FDA approved site
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.
International certifications (BPF/cGMP)
LFB BIOMANUFACTURING is regularly audited by numerous customers as well as by the supervisory health authorities and those of foreign countries (ANSM (French National Agency of Medicines and Health Products Safety) in France, for example). LFB BIOMANUFACTURING’s certificate of compliance with good manufacturing practices (BPF (French Good Manufacturing Practice)/GMP) was renewed in 2023 by the ANSM (French National Agency of Medicines and Health Products Safety).
LFB BIOMANUFACTURING has been approved by the US FDA (Food and Drug Administration) since 2020, and passed its last inspection successfully in 2022.