title: Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.
abstract: During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.
authors.affiliation: • Finnish Medicines Agency, Helsinki, Finland.
authors.forename: Paula
authors.initials: P
authors.lastname: Salmikangas
authors.forename: Margarida
authors.initials: M
authors.lastname: Menezes-Ferreira
authors.forename: Ilona
authors.initials: I
authors.lastname: Reischl
authors.forename: Asterios
authors.initials: A
authors.lastname: Tsiftsoglou
authors.forename: Jan
authors.initials: J
authors.lastname: Kyselovic
authors.forename: John Joseph
authors.initials: JJ
authors.lastname: Borg
authors.forename: Sol
authors.initials: S
authors.lastname: Ruiz
authors.forename: Egbert
authors.initials: E
authors.lastname: Flory
authors.forename: Jean-Hugues
authors.initials: JH
authors.lastname: Trouvin
authors.forename: Patrick
authors.initials: P
authors.lastname: Celis
authors.forename: Janis
authors.initials: J
authors.lastname: Ancans
authors.forename: Marcos
authors.initials: M
authors.lastname: Timon
authors.forename: Guido
authors.initials: G
authors.lastname: Pante
authors.forename: Dariusz
authors.initials: D
authors.lastname: Sladowski
authors.forename: Metoda
authors.initials: M
authors.lastname: Lipnik-Stangelj
authors.forename: Christian K
authors.initials: CK
authors.lastname: Schneider
mesh_terms: D002986:Clinical Trials as Topic; D003132:Commerce; D005062:European Union; D006801:Humans; D012926:Social Control, Formal; D033581:Stem Cell Transplantation / Q000191:economics* / Q000331:legislation & jurisprudence*; D013234:Stem Cells / Q000166:cytology*
keywords: cell-based; manufacturing; quality; regenerative; regulatory; therapy