Cours de haut niveau sur les cellules souches Octobre 2006

Versailles Robert

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• Publié par: Ficir
• Nombre de lectures: 16
• Langue: English

Extrait

Creation of a Biomanufacturing
Center for recombinant proteins and
®monoclonal antibodies at Genopole


st ®Evry (France), September 21 2006 – The Genopole biopark and the MAbgène company have announced
the signature of a collaboration agreement for the creation and operation of a biomanufacturing center on
®the Genopole Evry bioccluster. By late 2007, the Center will produce recombinant proteins and
monoclonal antibodies to GMP* standards for use in preclinical testing and Phase I & II clinical trials. The
objective is to promote the development of the cluster's biotech companies, meet the needs of research
labs & institutes and offer an alternative production source to pharmaceutical companies. This marks an
®important step in Genopole's industrial development: by operating in synergy with the existing
®Généthon viral vector production unit, the new Center and its associated projects will position Genopole
as the benchmark for biomanufacturing in France.
* Good Manufacturing Practice

Meeting market needs and helping France make up ground
This project meets a real market requirement in terms of production capacity: The world biopharmaceutical
market (with a forecast turnover of 114 billion USD by 2010, 14% of the global pharma market) is generating
®significant demand and France is lagging behind in terms of clinical-grade biomanufacturing sites. The Genopole
Biomanufacturing Center in Evry should meet the needs of French and Europe-based biotech companies which
currently have difficulty producing their lead biomolecules. "Developing biomanufacturing in France is essential
for achieving the objectives of the Government's Cancer Plan: more than 30% of the anticancer drugs in the
® pipeline are biologics" stated Pierre Tambourin, Genopole's CEO.

Judicious technological choices and high-quality service provision
From 2007 on, the biomanufacturing unit produce batches of biological therapeutics (recombinant proteins and
monoclonal antibodies) with a fast turnaround time, at competitive prices and in full compliance with particularly
demanding GMP standards. The batches will be employed in preclinical animal testing and Phase II clinical trials
(and up to and including Phase III for orphan drug trials). "The biomolecules will be produced by genetically-
modified animal cells in culture, which should enable us to produce most types of complex proteins" adds Patrick
Henno, President of the MAbgène executive board.
2The 1,300 m unit will be equipped with bioreactors 300 and 1700 liters and will produce 8 batches per year, with
quantities ranging from 1 to 100 grams of purified protein. The center (operated by MAbgène) will employ a team
of 15 or so highly qualified staff (including a pharmacist, a production manager, a quality assurance specialist,
etc.) and will be audited by the French health administration in order to achieve GMP certification.

Ambitious plans
Given that the objective is to produce clients with a total solution, future projects will aim at completing the value
chain both upstream and downstream of production itself. These notably include the creation of a cell engineering
service company (development and optimization of the best expression systems for a given molecule) and a
®formulation & aseptic packaging unit (to enable "batch release" in the regulatory sense). Genopole and
MAbgène will together review opportunities to diversify their production technologies, which could result in the establishment of a second biomanufacturing center based on yeast-, bacteria- or plant cell-based techniques,
whilst also opening out into sectors other than healthcare (cosmetology, fine chemicals, the industrial exploitation
of agriresources, etc.).

The "New Perspectives in GMP Biomanufacturing" International Symposium
th ®On October 24 , Genopole (in association with EuroBiO 2006) is organizing an international symposium entitled
"New Perspectives in GMP Biomanufacturing". The prime objective is to bring together the world's leading sector
®specialists on the Genopole campus. This will be the first edition of what should become a biennial event and will
provide a snapshot of the main innovations in therapeutic-oriented biomanufacturing. See the previous press
threlease dated June 28 2006
For more information:
Symposium program and registration: www.genopole.fr/bioproduction/
www.eurobio2006.com


MAbgène is a French biotech company incorporated in 1997. Headquartered in Alès in southern France (where it
already runs a GMP pilot plant and manufacturing center), MAbgène has acknowledged expertise in GMP
production of recombinant proteins and monoclonal antibodies. The firm uses cell culture techniques on a
contract basis with private- and public-sector clients. After first implementing a GLP production tool which enabled
the company not only to meet the demands of the diagnostics & research reagent market but also to produce
several molecules at the same time, MAbgène established a second GMP-standard manufacturing tool in 2003
for batches ranging from 1 to 50 g of purified compound. The facility was ISO 9001 certified in 2001, audited by
the French health administration (AFSSAPS) in 2006 and has been awarded API status. In 2007, MAbgène
intends to become a registered pharmaceutical manufacturer. www.mabgene.com

®GENOPOLE is France's leading biopark dedicated to biotech & genetics research. It brings together private-
and academic labs, biotech companies and higher education facilities (the University of Evry Val d’Essonne) on a
90,000-square meter site. With 23 research labs on campus and a portfolio of over 60 biotech firms, therapeutic
® ®innovation is a key concern for Genopole stakeholders. Genopole 's objective is to promote research in
genomics, postgenomics and related sciences; reinforce technology transfer to the industrial sector; develop
high-level life science training & education programs and, lastly, to create and nurture biotech companies.
www.genopole.fr

® ®Genopole Press Contact : Symposium registration:
Bénédicte Robert Catherine Meignen
[phone] [phone]
[e-mail] [e-mail]