New £20.4m project set to transform UK pharmaceutical development and manufacturing

Britest is playing a key role in a newly launched major collaborative project that is set to transform the UK pharmaceutical industry by enabling the manufacturing processes of the innovative medicines of the future to be designed digitally.

The ADDoPT (Advanced Digital Design of Pharmaceutical Therapeutics) project addresses a key challenge for the pharmaceutical industry; getting new innovative medicines to market in the quickest and most cost-effective way possible to ensure access for patients. The collaboration will pursue this goal by developing and implementing advanced digital design techniques that eliminate non-viable drug candidate formulations as early as possible, streamlining design, development and manufacturing processes.

‘Digital design’ combines research insight and mechanistic modelling to provide links between raw materials, formulation, manufacturing processes and drug product quality. It spans all operations, processes and procedures during the development and manufacture of medicines, and their in vivo application.

ADDoPT draws on the expertise of UK technology and academic leaders in the field of digital design concepts including Britest, whose specialist tools and expertise in fundamental understanding of manufacturing processes will be applied to industrial case studies provided by the four major pharmaceutical companies (Pfizer, GSK, AstraZeneca and Bristol-Myers Squibb) within the consortium. A key objective is to achieve better design and scale-up for robust products and processes through more targeted future experimentation and better understanding of risk. Britest’s extensive experience in knowledge transfer, dissemination and exploitation will also ensure that learning from the ADDoPT project is translated for application in other high value manufacturing sectors.

ADDoPT builds on UK excellence in big data, mechanistic modelling, process optimisation and control to establish a highly competitive UK knowledge value supply chain for the pharmaceutical sector that will seek to:

• protect UK drug manufacturing and support future growth
• encourage reshoring of existing pharmaceutical production
• contribute to job creation and safeguarding in the pharmaceutical supply chain
• enhance UK skills and capabilities through the training of operators and scientists in new design and control tools and methodologies
• get new innovative medicines to market as efficiently as possible to ensure access for patients.

For Britest, the project represents not just an opportunity to strengthen the pharmaceutical industry, but a chance to deepen our understanding of how Britest's powerful qualitative process insight methods can work in tandem with quantitative mechanistic models to overcome real world manufacturing limitations and drive innovation.

Britest's Technical Director Mark Talford said,

We believe this project will have lessons for any manufacturer who wants to drive their product development and process control by understanding what is going on at molecular, material, process and product scales.

A project web site will be established shortly at www.ADDoPT.org. In the meantime, some further details on the project and its background can be found here.