PARIS - U.S.-based Amgen Inc. is helping to finance the establishment of a cell therapy laboratory at a cancer clinic in Marseilles. The operation forms part of Amgen's strategy of helping university hospitals and cancer clinics in Europe to establish laboratories complying with the FDA's Good Manufacturing Practices standards so they can collaborate in the development of the biotechnology firm's products.
As Christian Cailliot, head of cell and gene therapy at Amgen France, told BioWorld International, one of the objectives of the French subsidiary is to “bring about a shift in product development from the U.S. to France.“
The new laboratory is being installed at the Institut Paoli-Calmettes and is due to be operational by the end of this year. It will cost FFr9 million to set up and Amgen is contributing FFr1.5 million. Most of the remainder is being provided by the local regional council (FFr4.5 million) and the departmental anticancer committee (FFr2 million).
The Institut Paoli-Calmettes will not be bound by an exclusive relationship with Amgen, since it will test and evaluate other companies' products and processes, just as Amgen has similar collaborative relationships with other laboratories.
The clinic already has facilities for manipulating blood or bone marrow cells extracted from patients, but the new lab will enable it to operate on a larger scale and handle a greater variety of operations. In 1997 it handled 220 transplants of cell strains, making it one of the largest centers for that kind of operation in Europe.
The laboratory will be designed to comply with stricter safety requirements than the good practice regulations laid down by the French Transplant Establishment (Etablissement Français des Greffes). It will employ 18 people to start with and will work in close cooperation with the clinic's gene therapy laboratory. - James Etheridge