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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: trouvin jh. 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: trouvin jh. Regen Med. 2015;10(1):65-78. doi: 10.2217/rme.14.65. Regen Med. 2015. PMID: 25562353 Review.
[Regulatory framework of cell therapy products].
Moussaoui S, Lucas S, Zorzi P, Le Saulnier C, Trouvin JH. Moussaoui S, et al. Among authors: trouvin jh. Bull Cancer. 2003 Aug-Sep;90(8-9):779-88. Bull Cancer. 2003. PMID: 14609769 Free article. French.
Setting the stage for biosimilar monoclonal antibodies.
Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, Thirstrup S. Schneider CK, et al. Among authors: trouvin jh. Nat Biotechnol. 2012 Dec;30(12):1179-85. doi: 10.1038/nbt.2447. Nat Biotechnol. 2012. PMID: 23222783 No abstract available.
In support of the European Union biosimilar framework.
Schneider CK, Borg JJ, Ehmann F, Ekman N, Heinonen E, Ho K, Hoefnagel MH, van der Plas RM, Ruiz S, van der Stappen AJ, Thorpe R, Tiitso K, Tsiftsoglou AS, Vleminckx C, Waxenecker G, Welin M, Weise M, Trouvin JH; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP); Biologicals Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP). Schneider CK, et al. Among authors: trouvin jh. Nat Biotechnol. 2012 Aug;30(8):745-8; author reply 748-9. doi: 10.1038/nbt.2322. Nat Biotechnol. 2012. PMID: 22871707 No abstract available.
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