Congrès France
Bioproduction
7ème édition
05 & 06 avril 2023
Rassembler et fédérer tous les acteurs au service de la filière
LFB
Partenaire Gold
MANUFACTURING OF MONOCLONAL ANTIBODIES AND RECOMBINANT PROTEINS
LFB BIOMANUFACTURING is a company of the LFB group and a medium-sized CDMO offering bioproduction services. LFB BIOMANUFACTURING operates a dedicated and fully owned bioproduction facility in Alès (south of France).
ONE–STOP–SHOP SERVICES
Over 25 years of experience have granted LFB BIOMANUFACTURING with the ability to address complex projects, with a successful track record in scale-up and GMP production of biopharmaceuticals at preclinical and clinical stages.
From cell line development to GMP manufacturing of biological medicinal products, we have gained a wide experience, particularly in the field of monoclonal antibodies and recombinant proteins, expressed in mammalian cells.
We provide the following services to our customers:
- – Cell line development and cell banking
- – Process development and scale-up
- – Manufacturing of clinical and commercial batches
- – Analytical development and testing
CUTTING–EDGE EQUIPMENT AND FLEXIBILITY IN A HIGH–LEVEL REGULATORY ENVIRONMENT
On its industrial facility in Alès (France), LFB BIOMANUFACTURING uses only robust, qualified equipment from renowned suppliers that meet high safety and quality standards for GMP production. High flexibility of the facility is achieved with single-use bioreactors and appropriate purification/filtration systems. The current bioreactor volumes available are 250L and 1,000L for production of clinical and commercial batches. Multiple 2000L bioreactors are being installed.
LFB BIOMANUFACTURING is regularly audited by customers as well as by French and foreign Health authorities. The cGMP certificate was renewed in October 2022 by the French ANSM Agency. Since 2020, we are approved by FDA and has been successfully reinspected in October 2022.
ESCAPE30 OUR NEW DEVELOPMENT STRATEGY
In November 2022 the management team of LFB BIOMANUFACTURING met to define the strategic path of the company, referred to as ESCAPE30, and its associated long-term priorities.
LFB BIOMANUFACTURING targets Excellence in Services as CDMO for monoclonal Antibodies and therapeutic Proteins in Europe by 2030 – this will contribute to the national sovereignty in the field.
LFB Biomanufacturing will harness its scientific heritage to help meet patients’ needs globally by providing top decile CDMO services of antibody and therapeutic protein-based therapies.
DEVELOPMENT SERVICES
LFB BIOMANUFACTURING offers development services, from pre-clinical to clinical stages : cell line development and banking, process development and scale-up.
LFB’s proprietary platform EMABling® allows LFB BIOMANUFACTURING to propose specific developments for high-ADCC monoclonal antibodies.
PROCESS DEVELOPMENT AND SCALE UP:
- – UPSTREAM AND DOWNSTREAM PROCESS DEVELOPMENT
Process development and scale-up are essential to obtain a cost-effective commercial product. LFB BIOMANUFACTURING’s services cover adaptation of cell line to serum/protein-free media and / or media optimization for yield improvement.
Upstream (USP) and downstream (DSP) process development are executed in state-of-the-art facilities. LFB BIOMANUFACTURING’s USP technological options include the ambr®15 and ambr®250 advanced microscale bioreactor system for media/feed optimization and single use bioreactors such as wave or disposable stirred tank systems for seed train / scale-up definition.
- – A PROVEN TRACK RECORD IN CHALLENGING PROCESSES AND SCALE-UP
LFB’s in-house scientists and network of experts will facilitate the development of optimum cell culture conditions for each cell line. Our engineering staffs possess a strong experience and a technical knowledge for the selection of optimal chromatography and filtration/purification processes and viral clearance methods.
LFB BIOMANUFACTURING has a proven track records in tackling several challenging processes and scale-ups, resulting in successful production of many antibodies and recombinant proteins :
- – Cell culture process development
- – Media optimization, yield improvement
- – Media preparation
- – Downstream Process development
- – Manufacturing of non-GMP batches at 50L in pilot area and up to 1000L in one of the 3 multi-purpose workshops. Additional capacities up to 6x 2000L are being installed.
La France s’est fixé pour priorité d’assurer sa souveraineté sanitaire. Pour y arriver, elle doit regagner son leadership européen et accélérer la transition de son industrie (bio)pharmaceutique. Seule une action collective, permettra de relever ces défis.
Polepharma structure la filière industrielle (bio)pharmaceutique française et accompagne sa transformation depuis 20 ans.
POLEPHARMA
21 rue de Loigny la Bataille
28000 Chartres
Tél. : +33 (0)2 37 20 99 90
Mail : contact@polepharma.com
Le pôle Medicen fédère un réseau d’excellence en innovation sur le territoire francilien et au niveau national. En rassemblant acteurs privés et publics autour des enjeux d’innovation pour développer les solutions thérapeutiques de demain, Medicen est le tiers de confiance de la filière, au service du développement et de l’aboutissement des projets.
MEDICEN
130 Rue de Lourmel
75015 Paris
Tél. : +33 (0)1 79 68 10 87
Mail : medicenparisregion@medicen.org