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New challenges and opportunities in nonclinical safety testing of biologics

Authors
Journal
Regulatory Toxicology and Pharmacology
0273-2300
Publisher
Elsevier
Volume
69
Issue
2
Identifiers
DOI: 10.1016/j.yrtph.2014.04.005
Keywords
  • Biologics
  • Pharmacokinetics
  • Non-Clinical Safety
  • Minipigs
  • Pegylated Proteins
  • Distribution
  • Bispecifics
Disciplines
  • Biology
  • Pharmacology

Abstract

Abstract New challenges and opportunities in nonclinical safety testing of biologics were discussed at the 3rd European BioSafe Annual General Membership meeting in November 2013 in Berlin: (i) Approaches to refine use of non-human primates in non-clinical safety testing of biologics and current experience on the use of minipigs as alternative non-rodent species. (ii) Tissue distribution studies as a useful tool to support pharmacokinetic/pharmacodynamic (PKPD) assessment of biologics, in that they provide valuable mechanistic insights at drug levels at the site of action. (iii) Mechanisms of nonspecific toxicity of antibody drug conjugates (ADC) and ways to increase the safety margins. (iv) Although biologics toxicity typically manifests as exaggerated pharmacology there are some reported case studies on unexpected toxicity. (v) Specifics of non-clinical development approaches of noncanonical monoclonal antibodies (mAbs), like bispecifics and nanobodies.

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