LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

Transcription

1 LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

2 MAbLaunch TM is a joint bioproduction platform combining LFB Biomanufacturing (LFB Group) and BioLaunch (Sanofi) capabilities in the field of contract and manufacturing services. The platform is supported by a collaboration agreement between Sanofi* and the LFB Group** to capitalize on the use of their respective industrial capacities and to provide the widest range of CMO services to customers in the most flexible manner. MAbLaunch TM has developed considerable expertise in process and manufacturing of monoclonal antibodies and recombinant proteins using mammalian cell technology. The MAbLaunch TM offer starts with cell line, going through process and scale up and continuing into manufacturing of clinical and commercial batches. *through its subsidiary Sanofi Chimie **through its subsidiary LFB Biotechnologies Pilot facilities: Process, pilot production and scale-up Bioengineering laboratory Mammalian cell line platforms ( CHO and YB2/0 - EMABling ) Quality Control laboratory Roller bottle systems Spinners 25L Wave system 40L stainless steel bioreactor 50L & 200L disposable bioreactors Chromatography systems Virus inactivation and nanofiltration Filtration, ultrafiltration Analytical systems GMP production facilities: USP: 6 independent bioproduction lines with the following bioreactor capacities: > 1x 300L (stainless steel bioreactor) > 1x 1,000L (disposable bioreactor) > 1x 2,000L (disposable bioreactor; available soon > 3x 10,000L (stainless steel bioreactors) Industrial chromatography systems Ultrafiltration/Diafiltration systems Viral inactivation/nanofiltration Fill and finish facilities: > Pre-filled syringes from 0.5mL to 20mL > Cartridges from 1.7mL to 3.2mL > Vials from 2mL to 150mL > Lyophilized vials from 2mL to 20mL > Dosing system: time/pressure or peristaltic pump Inspection: automated or semi-automated

3 Contract Biomanufac Service Discovery Pre-clinical Clinical Registration Commercialization Expression vector construction MAb chimerization and humanization Cell line Vector transfection and transient expression Stable cell line generation and clone selection EMABling technology (see details on the right page ) Cell banking Project management Quality assurance Regulatory support Process and scale-up Cell culture Process - Media optimization, yield improvement Downstream Process Viral clearance validation Manufacturing of non-gmp batches up to 200L Analytical stability studies - QC testing GMP master and working cell bank production Manufacturing of GMP batches at 300L and 1,000L scale Manufacturing of clinical and commercial batches Manufacturing of GMP batches at 10,000L scale Galenic form Fill and finish vials, pre-filled syringes, freeze-dried vials, cartridges Stability studies Clinical packing

4 turing Services offer Cell line MAbLaunch TM is able to offer bioproduction services using the client s own cell line, or through a specific cell line program, to express the client s recombinant protein, using proprietary or non-proprietary cell expression systems. The different steps may include molecular and cellular engineering to create a chimeric or humanized monoclonal antibody by vector construction, gene transfection and cell line in order to establish a stable cell line. NEW! EMABling technology EMABling is a technology developed by the LFB Group to produce highy active recombinant monoclonal antibodies using the YB2/0 cell line. These antibodies display an enhanced antibody-dependent cellular cytotoxicity (ADCC) activity due to an improved glycosylation profile. LFB s research in this area has been based on the study of structure-function relationships for monoclonal antibodies and critical impact of post-translational modifications to their functional activity (role of glycans). Combined with specifically optimized expression vectors / CD medium and a powerful CLD process (including the use ClonePix-FL cloning robot), the EMABling platform leads to gram-per-liter producing clones. Customers now can access to the EMABling platform to produce their own recombinant high-adcc mabs. Process Development and scale-up Process and scale-up are essential to obtain a competitive commercial product. To tackle this important issue, MAbLaunch TM s services cover adaptation of cell culture to serum-free media and/or media optimization for yield improvement. Upstream and downstream process optimizations are executed in state-of-the-art facilities. MAbLaunch TM s technological options include static or stirred vessels, hollow-fiber bioreactors or disposable bioreactors. Our in-house scientists and our network of experts will facilitate the of optimum cell culture conditions for each cell line. Our engineering staff have vast experience and the technical knowledge necessary to select the best chromatography and filtration systems, most appropriate buffers to establish optimal purification processes and viral clearance methods. MAbLaunch TM has a proven track record in tackling a number of challenging processes and scale-up, resulting in successful production of many antibodies and recombinant proteins. Manufacturing of clinical and commercial batches With its versatile range of production technologies, MAbLaunch TM can undertake GMP cell banking and production of biopharmaceuticals for Phase I to Phase III clinical trials and small to large-scale commercial supplies to meet the specific needs of our customers. In conjunction with these drug substance manufacturing capabilities, MAbLaunch TM (via the international network of Sanofi facilities) is able to offer access to significant fill & finish capacities for various finished dosage forms: pre-filled syringes liquid vials lyophilized vials cartridges From state-of-the-art facilities, MabLaunch TM will be in a position to supply clinical and commercial products on a worldwide basis. According to customer needs, associated services may range from standard transfer activities (scaling-up, analytical transfer, stability studies ) to specific support on technical issues, such as dosage form switch or compatibility studies, by experienced industrial and pharmaceutical teams.

