrated nutrient feed solution for a large-scale cell culture process.

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Title: Characterizing the preparation of a concentrated nutrient feed solution for a large-scale cell culture process.
Authors: Russell, Brian1 russellb@medimmune.com, Miro-Quesada, Guillermo1, Limin, Qu1, Ahuja, Sanjeev1
Source: Biochemical Engineering Journal. Jun2018, Vol. 134, p120-128. 9p.
Subjects: Cell culture, Feed processing, Animal feeds, Feed microbiology, Bioreactors
Abstract: Fed-batch mammalian cell culture processes frequently employ concentrated and complex media and feeds during the production phase. Though significant efforts are undertaken to characterize the large-scale bioreactor with respect to its control parameters, similar efforts are not commonly undertaken to characterize the feed preparation process. During the characterization of a commercial cell culture process using elements of Quality-by-Design (QbD) principles, we identified the complex nutrient feed solution preparation as an important step and temperature, mixing time, and mixing intensity were identified as factors impacting this unit operation via a systematic risk assessment. To best simulate the large-scale feed preparation process, a 3L model was developed to determine the impact of the feed preparation conditions. Feed preparation parameters were characterized and the solutions generated were analyzed using various analytical methods, a filterability assessment, and cell culture use tests that included evaluation of culture performance and relevant product quality attributes. Based on the data from the characterization studies, appropriate ranges for an allowable multivariate operating space for large scale feed preparation were determined. These studies demonstrated how the preparation of complex nutrient feed solutions could be modeled and characterized to ensure the success of a cell culture manufacturing campaign. [ABSTRACT FROM AUTHOR]
Copyright of Biochemical Engineering Journal is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Engineering Source
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DbLabel: Engineering Source
An: 129231233
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
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  Data: Characterizing the preparation of a concentrated nutrient feed solution for a large-scale cell culture process.
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  Data: <searchLink fieldCode="AR" term="%22Russell%2C+Brian%22">Russell, Brian</searchLink><relatesTo>1</relatesTo><i> russellb@medimmune.com</i><br /><searchLink fieldCode="AR" term="%22Miro-Quesada%2C+Guillermo%22">Miro-Quesada, Guillermo</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Limin%2C+Qu%22">Limin, Qu</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Ahuja%2C+Sanjeev%22">Ahuja, Sanjeev</searchLink><relatesTo>1</relatesTo>
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  Data: <searchLink fieldCode="JN" term="%22Biochemical+Engineering+Journal%22">Biochemical Engineering Journal</searchLink>. Jun2018, Vol. 134, p120-128. 9p.
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  Data: <searchLink fieldCode="DE" term="%22Cell+culture%22">Cell culture</searchLink><br /><searchLink fieldCode="DE" term="%22Feed+processing%22">Feed processing</searchLink><br /><searchLink fieldCode="DE" term="%22Animal+feeds%22">Animal feeds</searchLink><br /><searchLink fieldCode="DE" term="%22Feed+microbiology%22">Feed microbiology</searchLink><br /><searchLink fieldCode="DE" term="%22Bioreactors%22">Bioreactors</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: Fed-batch mammalian cell culture processes frequently employ concentrated and complex media and feeds during the production phase. Though significant efforts are undertaken to characterize the large-scale bioreactor with respect to its control parameters, similar efforts are not commonly undertaken to characterize the feed preparation process. During the characterization of a commercial cell culture process using elements of Quality-by-Design (QbD) principles, we identified the complex nutrient feed solution preparation as an important step and temperature, mixing time, and mixing intensity were identified as factors impacting this unit operation via a systematic risk assessment. To best simulate the large-scale feed preparation process, a 3L model was developed to determine the impact of the feed preparation conditions. Feed preparation parameters were characterized and the solutions generated were analyzed using various analytical methods, a filterability assessment, and cell culture use tests that included evaluation of culture performance and relevant product quality attributes. Based on the data from the characterization studies, appropriate ranges for an allowable multivariate operating space for large scale feed preparation were determined. These studies demonstrated how the preparation of complex nutrient feed solutions could be modeled and characterized to ensure the success of a cell culture manufacturing campaign. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Biochemical Engineering Journal is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1016/j.bej.2018.03.009
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        Text: English
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        Type: general
      – SubjectFull: Feed processing
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      – SubjectFull: Animal feeds
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      – SubjectFull: Feed microbiology
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              Text: Jun2018
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