title: Clinical-Grade Manufacturing of Therapeutic Human Mesenchymal Stem/Stromal Cells in Microcarrier-Based Culture Systems.
abstract: The therapeutic potential of mesenchymal stem/stromal cells (MSC) has triggered the need for high cell doses in a vast number of clinical applications. This demand requires the development of good manufacturing practices (GMP)-compliant ex vivo expansion protocols that should be effective to deliver a robust and reproducible supply of clinical-grade cells in a safe and cost-effective manner. Controlled stirred-tank bioreactor systems under xenogeneic (xeno)-free culture conditions offer ideal settings to develop and optimize cell manufacturing to meet the standards and needs of human MSC for cellular therapies. Herein we describe two microcarrier-based stirred culture systems using spinner flasks and controlled stirred-tank bioreactors under xeno-free conditions for the efficient ex vivo expansion of human bone marrow and adipose tissue-derived MSC.
authors.affiliation: Department of Bioengineering and iBB - Institute for Bioengineering and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, Lisboa, 1049-001, Portugal.
authors.forename: Ana
authors.initials: A
authors.lastname: Fernandes-Platzgummer
authors.affiliation: Department of Bioengineering and iBB - Institute for Bioengineering and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, Lisboa, 1049-001, Portugal.
authors.forename: Joana G
authors.initials: JG
authors.lastname: Carmelo
authors.affiliation: Department of Bioengineering and iBB - Institute for Bioengineering and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, Lisboa, 1049-001, Portugal. claudia_lobato@tecnico.ulisboa.pt.
authors.forename: Cláudia Lobato
authors.initials: CL
authors.lastname: da Silva
authors.affiliation: Department of Bioengineering and iBB - Institute for Bioengineering and Biosciences, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, Lisboa, 1049-001, Portugal.
authors.forename: Joaquim M S
authors.initials: JM
authors.lastname: Cabral
mesh_terms: D019149:Bioreactors; D018929:Cell Culture Techniques / Q000295:instrumentation* / Q000379:methods; D002454:Cell Differentiation; D049109:Cell Proliferation; D019983:Guideline Adherence; D006801:Humans; D016130:Immunophenotyping; D008420:Manufactured Materials / Q000592:standards*; D059630:Mesenchymal Stem Cells / Q000166:cytology*
keywords: Ex vivo expansion; Mesenchymal stem/stromal cells; Microcarriers; Scale-up; Spinner flask; Stirred-tank bioreactor; Xenogeneic-free