Biosimilars: what clinicians should know
Weise, Martina, Bielsky, Marie-Christine, De Smet, Karen, Ehmann, Falk, Ekman, Niklas, Giezen, Thijs J., Gravanis, Iordanis, Heim, Hans-Karl, Heinonen, Esa, Ho, Kowid, Moreau, Alexandre, Narayanan, Gopalan, Kruse, Nanna A., Reichmann, Gabriele, Thorpe, Robin, van Aerts, Leon, Vleminckx, Camille, Wadhwa, Meenu, Schneider, Christian K.
Published in Blood (20.12.2012)
Published in Blood (20.12.2012)
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Journal Article
Risk of tumorigenicity in mesenchymal stromal cell–based therapies—Bridging scientific observations and regulatory viewpoints
Barkholt, Lisbeth, Flory, Egbert, Jekerle, Veronika, Lucas-Samuel, Sophie, Ahnert, Peter, Bisset, Louise, Büscher, Dirk, Fibbe, Willem, Foussat, Arnaud, Kwa, Marcel, Lantz, Olivier, Mačiulaitis, Romaldas, Palomäki, Tiina, Schneider, Christian K, Sensebé, Luc, Tachdjian, Gérard, Tarte, Karin, Tosca, Lucie, Salmikangas, Paula
Published in Cytotherapy (Oxford, England) (01.07.2013)
Published in Cytotherapy (Oxford, England) (01.07.2013)
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Journal Article
What’s in a word? Defining “gene therapy medicines”
von Fritschen, Maren, Janosz, Ewa, Blume, Constanze, Jägle, Ulrike, Keating, Karen, Schneider, Christian K.
Published in Molecular therapy. Methods & clinical development (12.12.2024)
Published in Molecular therapy. Methods & clinical development (12.12.2024)
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Journal Article
Regulatory evaluation of Glybera in Europe — two committees, one mission
Melchiorri, Daniela, Pani, Luca, Gasparini, Paolo, Cossu, Giulio, Ancans, Janis, Borg, John Joseph, Drai, Catherine, Fiedor, Piotr, Flory, Egbert, Hudson, Ian, Leufkens, Hubert G., Müller-Berghaus, Jan, Narayanan, Gopalan, Neugebauer, Brigitte, Pokrotnieks, Juris, Robert, Jean-Louis, Salmonson, Tomas, Schneider, Christian K.
Published in Nature reviews. Drug discovery (01.09.2013)
Published in Nature reviews. Drug discovery (01.09.2013)
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Journal Article
Biosimilars: the science of extrapolation
Weise, Martina, Kurki, Pekka, Wolff-Holz, Elena, Bielsky, Marie-Christine, Schneider, Christian K.
Published in Blood (20.11.2014)
Published in Blood (20.11.2014)
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Journal Article
Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use
Salmikangas, Paula, Menezes-Ferreira, Margarida, Reischl, Ilona, Tsiftsoglou, Asterios, Kyselovic, Jan, Borg, John Joseph, Ruiz, Sol, Flory, Egbert, Trouvin, Jean-Hugues, Celis, Patrick, Ancans, Janis, Timon, Marcos, Pante, Guido, Sladowski, Dariusz, Lipnik-Stangelj, Metoda, Schneider, Christian K
Published in Regenerative medicine (01.01.2015)
Published in Regenerative medicine (01.01.2015)
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Journal Article
Reconstitution of Paired T Cell Receptor α- and β-Chains from Microdissected Single Cells of Human Inflammatory Tissues
Seitz, Sabine, Schneider, Christian K., Malotka, Joachim, Nong, Xiao, Engel, Andrew G., Wekerle, Hartmut, Hohlfeld, Reinhard, Dornmair, Klaus
Published in Proceedings of the National Academy of Sciences - PNAS (08.08.2006)
Published in Proceedings of the National Academy of Sciences - PNAS (08.08.2006)
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Journal Article
Development of the First World Health Organization Lentiviral Vector Standard: Toward the Production Control and Standardization of Lentivirus-Based Gene Therapy Products
Zhao, Yuan, Stepto, Hannah, Schneider, Christian K
Published in Human gene therapy. Part B. Methods (01.08.2017)
Published in Human gene therapy. Part B. Methods (01.08.2017)
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Journal Article
Toward experimental assessment of receptor occupancy: TGN1412 revisited
Waibler, Zoe, PhD, Sender, Linda Y, Kamp, Christel, PhD, Müller-Berghaus, Jan, MD, Liedert, Bernd, PhD, Schneider, Christian K., MD, Löwer, Johannes, MD, PhD, Kalinke, Ulrich, PhD
Published in Journal of allergy and clinical immunology (01.11.2008)
Published in Journal of allergy and clinical immunology (01.11.2008)
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Journal Article
Diagnostics and the coronavirus: don’t let the standards slip
Page, Mark, Almond, Neil, Rose, Nicola J., Schneider, Christian K.
Published in Nature biotechnology (01.06.2020)
Published in Nature biotechnology (01.06.2020)
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Journal Article
Maintaining ‘standards’ for biosimilar monoclonal antibodies
Prior, Sandra, Metcalfe, Clive, Hufton, Simon E., Wadhwa, Meenu, Schneider, Christian K., Burns, Chris
Published in Nature biotechnology (01.03.2021)
Published in Nature biotechnology (01.03.2021)
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Journal Article
Cell therapy products: focus on issues with manufacturing and quality control of chimeric antigen receptor T‐cell therapies
Eyles, Jim E, Vessillier, Sandrine, Jones, Anika, Stacey, Glyn, Schneider, Christian K, Price, Jack
Published in Journal of chemical technology and biotechnology (1986) (01.04.2019)
Published in Journal of chemical technology and biotechnology (1986) (01.04.2019)
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Journal Article
The risks of risk aversion in drug regulation
Eichler, Hans-Georg, Bloechl-Daum, Brigitte, Brasseur, Daniel, Breckenridge, Alasdair, Leufkens, Hubert, Raine, June, Salmonson, Tomas, Schneider, Christian K., Rasi, Guido
Published in Nature reviews. Drug discovery (01.12.2013)
Published in Nature reviews. Drug discovery (01.12.2013)
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Journal Article
Biosimilars—why terminology matters
Weise, Martina, Bielsky, Marie-Christine, De Smet, Karen, Ehmann, Falk, Ekman, Niklas, Narayanan, Gopalan, Heim, Hans-Karl, Heinonen, Esa, Ho, Kowid, Thorpe, Robin, Vleminckx, Camille, Wadhwa, Meenu, Schneider, Christian K
Published in Nature biotechnology (01.08.2011)
Published in Nature biotechnology (01.08.2011)
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Journal Article