Model‐Based Process Development in the Biopharmaceutical Industry
This chapter presents an example of how mechanistic modeling may be applied in the biopharmaceutical industry. It shows how the different quality by design (QbD) elements of risk assessment and process knowledge are linked through identification of key critical quality attributes (CQAs), which may b...
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| Vydáno v: | Preparative Chromatography for Separation of Proteins s. 429 - 455 |
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| Hlavní autoři: | , , , , |
| Médium: | Kapitola |
| Jazyk: | angličtina |
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United States
John Wiley & Sons, Incorporated
2017
John Wiley & Sons, Inc |
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| ISBN: | 1119031109, 9781119031109 |
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| Abstract | This chapter presents an example of how mechanistic modeling may be applied in the biopharmaceutical industry. It shows how the different quality by design (QbD) elements of risk assessment and process knowledge are linked through identification of key critical quality attributes (CQAs), which may be affected by the step and the different process parameters responsible for such influence on the CQAs. The chapter contains examples of MATLAB programming code, which can be directly implemented for modeling of size exclusion chromatography (SEC). FVIII is one of the most complex recombinant proteins that has been produced, and as such it may be regarded as a highly complicated molecule to be subject to process modeling. Given the fragile nature of FVIII molecules, a considerate purification process is needed after serum‐free (SF) cultivation. The turoctocog alfa process case study demonstrates that by only a few calibration experiments, a useful model can be established. |
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| AbstractList | This chapter presents an example of how mechanistic modeling may be applied in the biopharmaceutical industry. It shows how the different quality by design (QbD) elements of risk assessment and process knowledge are linked through identification of key critical quality attributes (CQAs), which may be affected by the step and the different process parameters responsible for such influence on the CQAs. The chapter contains examples of MATLAB programming code, which can be directly implemented for modeling of size exclusion chromatography (SEC). FVIII is one of the most complex recombinant proteins that has been produced, and as such it may be regarded as a highly complicated molecule to be subject to process modeling. Given the fragile nature of FVIII molecules, a considerate purification process is needed after serum‐free (SF) cultivation. The turoctocog alfa process case study demonstrates that by only a few calibration experiments, a useful model can be established. |
| Author | Ahmadian, Haleh Sejergaard, Lars Hansen, Thomas B. Staby, Arne Hansen, Ernst B. |
| Author_xml | – sequence: 1 givenname: Lars surname: Sejergaard fullname: Sejergaard, Lars organization: Mathematical Modelling, Novo Nordisk A/S – sequence: 2 givenname: Haleh surname: Ahmadian fullname: Ahmadian, Haleh organization: Protein Purification Technology, Novo Nordisk A/S – sequence: 3 givenname: Thomas B. surname: Hansen fullname: Hansen, Thomas B. organization: Mathematical Modelling, Novo Nordisk A/S – sequence: 4 givenname: Arne surname: Staby fullname: Staby, Arne organization: CMC Project Planning & Management, Novo Nordisk A/S – sequence: 5 givenname: Ernst B. surname: Hansen fullname: Hansen, Ernst B. organization: Mathematical Modelling, Novo Nordisk A/S |
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| Copyright | 2017 John Wiley & Sons, Inc. |
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| Editor | Staby, Arne Rathore, Anurag S Ahuja, Satinder |
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| References | Nilsson, Borgquist, Axelsson, Zacchi (c14-cit-0009) 1999; 23 Svensson, Thim, Olsen, Nicolaisen (c14-cit-0006) 2013; 394 Burke, Pachl, Quiroga, Rosenberg, Haigwood, Nordfang, Ezban (c14-cit-0007) 1986; 261 Degerman, Hansen, Sejergaard, Hansen, Krarup, Frederiksen, Kidal, Staby (c14-cit-0008) 2011 Jakobsson, Karlsson, Axelsson, Zacchi, Nilsson (c14-cit-0002) 2005; 1063 Vehar, Keyt, Eaton, Rodriguez, O'Brien, Rotblat (c14-cit-0004) 1984; 312 Gitschier, Wood, Goralka, Wion, Chen, Eaton (c14-cit-0003) 1984; 312 Kaufman, Wasley, Dorner (c14-cit-0005) 1988; 263 Nilsson, Borgquist, Persson (c14-cit-0010) 1999 Zelic, Nesek (c14-cit-0001) 2006; 6 |
| References_xml | – volume: 263 start-page: 6352 year: 1988 end-page: 6362 ident: c14-cit-0005 publication-title: J. Biol. Chem. – volume: 312 start-page: 326 year: 1984 end-page: 330 ident: c14-cit-0003 publication-title: Nature – volume: 261 start-page: 12574 issue: 27 year: 1986 end-page: 12578 ident: c14-cit-0007 publication-title: J. Biol. Chem – volume: 6 start-page: 163 issue: 2 year: 2006 end-page: 169 ident: c14-cit-0001 publication-title: Eng. Life Sci. – volume: 1063 start-page: 99 year: 2005 end-page: 109 ident: c14-cit-0002 publication-title: J. Chromatogr. A – volume: 23 start-page: S715 year: 1999 end-page: S718 ident: c14-cit-0009 publication-title: Comput. Chem. Eng. – year: 1999 ident: c14-cit-0010 article-title: A Simulator for Multi Component Chromatography publication-title: Preprints of SIMS 99 – volume: 394 start-page: 761 year: 2013 end-page: 765 ident: c14-cit-0006 publication-title: Biol. Chem. – volume: 312 start-page: 337 year: 1984 end-page: 342 ident: c14-cit-0004 publication-title: Nature – year: 2011 ident: c14-cit-0008 article-title: Model based process development in biopharmaceutical industry—case studies |
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| Snippet | This chapter presents an example of how mechanistic modeling may be applied in the biopharmaceutical industry. It shows how the different quality by design... |
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| SubjectTerms | BIOLOGY, LIFE SCIENCES biopharmaceutical industry Chemical engineering CHEMISTRY critical quality attributes exclusion chromatography FVIII gene MATLAB programming code model‐based process development quality by design turoctocog alfa process |
| Title | Model‐Based Process Development in the Biopharmaceutical Industry |
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