An innovative GMP bioproduction site for the manufacture of your recombinant biomedicinal products
Our production site, located in the south of France in Alès (30), is GMP (BPF (French Good Manufacturing Practice) certified, to meet the highest quality and safety standards for the production of your cell lines and recombinant antibodies.
An experienced and agile CDMO team that understands your pharmaceutical challenges
At LFB BIOMANUFACTURING, our team is highly experienced and flexible, made up of specialists in the manufacturing of recombinant medicinal products, which means we offer top-notch services, whatever your needs. We bring together project teams tailor-made to meet your objectives for developing cell lines, recombinant antibodies or industrial processes.
“A multidisciplinary team dedicated to your project.”
LFB BIOMANUFACTURING offers CDMO services thanks to tailor-made structures adapted specifically to your projects. The services are managed by a dedicated project manager, supported by a multidisciplinary team made up of several specialists. The project is conducted in close collaboration with you, to ensure that all milestones are met, production costs are controlled and planned deadlines are met.
Our goal as pharmaceutical CDMO experts: to ensure that your biomedicinal product development projects at the pre-clinical and clinical stages are carried out in strict accordance with your specifications.
As part of the LFB Group, LFB BIOMANUFACTURING benefits from all the necessary legal expertise to ensure that the contractual part of your pharmaceutical and biotechnology projects meets the highest standards.
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An industrial site with cutting-edge technologies and flexibility in an environment that meets the highest regulatory standards
At our LFB BIOMANUFACTURING industrial production site in Alès (France), we only use robust and qualified technologies, from recognised suppliers such as Sartorius, which meet the highest quality and safety standards in a GMP framework.
The high flexibility offered by our site relies in particular on the use of single-use bioreactors and automated systems for purification and filtration, specially designed for multi-product use. The bioreactor volumes currently available for the production of clinical and commercial batches of medicinal products are 250 litres and 1000 litres. We are in the process of installing 2000 litre bioreactors as well. In addition, LFB BIOMANUFACTURING’s multiple upstream and downstream USP DSP capabilities enable simultaneous production for both the LFB Group and all of our customers.
LFB BIOMANUFACTURING can also help you benefit from the French Research Tax Credit (CIR).
Our strong expertise in biopharmaceuticals
With more than 25 years of experience, LFB BIOMANUFACTURING is able to take on complex projects, thanks in particular to our long history of successful production of recombinant medicinal products at the pre-clinical and clinical stages, as well as industrial scale-ups.
As part of the LFB Group, a major player in the field of biological medicinal products, we benefit from its wide range of industrial and pharmaceutical expertise, including key functions for the implementation of analytical methods for the characterisation of proteins, protein formulation, biological security as well as regulatory aspects.
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.