GMP-Compliant Expansion of Clinical-Grade Human Mesenchymal Stromal/Stem Cells Using a Closed Hollow Fiber Bioreactor.
Christina Barckhausen, Brent Rice, Stefano Baila, Luc Sensebé, Hubert Schrezenmeier, Philipp Nold, Holger Hackstein, Markus Thomas Rojewski
Author Information
Christina Barckhausen: Department of Hematology, Oncology and Immunology, University Hospital Giessen and Marburg, Philipps-University Marburg, Marburg, Germany.
Brent Rice: TerumoBCT, Lakewood, CO, USA.
Stefano Baila: TerumoBCT, Zaventem, Belgium.
Luc Sensebé: UMR5273-U1031 STROMALab, CNRS, INSERM, Université Paul Sabatier Toulouse, EFS, Toulouse, France.
Hubert Schrezenmeier: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg - Hessen, Ulm, Germany.
Philipp Nold: Department of Hematology, Oncology and Immunology, University Hospital Giessen and Marburg, Philipps-University Marburg, Marburg, Germany.
Holger Hackstein: Institute for Clinical Immunology and Transfusion Medicine, University Hospital Giessen and Marburg, Justus-Liebig-University Giessen, Giessen, Germany.
Markus Thomas Rojewski: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg - Hessen, Ulm, Germany. markus.rojewski@uni-ulm.de.
This chapter describes a method for GMP-compliant expansion of human mesenchymal stromal/stem cells (hMSC) from bone marrow aspirates, using the Quantum(®) Cell Expansion System from Terumo BCT. The Quantum system is a functionally closed, automated hollow fiber bioreactor system designed to reproducibly grow cells in either GMP or research laboratory environments. The chapter includes protocols for preparation of media, setup of the Quantum system, coating of the hollow fiber bioreactor, as well as loading, feeding, and harvesting of cells. We suggest a panel of quality controls for the starting material, the interim product, as well as the final product.
