General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination.

Last updated on 20-11-2019 by Anonymous (not verified)

Public Access

Published

Peer reviewed scientific article

English

Abstract:

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 assessme…

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