Pharmaceuticals
Grand Challenge 1: opportunities for partnership and investment

By Dr John Robertson Senior Research Fellow University of Strathclyde

Dr John Robertson, Senior Research Fellow at the University of Strathclyde, describes how the ‘Grand Challenge 1’ projec

Dr John Robertson, Senior Research Fellow at the University of Strathclyde, describes how the ‘Grand Challenge 1’ project being run by the Medicines Manufacturing Innovation Centre, a collaboration between the Centre for Process Innovation (CPI), UK Research and Innovation, Scottish Enterprise, and founding industry partners, AstraZeneca and GSK, is working on new pharmaceutical process technologies to meet the real need to reduce the costs of drug development.
 
A rapidly ageing population and the eye-watering cost of drug development are placing the pharmaceutical and health care sectors under unprecedented strain. There is a critical need to reduce R&D expenditure while also improving the ways in which health care systems provide treatment to the growing proportion of elderly patients. This is a highly complex challenge to overcome and part of the solution involves fundamentally changing the way that pharmaceutical manufacturing currently operates.
 
Traditional batch manufacturing processes often require long optimization times and are not flexible enough to respond to fluctuating drug demand or to deliver personalized medicines. However, developing new and future-proofed solutions requires investment and expertise not available within any one government, organization or private company. Instead, representatives of the entire value chain must come together to work as part of bold new models for partnership and investment, which is the remit under which CPI’s Medicines Manufacturing Innovation Centre was founded. The centre, based in Renfrewshire, UK, is bringing together government, academia and industry to develop agile technology platforms. This will eliminate inefficiencies in the pharmaceutical supply chain and lower the cost of drug development.

 

      CPI’s existing labs in the North East of England 1.jpg

 

 

 

 

 

 

‘CPI’s existing labs in the North East of England’.

 

The Medicines Manufacturing Innovation Centre’s founding industry partners, AstraZeneca and GSK, are two of the UK’s leading pharma companies and this is the first time they have combined their expertise to co-develop new technology. The centre is also receiving valuable input from its academic partner, the University of Strathclyde, as well as a host of SMEs from across the supply chain as part of the Medicines Manufacturing Innovation Partnership (MMIP).Funding support is being provided by Scottish Enterprise and UK Research and Innovation. Although the future of pharma manufacturing will be challenging, ambitious projects at the new centre such as Grand Challenge 1 are demonstrating the tremendous opportunities on offer for those bold enough to get involved.

 
This time it’s personal
 
Grand Challenge 1 is one of the Medicines Manufacturing Innovation Centre’s flagship projects and aims to improve current production methods for oral solid drug formulations. Inefficient and inflexible manufacture of solid drugs was a key issue identified after extensive consultation with companies across the pharmaceutical supply chain. The collaboration at CPI’s new centre will solve this by developing a digitally-twinned continuous direct compression (CDC) manufacturing platform: CDC provides finer process control compared with batch methods, enabling the scalable and rapid production of the highly tailored drug formulations that are required for simple, cost-effective, agile manufacturing processes.
 
The project is well underway, with the CDC platform’s digital twin currently being developed at the University of Strathclyde.This is a key innovation, as it will enable pharmaceutical manufacturers to optimize their formulations in digital space, drastically reducing the time and raw materials required during this process.The expertise offered by the University of Strathclyde within the realms of pharmaceutical manufacture and characterization has been crucial in making this ambitious project a success. In addition, the centre’s industry partners are contributing their extensive knowledge of pharmaceutical manufacturing and are helping to establish the business case for this new technology and, once completed, Grand Challenge 1 will offer an open-access platform for companies developing new formulations.
 
Successful collaboration relies upon every partner having the opportunity to make its voice heard and the support to meet its unique objectives. This requires strong and open communication between partners, exhibiting levels of transparency not often seen within the industry. The involvement of two competitors in Grand Challenge 1, AstraZeneca and GSK, makes honest communication even more important, but the value it is adding to both companies makes this radical model of collaboration well worth the effort.
 
From challenge to opportunity
 
A recent workshop held at the University of Strathclyde with industry experts, equipment suppliers, government and academia mapped out the future of the Medicines Manufacturing Innovation Centre. Key issues in the pharmaceutical supply chain were identified and a shortlist of proposals for future grand challenges was created. This included a clinical direct compression facility as well as a platform for particle design and delivery.
 
The issues being faced by the pharmaceutical industry can only be solved with heavy investment in new manufacturing technologies and strong partnerships to develop them together. By joining forces, stakeholders in the industry can co-develop the manufacturing processes that will herald the pharmaceutical development and manufacturing supply chain of the future.