[Sanitary safety of GMOs used in therapeutics].
The recent progress in human therapeutics has been made possible thanks to molecular biology and its use in producing proteins having the same sequence and structure as that of human proteins. The use of GMOs allows production of proteins with high added value in therapeutics, which are of satisfactory quality. GMOs may also be directly administered to patients as gene therapy vectors. However, the use of GMOs in therapeutics must take into consideration some risks, particularly those of microbiological contamination, of neo-antigenicity as well as environmental risks with regard to the way of use of the GMO. Nevertheless, those risks are taken in due consideration in the development of those new medicinal products; solutions have been found to allow their use in therapeutics with a very positive benefit/risk ratio. Medicinal products from biotechnology have permitted considerable therapeutic progress without compromising health security.
Trouvin
Jean-Hugues
JH
Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), 143 Bd A. France, 93285 Saint-Denis.
D003257:Consumer Product Safety; D006801:Humans; D030781:Organisms, Genetically Modified; D011786:Quality Control; D013812:Therapeutics / Q000009:adverse effects / Q000379:methods*