Alès, October 14, 2009. MAbgène (a subsidiary of the LFB Group), the contract manufacturing organization (CMO) based in Alès (southern France) and specialized in the production of antibodies and other glycoproteins in animal cell-based systems, announces a first-phase investment of € 5 million to expand its GMP facilities in preparation for the manufacture of phase III clinical and commercial batches of biomolecules.

 The first-phase construction is currently in progress and will be operational by Q2 2010. The new building will add 5,000 square feet of GMP facilities, warehouse, dedicated buffer and media preparation suites and support operations offices, resulting in a total space of approximately 8,500 square feet, including the existing pilot development unit.

The current GMP site complies with part II of the European GMP and is equipped with two independent lines of 300L bioreactor (stainless steel) and 1,000L bioreactor (disposable, operational by mid 2010). The introduction of the 1,000L disposable bioreactor technology will tremendously increase the bioproduction capacities in order to meet phase III clinical batches and future commercial supplies required for customers.

For MAbgène and LFB, this capacity expansion of the Alès site represents the achievement of the major objective to scale up our biomanufacturing activities”, said Patrick Henno, CEO of MAbgène. MAbgène is now the unique CMO in France with the capability to manufacture commercial batches of monoclonal antibodies and recombinant proteins using mammalian cell culture technology

About MAbgène

Founded in 1997, MAbgène is a fully integrated contract manufacturing organization based in Alès (southern France). MAbgène has acknowledged expertise in the GMP production of recombinant proteins and monoclonal antibodies using mammalian cell-based expression systems.

MAbgène provides process development and manufacturing services to  both private- and public-sector customers. MAbgène opened a GMP manufacturing facility in 2003 and is currently capable of producing materials to support Phase I to III clinical trials.

The company was ISO 9001-certified in 2001 and first audited by the French Health administration (AFSSAPS) in 2006 when it received certification for production of Active Pharmaceutical Ingredient (API) for certain monoclonal antibodies. In 2009, the MAbgène GMP site was certified as compliant with part II of the European GMP requirements.

MAbgène is a subsidiary of LFB, a French biopharmaceutical group.

For more information on MAbgene, please visit www.mabgene.com

About LFB
LFB is a pharmaceutical company, the first French company in the biotech field, the fifth largest pharmaceutical company in plasma-derived medicinal products, and the third laboratory supplying drugs to hospitals in France. LFB commercializes a wide range of 19 plasma-derived medicinal products addressing more than 80 pathologies in three therapeutic fields: Immunology, Homeostasis, and Intensive Care. Each year in France, 500,000 patients are treated with LFB's products for chronic pathologies or for emergency cases. In the biotechnology field, LFB develops monoclonal antibodies and a line of therapeutic proteins through transgenic technology with GTC Therapeutics. 

For more information on LFB, http://www.lfb.fr/

Press Contacts

 LFB                                                                     

Sandrine Charrières - Directeur de la Communication                                                  

Tel : +33 (0) 1 69 82 72 80 - charrieres@lfb.fr

Financial Dynamics

Florence de Montmarin

Tel : +33 (0) 1 47 03 68 10 - florence.demontmarin@fd.com

 MAbgène

Patrick HENNO

Tel : +33 (0) 4 66 56 40 80 - p.henno@mabgene.com