The Cell and Gene Therapy Unit (UTCG) has been designed to meet requirements ranging from conception to administration of cellular products. Under the direction of Nantes University Hospital, UTCG has more than 20 years of experience in the production of clinical batches which are delivered in accordance with GMP, guaranteeing their quality, safety and traceability. Its activity is centred on phase I/II studies, corresponding to the concept of an exploratory platform in the field of advanced therapies.
Field of activity:
Cell therapy and ex-vivo gene therapy
Know-how, expertise available:
She has expertise applied to several cell types, which is unique in France: lymphocytes, dendritic cells, keratinocytes, fibroblasts, chondrocytes, myoblasts, embryonic cells, iPS and fetal cells).
His technical know-how is also varied: Cell differentiation and maturation, cell purification, simple or complex cell selection, cell expansion, cell loading, cryopreservation, custom development.
Ex vivo gene therapy activity, in particular production of CARs vectors.
An integrated offer from development to clinical production:
– Adaptation to production according to the project’s needs,
– Production of clinical batches (cell therapy and ex vivo gene therapy) for industrial or institutional Phase I / II clinical trials,
– Provision of regulatory advice and assistance.
– ATMP pharmaceutical management
– Training: interns in medicine or pharmacy.
Quality labels and accreditations:
– ISO 9001 certification since 2003
– French Health (ANSM) authorizations for ATMP hospital exemption activities and allogenic haematopoietic stem cells
– GMO approvals from the French Ministry of Research for the use of GMOs of class 2, L2 containment in connection with specific projects
– Regional Health Agency authorization for the pharmaceutical management of ATMP
Automated cell engineering
9 quai Moncousu
44093 Nantes Cedex 01
Responsable scientifique : Pr. Brigitte Dréno
Tél : +33 (0)2 40 08 47 09
Email : firstname.lastname@example.org