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Lifecycle Management for Recombinant Protein Production Using Mammalian Cell Culture Technology

Part of the Advances in Biochemical Engineering/Biotechnology book series (ABE,volume 139)

Keywords

  • Cell culture technology
  • Post-approval changes
  • Technology lifecycle management

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  • DOI: 10.1007/10_2013_258
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  4. ICH Q5E: comparability of biotechnological/biological products subject to changes in their manufacturing process

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  5. Looby M, Ibarra N, Pierce J, Buckley K, O’Donovan E, Heenan M, Moran E, Farid S, Baganz, F (2011) Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein. Biotechnol Prog 27(6):1718–1729

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Correspondence to Enda Moran .

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Moran, E., Gammell, P. (2013). Lifecycle Management for Recombinant Protein Production Using Mammalian Cell Culture Technology. In: Zhou, W., Kantardjieff, A. (eds) Mammalian Cell Cultures for Biologics Manufacturing. Advances in Biochemical Engineering/Biotechnology, vol 139. Springer, Berlin, Heidelberg. https://doi.org/10.1007/10_2013_258

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