Sanofi’s Journey & Strategy for Continuous Processing for Small Molecules



27th September 2021 | 10:00am EST / 3:00pm GMT / 4:00pm CET | Flavien Susanne, Head of Chemical Development and Engineering at Sanofi and Sean Bermingham, Head of Formulated Products at PSE Ltd |WATCH FOR FREE

In the past decade, there has been a growing interest in the application of continuous processing in the pharmaceutical industry with 100s millions of investments and several products delivered to the market using this technology.
Continuous processing demonstrates several value propositions for the Pharmaceutical industry. Amongst them, we can name, access to better chemistry, product quality enhancement, reduction of CoGs but mostly speed to market where phase 3 to launch is drastically accelerated.
Sanofi R&D is building capacities to perform future GMP clinical batches using this technology. The first investment was completed last year, and we are in the process of expansion. It is a really changing time for science at Sanofi.
Sanofi is investing in modular concepts with a high capability of production of API and the ability of infinite reconfiguration. We are not only a thinking machine; to enhance our ability to always produce the best quality drugs for our patients, we are also implementing a digital twin system, tracking and controlling the quality of our product at any moment of time.
We are ready to meet the challenges of tomorrow and produce the new APIs to help patients.
Presented by Flavien Susanne, Head of Chemical Development Engineering at Sanofi

Flavien Susanne is a chemical engineer from the University of Normandy. He started his career at Pfizer in 2003 as part of the process development team working on the development of the flow team. Since Flavien, worked for Novartis, GSK, and more recently Sanofi.
Throughout the 17 years working within some of the most innovative Pharma, Flavien developed strong expertise in disruptive technology and CMC, leading new technology groups for the implementation of Pharma 4.0, including process intensification, big data, and filling following the QbD approach through modeling implementation.
Since 2020, Flavien has joined Sanofi as Head of Chemical Development & Process engineering, leading the implementation of continuous processing and digitalization as part of Synthetics
Followed by Sean Bermingham, Head of Formulated Products at PSE Ltd

Sean joined Siemens Process Systems Engineering in 2000, and has been Head of SPSE’s Formulated Products business unit since 2009. Prior to this role, he was SPSE’s Global Head of Consulting. Throughout his career at PSE he has acted as a Principal Consultant in over 30 crystallization and solids processing projects.
In his current role, he is responsible for strategic business development, software product development and services delivery for the pharma, food, consumer good, mining, specialty & agrochemical industries.
Sean is a leading figure in the development and adoption of mechanistic model-based tools for increasing R&D efficiency and managing risk in areas ranging from clinical trials to tech transfer and operations. He is the driver behind QbD 2.0, which focuses on improving the efficiency of QbD by reintroducing the “sound science” element of the original QbD definition.
He is one of the founders of the Systems-based Pharmaceutics Alliance with Bayer, GSK, Lilly, Pfizer, Roche and Sanofi. Sean was the lead for the £20.4m ADDoPT “Digital Design” Project with partners including AZ, BMS, GSK & Pfizer.
Sean is a Chemical Engineer with an MSc in Chemical Engineering and a PhD in crystallization from Delft University of Technology and an Executive MBA from Imperial College London.
Sponsored by Siemens Process Systems Engineering
 

 
About Siemens Process Systems Engineering
Siemens Process Systems Engineering (SPSE) is the world’s foremost provider of Advanced Process Modelling software and services to the process industries. Companies apply advanced process models within digital design and digital operations initiatives to explore the process decision space rapidly and effectively. This helps them to reduce uncertainty and make better, faster and safer formulation, process and product design and operating decisions based on deep scientific and process knowledge.
SPSE provides gPROMS family products built on its gPROMS® advanced modelling platform. These include the gPROMS FormulatedProducts modelling suite, which provides mechanistic models for active ingredient manufacture, formulation and product performance as well as specific capabilities for optimising solids and crystallization process design and operation. SPSE is committed to defining, developing and driving the adoption of next-generation process modelling software and workflows, and works in close collaboration with its major customers and selected R&D organisations to achieve this.
SPSE’s global customer base of Fortune 500 process industry companies and some 200 universities is served by operations in the UK, USA, UAE, Japan and Korea, and agencies in China and Taiwan.
About gPROMS FormulatedProducts
Built on SPSE’s gPROMS® advanced process modelling platform, the gPROMS FormulatedProducts modelling suite for optimising the formulation and manufacture of formulated products using mechanistic process and material models of unit operations – such as crystallization, spray drying and granulation – combined with in-vitro/vivo product performance models.
Use of SPSE’s technology and services results in faster innovation, more rapid formulation screening, improved process and product designs, enhanced operations, reduced risk, more effective R&D and experimental campaigns and better capture and transfer of corporate knowledge across the organisation.
Since 2013, the company has been pioneering the emerging science of Systems-based Pharmaceutics with Bayer, Eli Lilly, GSK, Pfizer, Roche and Sanofi.  SPSE was also the leader of the £20.4m AMSCI funded digital design ADDoPT project.
 


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