title: GMP-Compliant Expansion of Clinical-Grade Human Mesenchymal Stromal/Stem Cells Using a Closed Hollow Fiber Bioreactor.
abstract: 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.
authors.affiliation: Department of Hematology, Oncology and Immunology, University Hospital Giessen and Marburg, Philipps-University Marburg, Marburg, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Barckhausen
authors.affiliation: TerumoBCT, Lakewood, CO, USA.
authors.forename: Brent
authors.initials: B
authors.lastname: Rice
authors.affiliation: TerumoBCT, Zaventem, Belgium.
authors.forename: Stefano
authors.initials: S
authors.lastname: Baila
authors.affiliation: UMR5273-U1031 STROMALab, CNRS, INSERM, Université Paul Sabatier Toulouse, EFS, Toulouse, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Sensebé
authors.affiliation: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg - Hessen, Ulm, Germany.|Institut für Transfusionsmedizin, Universitätsklinikum Ulm, Helmholtzstraße 10, Ulm, 89081, Germany.
authors.forename: Hubert
authors.initials: H
authors.lastname: Schrezenmeier
authors.affiliation: Department of Hematology, Oncology and Immunology, University Hospital Giessen and Marburg, Philipps-University Marburg, Marburg, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Nold
authors.affiliation: Institute for Clinical Immunology and Transfusion Medicine, University Hospital Giessen and Marburg, Justus-Liebig-University Giessen, Giessen, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Hackstein
authors.affiliation: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm, DRK-Blutspendedienst Baden-Württemberg - Hessen, Ulm, Germany. markus.rojewski@uni-ulm.de.|Institut für Transfusionsmedizin, Universitätsklinikum Ulm, Helmholtzstraße 10, Ulm, 89081, Germany. markus.rojewski@uni-ulm.de.
authors.forename: Markus Thomas
authors.initials: MT
authors.lastname: Rojewski
mesh_terms: D019149:Bioreactors; D018929:Cell Culture Techniques / Q000295:instrumentation*; D002454:Cell Differentiation; D049109:Cell Proliferation; D002478:Cells, Cultured; D003470:Culture Media / Q000737:chemistry; D006801:Humans; D008420:Manufactured Materials / Q000592:standards*; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D011786:Quality Control; D011789:Quantum Theory
chemical_list: D003470:Culture Media
keywords: Bioreactor; Clinical application; Functionally closed; GMP; Glucose consumption; Hollow fiber; Lactate generation; MSC; Mesenchymal stem cells; Mesenchymal stromal cells; Platelet lysate