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Bioreactor Expansion of Human Mesenchymal Stem Cells According to GMP Requirements

  • Christiane L. Elseberg
  • Denise Salzig
  • Peter Czermak
Protocol
Part of the Methods in Molecular Biology book series (MIMB, volume 1283)

Abstract

In cell therapy, the use of autologous and allogenic human mesenchymal stem cells is rising. Accordingly, the supply of cells for clinical applications in highest quality is required. As hMSCs are considered as an advanced therapy medicinal products (ATMP), they underlie the requirements of GMP and PAT according to the authorities (FDA and EMA). The production process of these cells must therefore be documented according to GMP, which is usually performed via a GMP protocol based on standard operating procedures. This chapter provides an example of such a GMP protocol for hMSC, here a genetically modified allogenic cell line, based on a production process in a microcarrier-based stirred tank reactor including process monitoring according to PAT and final product quality assurance.

Keywords:

hMSC GMP protocol SOP PAT Authorities 

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Christiane L. Elseberg
    • 1
  • Denise Salzig
    • 1
  • Peter Czermak
    • 1
    • 2
    • 3
  1. 1.Institute of Bioprocess Engineering and Pharmaceutical TechnologyUniversity of Applied Sciences MittelhessenGiessenGermany
  2. 2.Department of Chemical EngineeringFaculty of Engineering, Kansas State UniversityManhattanUSA
  3. 3.Faculty of Biology and ChemistryJustus-Liebig-University GiessenGiessenGermany

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