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

Regul Toxicol Pharmacol. 2016 Oct:80S:S1-S14. doi: 10.1016/j.yrtph.2016.08.012. Epub 2016 Aug 27.

Abstract

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. The following topics were covered in six main sessions: The following questions were discussed across 4 breakout sessions (i-iv) and a case-study based general discussion (v).

Keywords: Antibody-drug conjugate; Biotherapeutics; Cross-reactive species; Gene and cell therapy; Immunogenicity; Nonclinical safety; PEGylated biologics; Pharmacokinetics.

Publication types

  • Congress

MeSH terms

  • Animal Testing Alternatives / methods
  • Animals
  • Animals, Genetically Modified
  • Antibodies / adverse effects*
  • Antibodies / chemistry
  • Antibodies / immunology
  • Biological Products / adverse effects*
  • Biological Products / chemistry
  • Biological Products / immunology
  • Biological Products / pharmacokinetics
  • Cell- and Tissue-Based Therapy / adverse effects*
  • Cell- and Tissue-Based Therapy / methods
  • Drug Compounding
  • Genetic Therapy / adverse effects*
  • Genetic Therapy / methods
  • Humans
  • Models, Animal
  • Models, Theoretical
  • Patient Safety
  • Polyethylene Glycols / adverse effects
  • Risk Assessment
  • Toxicity Tests / methods*

Substances

  • Antibodies
  • Biological Products
  • Polyethylene Glycols