The industrial component of the French cell therapy sector was built with the backing of BPI France (the French public investment bank) under France’s “Investing in the Future” program.
The first products will be produced on the plant by the end of 2013. CELLforCURE is inaugurating the first-ever European facility for the large-scale manufacturing of advanced therapy medicinal products.
At the inauguration, a first international partnership agreement with the Canadian organization Héma-Québec will also be signed.
The new manufacturing facility is located in Les Ulis (Essonne), France and is operated under the coordination of CELLforCURE, a specialized subsidiary established in 2010 by the French biopharmaceutical group LFB.
The facility is a key component of the path for the future of the French cell therapy industry.
The new facility will allow autologous and allogeneic cell therapies R&D projects resulting from public research or by small and medium businesses, all the way through to industrial production.
With this pharmaceutical platform, cell therapies will be more accessible to patients and will position French cell therapy industry on the international scene.
Les Ulis plant will have an annual production capacity of 5000 therapeutic batches and will have the capacity to manufacture 8 different products simultaneously. The LFB group has invested 18 million euros in the facility.
Starting the production with Five Cell Therapies
Five innovative cell therapy medicinal products, that are currently being developed as part of the C4C project funded by the “Investing in the Future” program and BPI France, will be first manufactured in the CellForCure facility.
C4C is based on the expertise of CELLforCURE and its partners: biotechnology companies (Celogos and Clean Cells), the EFS (French National Blood Bank) through its regional branches in the Aquitaine–Limousin and Pyrénées-Méditerranée regions, Bordeaux University Medical Center, the Lille Regional University Medical Center/University of Lille 2, the Nantes University Medical Center, the Toulouse University Medical Center, and the Tissue and Cell Bank [Banque de Tissus et de Cellules-BTC] and Civil Hospices of Lyon [Hospices Civils de Lyon-HCL].
These products use various types of cells: cord-blood stem cells, lymphocytes, hematopoietic stem cells, immunologically competent cells, and progenitor or adult somatic cells.
In addition to the five cell therapy products of the C4C Project, the new industrial facility will be manufacturing products for other customers in the private and public sectors beginning in 2014.
Signing a First International Partnership Agreement
On the occasion of the inauguration, CELLforCURE will sign its first international partnership agreement, with the Canadian non-profit organization Héma-Québec; Jean de Serres, president and CEO of this organization, will be there for the signing. This agreement will provide CELLforCURE, with a North American production partner approved by the U.S. and Canadian authorities.
It will speed up access to the North American continent for both CELLforCURE’s products and those of its European customers. By the same token, CELLforCURE will be able to offer a European entry point to Héma-Québec customers wishing to expand their products’ markets into Europe.
Cell therapy: definitions and issues
Although Europe's first marketing authorization for a cell therapeutic was granted in October 2009, the cell therapy market is set to be worth an estimated 5 billion US dollars by 2015 and could double again to reach 10 billion US dollars in 2020.
Cell therapy involves the administration of human cells to prevent, treat or alleviate a disease. In some situations, the administered cells repair and/or rebuild damaged tissue. In others, modified cells are used to provide tissue with compounds that it previously lacked.
Cell therapy is at the heart of tomorrow's personalized medicine and is expected to provide new ways of preventing or treating a wide range of diseases - many of which currently lack effective therapeutic solutions (e.g. certain cancers, neurodegenerative diseases, neuromuscular diseases and degenerative diseases like myocardial infarction, heart failure and rheumatoid arthritis).
In fact, this type of therapy is a "cell transplant" in which cells taken from the patient him/herself ("autologous" grafts) or a donor are selected, modified or treated in vitro before being administered (usually by injection) to the patient.
Hence, this approach often requires the use of completely new production models that are far removed from “traditional” pharmaceutical or biotechnological manufacturing processes.