CEPiA WHITE PAPERS
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
PRODUCTION OF BIOLOGICS (therapeutic proteins, fusion proteins, mAbs, Fabs) OUT OF TRADITIONAL EXPRESSION SYSTEMS Within Sanofi Industrial Affairs we can offer external partners looking for a CDMO / CMO (Contract Dupt & Manufacturing Organization/Contract Manufacturing Organization) the excellence of our industrial network to produce custom APIs. We are able to provide customers GMP material from clinical stage to commercial scale. Since the 60’s Sanofi has been a leader in the field of large-scale fermentation of small molecules and in the 80’s with production of recombinant insulins. Refolding and glycosylation pattern specification are critical for therapeutic efficacy of these proteins, including enzymes. It happens that traditional expression systems such as fermentation and mammalian cell culture cannot reach specifications and that variability of such parameters is observed from a batch to another. Therefore, Sanofi Industrial Affairs has been interested in other expression systems. Production of therapeutic proteins expressed in milk of transgenic animals and in plants might be an alternative. Aramon, an industrial site located in southeast France, has been involved with production of therapeutic proteins since the early 80s producing HGH (Human Growth Hormone) via E. Coli fermentation and associated DSP. In addition, Aramon has produced Avidin from egg whites and is still producing Rasburicase (Urate Oxidase) via Saccharomyces cerevisae fermentation.
www.cepia-sanofi.com
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
In 2009, Sanofi IA decided to invest in the implementation of a state of the art platform to produce therapeutic proteins to support external biopharma projects. Investments were made to expand the range of technologies and more specifically to purify animal and plant derived proteins. It is too early to assess the number of APIs that will be produced via these technologies but Sanofi is convinced that they cannot be ignored. Indeed with the increasing pressure on prices, with potential pandemic diseases and with the growing rate of population in emerging countries, production of complex APIs using milk of transgenic animals or plant expression systems may become breakthrough. The success of the investments can be seen in the 2,000M2 state of the art platform implemented in Aramon. Custom APIs have been commercially produced from plants, natural materials (e.g. eggs, seeds) and milk. The versatility, the capacity and the skills enable Sanofi to support projects from early stage of development to commercial scale. The level of efforts required to perform process and analytical transfer is often underestimated. Therefore we have built and trained teams to address the complexity of all projects. Sanofi’s teams are the key for the successful transfer of processes and analytical methods to meet customers’ project and timeline needs. Aramon team has demonstrated achievement with 5 process and analytical transfers over the last 4 years.
www.cepia-sanofi.com
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
Offering CMO services from a large pharma companies is a hurdle? Definitively it’s an advantage and brings value to customers projects. Sanofi’s preferred biotechnology customers are mainly innovative biopharmas companies about to launch and commercialize their first marketed compound. They cannot afford delay or technical/quality uncertainty. Sanofi does its best to speed to market innovative products while taking into consideration the budgetary constraints of customers or the regulatory requirements of health authorities. Utilizing the benefits of Sanofi’s bioproduction network, and specifically those provided by the Aramon site, partners can take advantage of Sanofi’s success. Numerous compounds have been approved and are on the market. Each of these products has been audited by the health agencies (EMA, FDA, PMDA, ANVISA…). Aramon belongs to the Bio-network and relies on the support of global transversal functions, quality, procurements, engineering, legal, IP and patents which brings value to partners’ projects. Sanofi has more than 120 own branded compounds on the market and 200 APIs sold to customers outside the group. Our willingness to offer a tool box of technical, quality and regulatory support to BLA submissions has led to successful launches. Each customer has unique needs. For this reason we offer a customized package where the customer can pick services corresponding to the specific project requirements and budget. CMO activity is not the core business but definitively belongs to the industrial strategy of Sanofi. We adapt our organization to offer customized reliability and flexibility. Due to the fact that third party business was integrated several decades ago, Sanofi is determined to manage challenging projects from its partners. Our recent experience of CMO activity has shown that working with a large pharma company brings value during discussions with venture capital investors or with other pharma companies interested in an in-licensing agreement. The lack of reliability or robustness of a process, including analytical methods, can result in failure to raise funds or to find partners for the compound. Sanofi’s has a long history of managing its internal portfolio as well as external customer projects. Sanofi is organized to avoid conflict of interests with its third party business. Industrial activities are disconnected from internal R&D and are not operated from the same sites. Transparency and proactivity are keys in CMO business. It is our philosophy. Before the signature of supply agreement customers are informed about potential conflicts of interest. Access to notebook and other important information is secured with restricted password access. The financial stability of companies like Sanofi is an asset for customers. We have been here for a while so we will be here for your success.
