Our facilities for the bioproduction of recombinant medicinal products by cell culture
At our LFB BIOMANUFACTURING site based in Alès (30), we implement robust cutting-edge technologies and cutting-edge industrial equipment for the manufacture of recombinant proteins and monoclonal antibodies to GMP standards issued by the ANSM (French National Agency of Medicines and Health Products Safety).
Dedicated production units
“State-of-the-art facilities to meet the specific needs of each customer.”
♦ Production Unit 1
Production of cell banks
Purification of LFB’s recombinant activated Factor VII
♦ Production Unit 2
Cell culture in 200 to 2000 L bioreactors
Purification of the protein of interest
♦ Production Unit 3
Purification of the animal-derived protein of interest
♦ Media and Buffers Preparation Unit
Preparation of media and buffers
Pharmaceutical BPF (French Good Manufacturing Practice)/GMP certification for clinical studies and commercial batches
Using cutting-edge technologies with single-use bioreactors, we manufacture the active substances for clinical and commercial batches of recombinant medicinal products in a BPF (French Good Manufacturing Practice)/GMP framework. Purification buffers and cell culture media are manufactured under GMP-compliant conditions, in dedicated production units, using single-use equipment.
"At LFB BIOMANUFACTURING, all our cell and antibody manufacturing and development units have GMP certification (BPF (French Good Manufacturing Practice) standards)."
LFB BIOMANUFACTURING also recently acquired a 3rd production unit dedicated specifically to the production of molecules requiring specific viral safety and which has been put to good use by many customers for the manufacture of anti-COVID therapies.
Our cGMP (BPF) CDMO services
♦ Master Cell Banks (MCB) and Working Cell Banks (WCB) to GMP standards
♦ API manufacturing to GMP standards for clinical and commercial batches from 250 L to 1000 L – additional capacities are under construction.
♦ Quality Control and Stability Studies
♦ CMC regulatory support
How are recombinant medicinal products manufactured by cell culture?
Our GMP certification issued by the ANSM (French National Agency of Medicines and Health Products Safety)
