Regulatory expertise
Vectalys can handle a whole project in house, committed on deadlines and managing regulatory constraints. All genetically cell and animal model projects have to be submitted to the French “commission de genie génétique (CGG)” to obtain the safety use recommandations. All the documents necessary to send to the CGG can be obtained on its web site: http://www.enseignementsup-recherche.gouv.fr/commis/genetique/default.htm
Vectalys provides all the information you need to fill up the request form of the CGG to obtain the right of use of viral vectors. The classification of the genetically modified cells by viral vectors depends of the insert type you have inserted in the lentiviral vector. All the case are listed in the table below:
“A “ means that the insert has no pathogenic effect. You can find a non exhaustive list of type A
and type B inserts in the site of the CGG.
All these instructions are strictly followed and checked by Vectalys. Before the release of viral vector or of the genetically modified cells to your laboratory, all the viral batches and cell supernatant are tested for the absence of specific viral matrix protein P24 by ELISA. Briefly, viral supernatants are used to transduce very permissive cells like HELA, 293T or HCT116 cells at MOI 10 and after 10 days ofcell culture, cell media is submitted to P24 ELISA:
