French Biomanufacturing Center for Recombinant Proteins and Mabs to Be Operational in 2007
Genopole biopark and MAbgene inked a collaboration agreement for the creation and operation of a biomanufacturing center on the Genopole Evry biocluster. It is hoped that by late 2007 the center will produce recombinant proteins and Mabs to GMP standards.
According to the companies, France is lagging behind in terms of clinical-grade biomanufacturing sites. The Genopole Biomanufacturing Center should meet the needs of French and European biotech companies that currently have difficulty producing their lead molecules.
The biomanufacturing unit will use modified animal cells to produce batches of GMP-grade recombinant proteins and Mabs. The batches will be employed in preclinical animal testing, Phase II trials, and up to and including Phase III for orphan drug trials.
The 1,300-m2 unit will be equipped with 300- and 1,700-L bioreactors and will produce eight batches per year, ranging from 1 and 100 grams of purified protein.
A number of related projects are in Genopole’s pipeline—the creation of a cell engineering service company and a formulation and aseptic packaging unit. Genopole and MAbgene 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.