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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Bibliographic Details
Published in:Preparative Chromatography for Separation of Proteins pp. 429 - 455
Main Authors: Sejergaard, Lars, Ahmadian, Haleh, Hansen, Thomas B., Staby, Arne, Hansen, Ernst B.
Format: Book Chapter
Language:English
Published: United States John Wiley & Sons, Incorporated 2017
John Wiley & Sons, Inc
Subjects:
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
ISBN:1119031109, 9781119031109
Online Access:Get full text
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Summary: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.
ISBN:1119031109
9781119031109
DOI:10.1002/9781119031116.ch14