On Oct. 22, 2012, a consortium in France announced the establishment of Europe’s first ever industrial manufacturing facility dedicated to the large-scale production of novel, advanced cell-based therapy medicinal products. The plant, located in Les Ulis, near Paris, at the site of the French biopharmaceutical company LFB Biotechnologies, has the capacity to produce 3000 to 5000 therapeutic batches per year. The facility will be used for innovative R&D projects on autologous and allogeneic cell therapies that are progressing from early clinical research stage up to industrial production.
The facility project, known as C4C, is coordinated by CELLforCURE, a subsidiary of LFB Biotechnologies, and will involve two biotech companies—Celogos and CleanCells—as well as seven public organizations and university medical centers. Members of the consortium have invested EUR80 million (US$104 million) in the project alongside EUR30 million (US$39 million) public-sector financial aid provided by OSEO, France’s state innovation agency. The project seeks to provide an efficient pharmaceutical and industrial tool for improving patient access to cell therapies. Academic, public and private sector stakeholders will have access to the new facility for routine production of phase III clinical trial batches and commercial batches of new cell therapy products.
Five products are currently under development, with the first batches expected in late 2013, according to a press release.
- Bordeaux University Medical Center is collaborating with France’s National Blood Service (EFS) on the GRAPA program, which involves the ex vivo amplification of haematopoietic stem cells from placental blood for use in the treatment of bone marrow or lymph node malignancies (e.g., leukemia, lymphoma and myeloma), aplastic anemia, congenital immunodeficiencies and congenital enzyme deficiencies. The project is currently in Phase I/II development and aims to enable the transplant of ex-vivo-amplified placental blood stem cells into targeted patients.
- The CEL-02 cell therapeutic, developed by Celogos, is undergoing Phase II evaluation for the treatment of anal incontinence. Conditioned autologous muscle cells are injected directly into the damaged muscle to treat sphincter-related anal incontinence. Patient enrollment in the Phase II clinical trial has initiated at Rouen University Medical Center, with a Phase III clinical program planned for 2014.
- Autologous islet of Langerhans grafts for the treatment of post-pancreatectomy diabetes is in Phase I/II development. The procedure, developed by Professor François Pattou’s group at Lille University Medical Center/University of Lille 2, involves an intramuscular, autologous transplant of islets of Langerhans to provide long-term insulin independence in diabetic patients.
- A cell-based immunotherapeutic, developed at the Cell and Gene Therapy Unit at Nantes University Medical Center, is undergoing Phase III evaluation for the treatment of melanoma at the loco-regional invasion stage. Tumour-infiltrating lymphocytes (TILs) are administered in combination with low doses of interleukin-2 (IL-2) with the hope of preventing/slowing metastatic recurrence and improving overall survival in stage III melanoma after lymph node excision with a single invaded lymph node.
- The MESAMI (Mesenchymal and Myocardial Ischemia) program, conducted by Toulouse University Medical Center in partnership with the EFS to evaluate the potential use of mesencymal stem cells from bone marrow in combating left ventricular myocardial ischemia, is in Phase II development. Autologous bone marrow cells are cultured according to a well-defined procedure that makes it possible to expand the patient’s mesenchymal stem cells.
The industrial manufacturing facility will be validated through the production of these five innovative cell therapeutics and aims to meet the criteria set out by the European and North American health authorities and regulatory agencies. In addition to the C4C project’s own cell therapy products, the facility will offer custom manufacturing services.