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Bernal Institute Research Forum

Tue, 11 Jul 2017

Date: Tuesday, July 11, 2017
Time: 13:30 to 14:30
Duration: One hour
Contact: Joan O'Riordan -
Location: MSG-025 MSSI Building Extension, Ireland

Dr Sean Bermingham, Process Systems Enterprise Ltd (PSE).

Integrated Digital Design of Formulated Products and Their Manufacturing Processes: Illustrated using Industrial Pharma Case Studies

In order to reduce iterations between on the one hand the design of formulated products (focusing on quality attributes) and on the other the design of their manufacturing processes (focusing on manufacturability, yield and selectivity), it is proposed to design these in a holistic manner. Together with Eli Lilly and Pfizer, PSE is a founding member of the Systems-based Pharmaceutics Alliance, which has recently welcomed GSK and Roche as members. The SbP Alliance is accelerating development, adoption and acceptance of tools required for the holistic design of drug products and their manufacturing processes. In this talk the SbP vision will be briefly described. Subsequently industrial case studies, covering areas such as crystallization, granulation and oral absorption, will be presented to demonstrate progress already made. Finally, an overview will be given of ongoing developments in collaboration with academia.

Sean joined PSE in 2000, and has been Head of PSE’s Formulated Products business unit since 2010. Prior to this role, he was PSE’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, 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 Eli Lilly, GSK, Pfizer and Roche. This Alliance is developing and promoting a holistic approach to the development and optimization of drug formulations, drug manufacture processes and drug delivery. Sean is the lead for the £20.4m ADDoPT “Digital Design” Project with AZ, BMS, GSK & Pfizer, Britest, Perceptive Engineering, CCDC, STFC Hartree, University of Leeds, University of Cambridge and University of Strathclyde. He is a board member of CMAC, the Centre for Continuous Manufacturing and Crystallization at Strathclyde University, and co-director of the RCPE-PSE Centre of Excellence for Pharmaceutical Formulation & Manufacture. 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.


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