Manufacturing, characterization and control of cell-based medicinal products: Challenging paradigms toward commercial use

Regenerative Medicine

Volumn 10, Issue 1, 2015, Pages 65-78

  Salmikangas, Paula ^a   Menezes Ferreira, Margarida ^b   Reischl, Ilona ^c   Tsiftsoglou, Asterios ^d   Kyselovic, Jan ^e   Borg, John Joseph ^f   Ruiz, Sol ^a   Flory, Egbert ^g   Trouvin, Jean Hugues ^h   Celis, Patrick ⁱ   Ancans, Janis ^j   Timon, Marcos ^a   Pante, Guido ^k   Sladowski, Dariusz ^l   Lipnik Stangelj, Metoda ^m   Schneider, Christian K ^a  

^a Finnish Medicines Agency ^*  (Denmark)

^b INFARMED)   (Portugal)

^c AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY   (Austria)

^d ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^e Physics and Informatics   (Slovakia)

^f Awtoritàdwar Il Medicini Post Licensing Directorate   (Malta)

^g PAUL EHRLICH INSTITUT   (Germany)

^h UNIVERSITÉ PARIS DESCARTES   (France)

ⁱ EUROPEAN MEDICINES AGENCY   (United Kingdom)

^j UNIVERSITY OF LATVIA   (Latvia)

^k ITALIAN MEDICINES AGENCY   (Italy)

^l MEDICAL UNIVERSITY OF WARSAW   (Poland)

^m UNIVERSITY OF LJUBLJANA   (Slovenia)

more..

Author keywords

cell based; manufacturing; quality; regenerative; regulatory; therapy

Indexed keywords

ANALYTIC METHOD; BATCH CELL CULTURE; CELL FATE; CLINICAL EFFECTIVENESS; COMMERCIAL PHENOMENA; EMBRYONIC STEM CELL; ENGRAFTMENT; EUROPE; HUMAN; LICENSING; MANUFACTURING INDUSTRY; NONHUMAN; PLURIPOTENT STEM CELL; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; RISK FACTOR; STEM CELL; STEM CELL TRANSPLANTATION; VALIDATION PROCESS; CLINICAL TRIAL (TOPIC); CYTOLOGY; ECONOMICS; EUROPEAN UNION; LEGISLATION AND JURISPRUDENCE; SOCIAL CONTROL;

CLINICAL TRIALS AS TOPIC; COMMERCE; EUROPEAN UNION; HUMANS; SOCIAL CONTROL, FORMAL; STEM CELL TRANSPLANTATION; STEM CELLS;

EID: 84920722360     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.14.65     Document Type: Review

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