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Current challenges and opportunities in nonclinical safety testing of biologics

Moggs, Jonathan, Kronenberg, Sven, Baumann, Andreas, de Haan, Lolke, Hinton, Heather J, Theil, Frank-Peter, Wakefield, Ian and Singer, Thomas (2013) Current challenges and opportunities in nonclinical safety testing of biologics. Drug Discovery Today, 18 (23-24). pp. 1138-1143. ISSN 1878-5832


Nonclinical safety testing of new biotherapeutic entities represents its own challenges and opportunities in drug development. Hot topics in this field have been discussed recently at the 2nd Annual BioSafe European General Membership Meeting. In this feature article, discussions on the challenges surrounding the use of PEGylated therapeutic proteins, selection of cynomolgus monkey as preclinical species, unexpected pharmacokinetics of biologics and the safety implications thereof are summarized. In addition, new developments in immunosafety testing of biologics, the use of transgenic mouse models and PK and safety implications of multispecific targeting approaches are discussed. Overall, the increasing complexity of new biologic modalities and formats warrants tailor-made nonclinical development strategies and experimental testing. © 2013 Elsevier Ltd. All rights reserved.

Item Type: Article
Additional Information: This report summarises highlights of presentations given at a recent Basel BioSafe Workshop (including those based on OAK approved slides from Max Warncke and Jonathan Moggs within a preclinical toxicology species selection session chaired by Adam Hey) and does not contain any proprietary data.
Date Deposited: 13 Mar 2018 00:45
Last Modified: 25 Jan 2019 00:46