EFS Atlantic Bio GMP is a pharmaceutical establishment dedicated to the manufacturing and control of biological products for phase I/II Gene and Cell Therapy clinical trials

We propose the production of GMP compliant ATMPs, essentially for phase I/II clinical trials promotors, to guaranty the security and quality of this products destined to be injected to patients.  The objective is to reach a proof of concept for these innovative products as soon as possible and in a cost in coherence with our mission of public service

Field of activity :

GMP-compliant ATMPs :

  • Cell therapy products
  • Gene therapy products
  • Tissue engineered products

GMP-compliant QC testing in cell and gene therapy including validation of methods according EP and ICHQ2R1

Know-how, expertise available:

Mesenchymal Stem cells, selection and amplification of cells (CD34+, specific T cells,…)
Human embryonic stem cells: culture and differentiation
Manufacturing and aseptic filling of clinical AAV batches (different serotypes)
Quality control: expertise in Flow Cytometry and molecular biology assay

Services provided:

  • MCB / WCB production, MVSS production, development batches, transfer batches and GMP clinical lots
  • Characterization of raw materials and starting materials, in process controls and drug product controls in gene and cell therapy

Including training and staff possibilities: technological transfer

Quality labels and accreditations: GMP certificate, GMO authorization (HCB), authorization for hESC (ABM), certification: ISO 9001, ISO 14004 and OHSAS 18001

Technologies offered:

Cell therapy: selection of different cells (CliniMacs and Prodigy Miltenyi), cell amplification (Cells stacks, culture bags, Petri dishes)
Gene therapy: cell amplification (Cells Stacks), IEX chromatography (Akta Ready, Pilot, purifier), cesium chloride gradient ultracentrifugation, TFF (KRII Spectrum), aseptic filling
Quality Control : flow cytometry, qPCR, western blots, purity (DO), restriction profiles, functional assays, IF, filter integrity, physico-chemicals tests

EFS Etablissement Francais du Sang

Contact Atlantic Bio GMP

Rue Aronnax
BP 50051
44801 SAINT HERBLAIN

Sophie DERENNE
Tél : +33 (0)2 40 44 28 80

Visit  Atlantic Bio GMP