Development of the First World Health Organization Lentiviral Vector Standard: Toward the Production Control and Standardization of Lentivirus-Based Gene Therapy Products

le Zhao, Yuan, Stepto, Hannah, Schneider, Christian K
Foilsithe in Hum Gene Ther Methods (2017)

First-in-human clinical trials with vaccines—what regulators want

le Goetz, Karen B, Pfleiderer, Michael, Schneider, Christian K
Foilsithe in Nat Biotechnol (2010)

The Evolution of Nonclinical Regulatory Science: Advanced Therapy Medicinal Products as a Paradigm

le Vestergaard, Henrik Tang, Apote, Lucia D', Schneider, Christian K, Herberts, Carla
Foilsithe 2013

Clinical Development of Advanced Therapy Medicinal Products in Europe: Evidence That Regulators Must Be Proactive

le Maciulaitis, Romaldas, D'Apote, Lucia, Buchanan, Andrew, Pioppo, Laura, Schneider, Christian K
Foilsithe 2012

Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union

le van Aerts, Leon AGJM, De Smet, Karen, Reichmann, Gabriele, van der Laan, Jan Willem, Schneider, Christian K
Foilsithe in MAbs (2014)

Reconstitution of paired T cell receptor α- and β-chains from microdissected single cells of human inflammatory tissues

le Seitz, Sabine, Schneider, Christian K., Malotka, Joachim, Nong, Xiao, Engel, Andrew G., Wekerle, Hartmut, Hohlfeld, Reinhard, Dornmair, Klaus
Foilsithe 2006

Implementing quality by design for biotech products: Are regulators on track?

le Luciani, Francesca, Galluzzo, Sara, Gaggioli, Andrea, Kruse, Nanna Aaby, Venneugues, Pascal, Schneider, Christian K, Pini, Carlo, Melchiorri, Daniela
Foilsithe in MAbs (2015)