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Challenges with advanced therapy medicinal products and how to meet them.
Committee for Advanced Therapies (CAT); CAT Scientific Secretariat; Schneider CK, Salmikangas P, Jilma B, Flamion B, Todorova LR, Paphitou A, Haunerova I, Maimets T, Trouvin JH, Flory E, Tsiftsoglou A, Sarkadi B, Gudmundsson K, O'Donovan M, Migliaccio G, Ancāns J, Maciulaitis R, Robert JL, Samuel A, Ovelgönne JH, Hystad M, Fal AM, Lima BS, Moraru AS, Turcáni P, Zorec R, Ruiz S, Akerblom L, Narayanan G, Kent A, Bignami F, Dickson JG, Niederwieser D, Figuerola-Santos MA, Reischl IG, Beuneu C, Georgiev R, Vassiliou M, Pychova A, Clausen M, Methuen T, Lucas S, Schüssler-Lenz M, Kokkas V, Buzás Z, MacAleenan N, Galli MC, Linē A, Gulbinovic J, Berchem G, Fraczek M, Menezes-Ferreira M, Vilceanu N, Hrubisko M, Marinko P, Timón M, Cheng W, Crosbie GA, Meade N, di Paola ML, VandenDriessche T, Ljungman P, D'Apote L, Oliver-Diaz O, Büttel I, Celis P. Committee for Advanced Therapies (CAT), et al. Among authors: ancans j. Nat Rev Drug Discov. 2010 Mar;9(3):195-201. doi: 10.1038/nrd3052. Nat Rev Drug Discov. 2010. PMID: 20190786 Review.
Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.
Salmikangas P, Menezes-Ferreira M, Reischl I, Tsiftsoglou A, Kyselovic J, Borg JJ, Ruiz S, Flory E, Trouvin JH, Celis P, Ancans J, Timon M, Pante G, Sladowski D, Lipnik-Stangelj M, Schneider CK. Salmikangas P, et al. Among authors: ancans j. Regen Med. 2015;10(1):65-78. doi: 10.2217/rme.14.65. Regen Med. 2015. PMID: 25562353 Review.
Regulatory evaluation of Glybera in Europe - two committees, one mission.
Melchiorri D, Pani L, Gasparini P, Cossu G, Ancans J, Borg JJ, Drai C, Fiedor P, Flory E, Hudson I, Leufkens HG, Müller-Berghaus J, Narayanan G, Neugebauer B, Pokrotnieks J, Robert JL, Salmonson T, Schneider CK. Melchiorri D, et al. Among authors: ancans j. Nat Rev Drug Discov. 2013 Sep;12(9):719. doi: 10.1038/nrd3835-c1. Epub 2013 Aug 19. Nat Rev Drug Discov. 2013. PMID: 23954897 No abstract available.
Mesenchymal Stem Cells in Solid Organ Transplantation (MiSOT) Fourth Meeting: lessons learned from first clinical trials.
Franquesa M, Hoogduijn MJ, Reinders ME, Eggenhofer E, Engela AU, Mensah FK, Torras J, Pileggi A, van Kooten C, Mahon B, Detry O, Popp FC, Benseler V, Casiraghi F, Johnson C, Ancans J, Fillenberg B, delaRosa O, Aran JM, Roemeling-van Rhijn M, Pinxteren J, Perico N, Gotti E, Christ B, Reading J, Introna M, Deans R, Shagidulin M, Farré R, Rambaldi A, Sanchez-Fueyo A, Obermajer N, Pulin A, Dor FJ, Portero-Sanchez I, Baan CC, Rabelink TJ, Remuzzi G, Betjes MG, Dahlke MH, Grinyó JM; MiSOT Study Group. Franquesa M, et al. Among authors: ancans j. Transplantation. 2013 Aug 15;96(3):234-8. doi: 10.1097/TP.0b013e318298f9fa. Transplantation. 2013. PMID: 23759879 Free PMC article.
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