The aim of this project, which is due for completion by April 2018, is to deliver methodology and best practice guidance for implementing models to support the development and industrialisation of manufacturing processes for particulate products.
Paul Scott, AstraZeneca, said “Creating this framework will enable Pharmaceutical Development groups across industry to more effectively implement modelling approaches for the design of better pharmaceutical products and processes, facilitating rapid product development and making these approaches more accessible to the pharmaceutical sciences community.”
Ultimately, the implementation of these models in industry has the potential to increase the speed of development and/or improve product quality, whilst reducing formulation development costs and delivering sustainability improvements.
The project involves collaboration with eight partners: AstraZeneca, Pfizer, Johnson Matthey, Proctor & Gamble, the University of Sheffield, the University of Edinburgh, PSE and DEM Solutions (EDEM).
Richard LaRoche, CEO at EDEM said: “Working alongside key industrial and academic partners is key to this innovative project and we are delighted to be an integral contributor to this. Modelling tools such as the Discrete Element Method (DEM) and Population Balance Modelling (PBM) provide key insights into manufacturing processes and help improve their understanding, which can result in increased process efficiency and significant cost savings.”
“This project will help transfer knowledge from academia to industry and accelerate adoption of particle modelling technology.”
Particulate products make up approximately 80% of chemical products across a wide range of industry sectors, from pharmaceuticals, consumer goods, food and beverages to paints, agriculture, and speciality chemicals, plus many more.1
There is an increasing demand for increased productivity, which can be achieved through predictive design via the development of robust models for simpler formulation of particulate products.
The consortium will be developing a methodology for industry to implement the best available models, using granulation as an exemplar process.
This is a demanding area of research and such knowledge in formulations and processing could lead to vast improvements in particulate products.
The aim of the project is the establishment of a commercial service, to be housed at CPI’s National Formulation Centre in the North East, to support data generation for the industrial implementation and validation of future models.
Graeme Cruickshank, Director of the National Formulation Centre at CPI, said: “We are proud to be working with world-leading partners on the development and implementation of robust models for simpler formulations to significantly improve the quality of particulate products. The implementation of these models will dramatically increase the speed of development to drive productivity within the UK formulation sector.”
This will include expertise and experimental manufacturing studies to facilitate model development and validation using real product examples.
The consortium will develop prototype and production ready models to support the development of products manufactured by wet granulation.
The models are expected to be robust, user-friendly and focused on delivering the output product specifications, given a limited number of measured input parameters and will ultimately simplify innovation efforts for the industry.
The project is a highly challenging task requiring integration of experimentation with modelling and coupling appropriate models at multiple scales.
Jim Lister, University of Sheffield, said: “This is an exciting project bringing state-of-the-art research to give real impact in industry. The models we are developing are part of a transformation of the industry from empirical to model-driven design of particulate processes. It is particularly satisfying to work with a team consisting of university researchers, manufacturing companies and software companies on this project.”
This multi-scale particle approach will use discrete element methods to provide particle level physics and inform the large-scale population models, which will provide a scale-up methodology for full-scale industrial processes.
Dr Luis Martin de Juan, P&G, said: “This programme set up the foundations of the next generation of process granules modelling. Expertise and experience from the academics and industrialist fit very well to achieve the ambitious goals of the programme.”
- H. Merkus and G. Meesters “Particulate Products,” Cham: Springer International Publishing, 2014.