www.cepia-sanofi.com
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
Sanofi & Third Party business at a glance : - 200 successful CEPiA collaborations. - More than 200 APIs available and sold in 80 countries. - 30% of Chemistry and Biotechnology industrial activities in Sanofi Industrial Affairs network. Sanofi Aramon, a major player in the manufacturing and development of biologics for third parties. This site, located in southern France, is : - Recognized as an expert for plant extraction for pharmaceutical purposes. - Center of excellence to develop and/or produce your biologics . o Scale from the gram to several tens of kg/year. o Supply of GMP material for clinical to commercial supply. - Has an excellent proven track record with health authorities (including FDA, ANSM, PMDA, …). - Has a highly skilled workforce (more than 60 people dedicated to this activity). - Produces several therapeutic proteins through fermentation or extraction from natural material (plants and animals). - Has a Process Development team on site which has a long experience with process improvement and scale-up if required.
www.cepia-sanofi.com
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
Sanofi is convinced that intensive collaboration with customers is crucial, and adapts the organizations frequently to meet customers’ needs. We have demonstrated success over the 5 past years with several robust process transfers and the associate analytical assays critical to support the process transfer. Aramon Quality Systems have been implemented with the same high quality standards maintained throughout Sanofi. To conclude: CEPiA Sanofi organization has the strong willingness to establish supply partnerships with: - Biopharma and start-up companies - Cosmetic industries - Industrial enzyme companies In order to reach the Sanofi objective of providing third party contract services and supporting our customers’ projects, we deliver a complete service offering : - Bioanalytical development - Process development and scale-up - Process / Analitical transfer and validation - Equipment design & qualification - Regulatory support - Project management - Clinical or commercial product supply (API & DP)
[email protected]
www.cepia-sanofi.com
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
PRODUCTION OF BIOLOGICS (therapeutic proteins, fusion proteins, mAbs, Fabs) OUT OF TRADITIONAL EXPRESSION SYSTEMS Within Sanofi Industrial Affairs we can offer external partners looking for a CDMO / CMO (Contract Dupt & Manufacturing Organization/Contract Manufacturing Organization) the excellence of our industrial network to produce custom APIs. We are able to provide customers GMP material from clinical stage to commercial scale. Since the 60’s Sanofi has been a leader in the field of large-scale fermentation of small molecules and in the 80’s with production of recombinant insulins. Refolding and glycosylation pattern specification are critical for therapeutic efficacy of these proteins, including enzymes. It happens that traditional expression systems such as fermentation and mammalian cell culture cannot reach specifications and that variability of such parameters is observed from a batch to another. Therefore, Sanofi Industrial Affairs has been interested in other expression systems. Production of therapeutic proteins expressed in milk of transgenic animals and in plants might be an alternative. Aramon, an industrial site located in southeast France, has been involved with production of therapeutic proteins since the early 80s producing HGH (Human Growth Hormone) via E. Coli fermentation and associated DSP. In addition, Aramon has produced Avidin from egg whites and is still producing Rasburicase (Urate Oxidase) via Saccharomyces cerevisae fermentation.
www.cepia-sanofi.com
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
In 2009, Sanofi IA decided to invest in the implementation of a state of the art platform to produce therapeutic proteins to support external biopharma projects. Investments were made to expand the range of technologies and more specifically to purify animal and plant derived proteins. It is too early to assess the number of APIs that will be produced via these technologies but Sanofi is convinced that they cannot be ignored. Indeed with the increasing pressure on prices, with potential pandemic diseases and with the growing rate of population in emerging countries, production of complex APIs using milk of transgenic animals or plant expression systems may become breakthrough. The success of the investments can be seen in the 2,000M2 state of the art platform implemented in Aramon. Custom APIs have been commercially produced from plants, natural materials (e.g. eggs, seeds) and milk. The versatility, the capacity and the skills enable Sanofi to support projects from early stage of development to commercial scale. The level of efforts required to perform process and analytical transfer is often underestimated. Therefore we have built and trained teams to address the complexity of all projects. Sanofi’s teams are the key for the successful transfer of processes and analytical methods to meet customers’ project and timeline needs. Aramon team has demonstrated achievement with 5 process and analytical transfers over the last 4 years.
