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Clinical development of advanced therapy medicinal products in europe: evidence that regulators must be proactive

, , , , and . Mol Ther, 20 (3): 479-482 (2012)

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How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations, and . N Biotechnol, 25 (5): 280-286 (2009)After the TGN1412 incident. Principles for assessment of first-in-man trials with monoclonal antibodies by the Paul Ehrlich Institute, and . Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz, 50 (10): 1213-1220 (2007)Toward biosimilar monoclonal antibodies, and . Nat Biotechnol, 26 (9): 985-990 Review (2008)Development and regulation of biosimilars: current status and future challenges, , and . BioDrugs, 27 (3): 203-211 (2013)Clinical development of advanced therapy medicinal products in europe: evidence that regulators must be proactive, , , , and . Mol Ther, 20 (3): 479-482 (2012)Toward experimental assessment of receptor occupancy: TGN1412 revisited, , , , , , , and . J Allergy Clin Immunol, 122 (5): 890-892 (2008)Regulatorische Aspekte zu Biosimilars: Mythen und Fakten, and . Z Rheumatol, 74 (8): 695-700 (2015)Deciphering the EU clinical trials regulation, and . Nat Biotechnol, 34 (3): 231-233 (2016)Maintaining `standards' for biosimilar monoclonal antibodies, , , , , and . Nat Biotechnol, 39 (3): 276-280 (March 2021)Diagnostics and the coronavirus: don't let the standards slip, , , and . Nat Biotechnol, 38 (6): 673-674 (May 2020)