French biotech centre to start making proteins, antibodies for trials in 2008
A new French biotech production facility, which will manufacture batches of recombinant proteins and monoclonal antibodies under GMP standards for clinical trials, is likely to become operational at the beginning of 2008.
A new French biotech production facility, which will manufacture batches of recombinant proteins and monoclonal antibodies under GMP standards for clinical trials, is likely to become operational at the beginning of 2008.
The production centre is being set up on the site of the Genopole "gene and biotech city" in Evry, south of Paris. It will collaborate with a centre belonging to the LFB fractioning and biotech laboratory in Toulouse to provide French biotech companies with a production facility for clinical trials.
Although there are 65 production centres for biotech products in Europe - most of them small - France has just three sites so far: a MabgEne-run site in AlEs in the south, which uses mammalian cells; Protein'Expert in Grenoble in the south-east, using yeast and bacteria; and Vivalis in Nantes in western France, which uses avian cells.
Genopole, which is semi-public, and the LFB, which is state-owned, began to study this project in detail in 2003, but in 2004 the LFB was mandated by the French government to set up a biotech production site in Toulouse.
Genopole continued to work on the idea of the Evry site, with the aim of 'working in harmony and not in competition' with the LFB. It was proposed to the Health Minister that "Evry would produce preclinical batches and clinical batches for phase I and II studies while the LFB would deal with production of larger batches for phase III," or even commercial batches, explained project head Alain Metayer.
The Evry project will have three bioreactors of 20, 30 and 1,750 litres respectively, which will be able to produce batches of 1-100g of purified protein on mammalian cells. A 1,300 m2 building managed by Genopole is being fitted out and equipped. The site will then be used by MabgEne which will pay rent. MabgEne, which already has a 300-litre bioreactor in AlEs, is also technical consultant for the design of the centre.
"The building is up, the work to achieve GMP standards will be done between September 2006 and spring 2007 and then we will begin qualification of the process.,' said Metayer. The centre, which should produce about 10 batches per year, will initially employ 12 to 15 people.
Metayer said the main clients would be biotech companies. However, public research organisations such as the French national institute for health and medical research (Inserm) are also likely to have "a need for GMP production in the coming years". The site will also be available for use by biotech companies from other European countries.