The Engineering and Physical Sciences Research Council has awarded £4.5 million (US$5.8m) in a Prosperity Partnership to address challenges in medicines manufacturing. The Centre for Process Systems Engineering (CPSE) from Imperial College London will lead the collaboration with Eli Lilly and Company.
The CPSE involves academics from the Departments of Chemical Engineering, Computing and Chemistry and the Department of Chemical Engineering.
The project will strengthen the existing academic-industrial collaboration between Imperial College London, University College London and Eli Lilly and Company, and position the UK at the cutting edge of expertise and innovation in the manufacturing of high-value synthetic drugs.
Manufacturing new medicines
Over the last few years, the partners have been tackling scientific hurdles to the manufacturing and the delivery of key medicines, focusing on small molecules. New medicines are increasingly based on larger molecules, such as peptides, which are much harder to manufacture.
This new project will enable the teams to extend their ambitious research programme to help overcome challenges in the manufacture and delivery of peptide drugs.
The main objectives when developing a manufacturing process for new medicines are to produce an effective, high-quality medicine in sufficient quantities and without interruption of supply to patients who depend on the drug. One of the key challenges that needs to be overcome to achieve this is how to increase the efficiency of the production process to ensure that the majority of the raw materials are converted into drugs rather than waste.
One of the key challenges is how to increase the efficiency of the production process to ensure that the majority of the raw materials are converted into drugs rather than waste
Another challenge is ensuring that whilst a high yield is obtained, the final drug product is of high purity and easily absorbed by the body.
Using current manufacturing technologies and relying on a large number of time-consuming and expensive experiments to develop a manufacturing process results in a delay between the discovery of a new peptide drug and it being commercially available.
Digital decision-making
Professor Claire Adjiman (Centre for Process Systems Engineering), Dr Salvador García-Muñoz (Eli Lilly) and Dr Jeffery Richardson (Eli Lilly and Company) will lead a multi-disciplinary team of researchers to address the most pressing scientific challenges that impact all the key steps in the manufacturing of drugs: chemical synthesis, purification and isolation of the drug molecule, and its combination with other ingredients to turn it into an effective medicine.
They will do this by using a unique combination of a small number of targeted experiments, digital decision-making approaches and artificial intelligence to enable the creation of modern state-of-the-art medicines manufacturing processes. Among the technologies, the team will develop is a novel approach to liquid-phase synthesis of peptides, which has the potential to be more effective than current technologies such as solid-state synthesis or bioprocessing.
Adjiman said: "We are very excited to work with Eli Lilly on such a comprehensive and ambitious research programme to tackle some of the toughest challenges in medicines manufacturing. This is a unique opportunity to make fundamental scientific advances that can have a direct impact on manufacturing at Eli Lilly and across the pharmaceutical industry, with the aim to bring medicines to patients more quickly."
Academic and industrial collaboration
The five-year project will combine expertise from academia and the pharmaceutical industry to break down barriers to the cost and time-effective manufacturing of synthetic drugs.
To achieve this, they will develop advanced techniques for drug substance crystallisation and purification, advanced manufacturing and stability analysis of drug products, and cross-cutting systems engineering methods.
García-Muñoz said: "This grant empowers Lilly to pursue fundamental research in drug development that will accelerate the timelines to get new medicines to the public. Our academic partners' unique ability to apply systems engineering approaches is a key differentiator and we are confident about the success of the research programme."
"This grant creates a diverse research ecosystem enabling Lilly scientists, professors and students to learn from each other and together tackle the very challenging technical problems we face to develop safer and more effective medicines. We are most excited for this opportunity and what it means for the patients that we serve," García-Muñoz added.