Author/Editor		Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Lipnik-Štangelj, Metoda
Title		Manufacturing, characterization and control of cell-based medicinal products
Type		članek
Vol. and No.		Letnik 10, št. 1
Publication year		2015
Volume		str. 65-78
ISSN		1746-0751 - Regenerative medicine
Language		eng
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.
Keywords		supervision of medicinal products manufacturing quality nadzor zdravil proizvodnja kakovost