2014/01/06 by Aline Baldo, Eric den Akker, Hans Bergmans +2 · 2 citations
Biochemistry, Genetics and Molecular Biology · #Virus-based gene therapy research #Viral Infectious Diseases and Gene Expression in Insects #CRISPR and Genetic Engineering
paper · pdf · doi:10.2174/15665232113136660005
openalex publication_date 2014/01/06 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/31
This introductory paper gathers general considerations on the biosafety of virus-derived vectors that are used in human gene therapy and/or vaccination. The importance to assess the potential risks for human health and the environment related to the use of genetically modified organisms (GMO) in this case genetically modified viral vectors is highlighted by several examples. This environmental risk assessment is one of the requirements within the European regulatory framework covering the conduct of clinical trials using GMO. Risk assessment methodologies for the environmental risk assessment of genetically modified virus-derived vectors have been developed.