5 MAbLaunch TM is your CMO Partner for biologics Key benefits : The advantages of large pharma combined with flexible CMO services Comprehensive and global offer of services for protein-based biopharmaceuticals, from mammalian cell line to optimization of cell culture conditions and process at small scale to preclinical, clinical and commercial manufacturing of drug substance and drug product An integrated, dual platform approach, which is fully adaptable to customer needs, offering the most suitable solution for each project, from small to large production quantities Extensive experience in evaluation, optimization and scale-up; avoiding unnecessary costs and delays in Successful production track records for pre-clinical, clinical and commercial supply to biopharmaceutical companies Seamless integration: unified project management and quality assurance systems Thorough regulatory and QA support, including full documentation and controls at all steps of and manufacturing Optimized entry cost and long-term cost effectiveness management Program management and regulatory support MAbLaunch TM understands the need to be at the forefront of s in the field of Quality Assurance and Regulatory Affairs as well as the importance of transferring this information to its clients. MAbLaunch TM has access to the expertise and experience of the Sanofi and LFB teams, in Quality Control, Quality Assurance, Regulatory and Program Management. Our quality systems are dedicated to providing high-value products and services which enable our customers to conduct a project with confidence. Each project is managed by a dedicated, experienced and multidisciplinary team who works in close collaboration with each customer to ensure that milestones are reached and that cost and timeline targets are met.

6 July 2013 Design and layout: PASAYA - Photographs: LFB & Sanofi, X LFB Biomanufacturing site Impasse des Chênes Rouges Alès cedex - France About LFB Group/ LFB Biomanufacturing LFB Group is a biopharmaceutical company, and the n 1 biotech French company. LFB Group is ranked as the fifth largest plasma-derived products player worldwide, and the third largest pharma company supplying drugs to hospitals in France. In the biotechnology field, LFB Group is developing monoclonal antibodies and a line of recombinant proteins using transgenic technology with GTC BioTherapeutics, a US based company. Founded in 1997, LFB Biomanufacturing is a fully integrated contract manufacturing organization based in Alès (southern France), specializing in GMP production of recombinant proteins and monoclonal antibodies using mammalian cell-based expression systems. Contacts MAbLaunch TM Sanofi site 9 Quai Jules Guesde Vitry sur Seine - France About Sanofi/BioLaunch Sanofi, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. BioLaunch building, Jacob Development & Jacob Production, is a major operation for Sanofi in France. An investment of nearly 200 million euros will give rise to the first cell culture biotechnology platform of the Group to produce monoclonal antibodies starting in This project is a core part of the conversion plan for the Vitry-sur-Seine site turning it into a comprehensive biotechnology platform that includes research, and production activities. Furthermore, Sanofi has decided to open this platform to other companies, on the basis of their or production needs. Patrick Haddad haddadp@lfb.fr Roland BELIARD beliard@lfb.fr Global: Philippe CLAVEL philippe.clavel@sanofi.com Europe: Arnaud Martin arnaud.martin@sanofi.com North America: John FULMER john.fulmer@sanofi.com Japan: Hikaru OHSAWA hikaru.ohsawa@sanofi.com