LONDON--Process Systems Enterprise (PSE), the Advanced Process Modelling company, and the Research Center for Pharmaceutical Engineering GmbH (RCPE), an independent R&D Centre specialised in Advanced Manufacturing Science and Pharmaceutical Engineering, today announced the formation of a Centre of Excellence (CoE) aimed at bringing combined model-based analytical technology and services to pharmaceuticals manufacturers.
The CoE for Pharmaceutical Formulation & Manufacture provides a single-point service for material characterisation, predictive modelling and process optimisation. It aims to help pharmaceutical companies accelerate the development of drugs and their manufacturing processes, from R&D through tech transfer to commercial manufacturing. Further detail on the CoE and the services it provides to pharmaceutical drug development is also outlined in this webinar.
The combined, integrated service will provide solutions that help pharma organisations to explore the formulation and manufacturing decision space rapidly and effectively using mechanistic modelling approaches. By combining models and experimental data to provide an accurate predictive capability for drug products and their manufacture the CoE will be able to help companies accelerate formulation decisions and design more effective and efficient manufacturing processes.
PSE provides the gPROMS FormulatedProducts modelling suite, which contains mechanistic models for drug substance manufacture, drug product manufacture and in-vitro/vivo product performance as well as specific capabilities for optimising product and process design. The company pioneered the emerging science of Systems-based Pharmaceutics, and is the leader of the £20.4m digital design ADDoPT project.
RCPE performs cutting-edge research in process and product optimisation to help create competitive advantage through development of novel products and production processes, with a key focus being new drug delivery systems. The company has extensive experimental and processing facilities in Graz, Austria that include analytical science, material science, PAT and pharmaceutical engineering capabilities, and has significant experience in modelling and simulation of fluid and granular/powder systems.
Massimo Bresciani, Executive Director for Scientific Operations & BD of RCPE, says “we are very excited about the Centre of Excellence. It gives us a truly unique capability and allows us to provide the most modern set of integrated tools and services for product and process design and development. By using both parties’ experience we can, for example, help pharma companies speed up tech transfer and late phase filings”.
Sean Bermingham, VP for PSE’s Formulated Products Business says “the combination of mechanistic models and targeted experiments is a powerful approach that helps pharma companies accelerate drug substance and product development, quantify and manage risk, and design and scale-up robust manufacturing processes. We very much look forward to working with RCPE to provide a holistic service that covers all these aspects”.
Watch this webinar for more information on the CoE.