Non-clinical Safety Evaluation of Biotherapeutics – Challenges, Opportunities and new Insights

Guenter Blaich,Andreas Baumann,Sven Kronenberg,Lolke de Haan,Peter Ulrich,Wolfgang F. Richter,Jay Tibbitts,Simon Chivers,Edit Tarcsa, Robert Caldwell,Flavio Crameri

Regulatory Toxicology and Pharmacology（2016）

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摘要

New challenges and opportunities in nonclinical safety testing of biotherapeutics were presented and discussed at the 5th European BioSafe Annual General Membership meeting in November 2015 in Ludwigshafen. This article summarizes the presentations and discussions from both the main and the breakout sessions.

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关键词

Biotherapeutics,PEGylated biologics,Gene and cell therapy,Pharmacokinetics,Nonclinical safety,Antibody-drug conjugate,Immunogenicity,Cross-reactive species

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