www.cepia-sanofi.com
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
Offering CMO services from a large pharma companies is a hurdle? Definitively it’s an advantage and brings value to customers projects. Sanofi’s preferred biotechnology customers are mainly innovative biopharmas companies about to launch and commercialize their first marketed compound. They cannot afford delay or technical/quality uncertainty. Sanofi does its best to speed to market innovative products while taking into consideration the budgetary constraints of customers or the regulatory requirements of health authorities. Utilizing the benefits of Sanofi’s bioproduction network, and specifically those provided by the Aramon site, partners can take advantage of Sanofi’s success. Numerous compounds have been approved and are on the market. Each of these products has been audited by the health agencies (EMA, FDA, PMDA, ANVISA…). Aramon belongs to the Bio-network and relies on the support of global transversal functions, quality, procurements, engineering, legal, IP and patents which brings value to partners’ projects. Sanofi has more than 120 own branded compounds on the market and 200 APIs sold to customers outside the group. Our willingness to offer a tool box of technical, quality and regulatory support to BLA submissions has led to successful launches. Each customer has unique needs. For this reason we offer a customized package where the customer can pick services corresponding to the specific project requirements and budget. CMO activity is not the core business but definitively belongs to the industrial strategy of Sanofi. We adapt our organization to offer customized reliability and flexibility. Due to the fact that third party business was integrated several decades ago, Sanofi is determined to manage challenging projects from its partners. Our recent experience of CMO activity has shown that working with a large pharma company brings value during discussions with venture capital investors or with other pharma companies interested in an in-licensing agreement. The lack of reliability or robustness of a process, including analytical methods, can result in failure to raise funds or to find partners for the compound. Sanofi’s has a long history of managing its internal portfolio as well as external customer projects. Sanofi is organized to avoid conflict of interests with its third party business. Industrial activities are disconnected from internal R&D and are not operated from the same sites. Transparency and proactivity are keys in CMO business. It is our philosophy. Before the signature of supply agreement customers are informed about potential conflicts of interest. Access to notebook and other important information is secured with restricted password access. The financial stability of companies like Sanofi is an asset for customers. We have been here for a while so we will be here for your success.
www.cepia-sanofi.com
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
Sanofi & Third Party business at a glance : - 200 successful CEPiA collaborations. - More than 200 APIs available and sold in 80 countries. - 30% of Chemistry and Biotechnology industrial activities in Sanofi Industrial Affairs network. Sanofi Aramon, a major player in the manufacturing and development of biologics for third parties. This site, located in southern France, is : - Recognized as an expert for plant extraction for pharmaceutical purposes. - Center of excellence to develop and/or produce your biologics . o Scale from the gram to several tens of kg/year. o Supply of GMP material for clinical to commercial supply. - Has an excellent proven track record with health authorities (including FDA, ANSM, PMDA, …). - Has a highly skilled workforce (more than 60 people dedicated to this activity). - Produces several therapeutic proteins through fermentation or extraction from natural material (plants and animals). - Has a Process Development team on site which has a long experience with process improvement and scale-up if required.
www.cepia-sanofi.com
CEPiA WHITE PAPERS
PLASMIDS AND DNA VACCINES
ENZYMES
FRAGMENTS OF ANTIBODIES (Fabs) PROTEINS POLYCLONAL ANTIBODIES
BACTERIA & YEASTS
Sanofi is convinced that intensive collaboration with customers is crucial, and adapts the organizations frequently to meet customers’ needs. We have demonstrated success over the 5 past years with several robust process transfers and the associate analytical assays critical to support the process transfer. Aramon Quality Systems have been implemented with the same high quality standards maintained throughout Sanofi. To conclude: CEPiA Sanofi organization has the strong willingness to establish supply partnerships with: - Biopharma and start-up companies - Cosmetic industries - Industrial enzyme companies In order to reach the Sanofi objective of providing third party contract services and supporting our customers’ projects, we deliver a complete service offering : - Bioanalytical development - Process development and scale-up - Process / Analitical transfer and validation - Equipment design & qualification - Regulatory support - Project management - Clinical or commercial product supply (API & DP)
[email protected]
www.cepia-sanofi.com
