Structure Fédérative de Recherche Bonamy

Cell and Gene Therapy Unit (UTCG)

Discover the « Cell and Gene Therapy Unit » of the Nantes University Hospital, a hospital unit dedicated to the bioproduction of Advanced Therapy Drugs (ATD) for nearly 30 years.

Our expertise dedicated to clinical research

Within the framework of academic or industrial partnerships, our mission is to adapt and to transfer innovative production processes developed by research units or start-ups, to a level of production compatible with clinical use. This activity is governed by an ISO 9001 quality management system that guarantees the quality and the safety of the products manufactured as well as the complete traceability of operations. The UTCG ensures the clinical-grade production of ATDs and the management of their quality control.

The UTCG objective is to provide innovative products for clinical care in fields such as oncology, autoimmunity or regenerative medicine.

Which cells? 

UTCG has expertise in cell engineering processes (selection, amplification, gene transformation) applied to a variety of cell types in many clinical applications:

  • T cells, including tumor-infiltrating T cells (TILs) or modified T cells such as CAR T-cells
  • Mesenchymal cells
  • Monocytes
  • Hematopoientic stem cells
  • Skin cells

Our spaces

The UTCG includes: 

  • 2 controlled atmosphere production areas of 330 m² including 6 cell culture rooms and dedicated to the production of cell therapy and ex vivo gene therapy products.
  • 1 quality control laboratory
  • 1 research and development laboratory
We work in compliance with Good Manufacturing Practices (GMP)

Our offer

Clinical Research

Production and control of Investigational Advanced Therapy Medicinal Products (experimental ATD) or Prepared Ad Hoc Medicinal Products (ADP-PP) in the context of clinical trials authorized by regulatory authorities. This activity is carried out in compliance with the applicable Good Manufacturing Practices (GMP).

Process development in academic or industrial partnership

Assistance in the development of production processes and associated quality controls, taking into account the regulatory constraints that can be applied for a clinical trial authorization, with support for the preparation of regulatory dossiers.

Care

Immuno-selection activity of CD34+ hematopoietic progenitors for the treatment of allografted patients to enable reconstitution of hematopoiesis while limiting the risk of host-on-host reaction (GvHD) occurrence.

Related activities

Production of research-grade or clinical-grade cell banks
Production of cellular reagents such as B-EBV (EBV-LCL) lines that can be used for the selection of anti-EBV T cells or NK cells
Transfer of HLA-Typed B-EBV Lines for NK Cell Selection
Performing EBV infectivity tests on permissive cells


Collaborations

 

Mis à jour le 19 August 2024.
https://sfrsante.univ-nantes.fr/en/technological-facilities/cell-and-gene-therapy-unit-utcg-1