Medicines Manufacturing Innovation Centre project to deliver Just in Time clinical trials
The Medicines Manufacturing Innovation Centre, a collaboration between CPI, University of Strathclyde, UK Research and Innovation, Scottish Enterprise, AstraZeneca and GSK, has reached the next milestone in delivering automated Just in Time clinical trials.
The Medicines Manufacturing Innovation Centre aims to develop the medicines manufacturing processes of the future, enabling a more agile, responsive medicines supply chain through improved manufacturing processes. It will enable new and disruptive technologies to be proven at scale in a GMP environment; a capability which other innovation centres are unable to offer. This will allow the rapid adoption of next-generation processes that reduce risk, cut costs and save time.
The initial focus of the centre will be to deliver two ‘Grand Challenges’, with Grand Challenge 1 looking into how oral solid dosage medicines can be produced more robustly and efficiently utilising continuous direct compression. Grand Challenge 2 is focused on how these medicines can then be delivered to patients with minimal waste and maximum speed, through the use of Just in Time (JIT) manufacture & supply capabilities.
Work is currently underway to deliver Grand Challenge 2, with designs for the automated platform being finalised. Integration of the Real Time Release platform also requires software package specifications which are currently being finalised. It is expected that the automated platform and data integration will be delivered in the second quarter of 2021, along with completion of the Medicines Manufacturing Innovation Centre building in Glasgow.
This is an open-innovation project supported by the Medicines Manufacturing Industry Partnership and funded by collaborative partners GSK and AstraZeneca. The Centre is also supported by a £13 million investment from UK Research and Innovation through the Industrial Strategy Challenge Fund (ISCF), along with £15 million Scottish Government investment via Scottish Enterprise.
The automated platform will generate real-time quality data and produce GMP clinical stock for near-term forecasted demand and/or ‘real-time’ individual patient orders. The ambition is that this infrastructure will eventually enable the manufacture and release of medicine to patients in real time. The combination of these components will enable the: acceleration of investigational medicine availability; the rapid adaption of the supply strategy driven by evolution of clinical study requirements; plus a significant reduction in valuable wasted materials.
Colin Mear Engineering Ltd (CME), based in Somerset, UK have recently been awarded the contract to deliver the JIT automation platform. Once complete the automation platform will integrate with the real time ordering and release software platforms being co-developed within the Centre. With a contract and purchase order now agreed, the next stages of the project will focus on equipment construction aligned to the overall engineering objectives and the hiring of scientists, engineers and technicians to support the project.
Dave Berry, Project Lead at CPI, said: “We are incredibly lucky to be working with some excellent people from AZ and GSK who have provided us with the opportunity to integrate their significant expertise across the relevant business units with our own. This is one of the best collaborative projects I have been involved in. The partners are contributing financially, but they’re also bringing ideas, people, energy and access to their considerable facilities and equipment infrastructure. It’s very exciting to be able to tap into this expertise across the clinical supply chain to deliver on Grand Challenge 2 and prove that real time release is possible.”
Dave Tudor, Managing Director of the Medicines Manufacturing Innovation Centre at CPI said: “I am delighted with the progress that has been made so far on this collaborative project and am looking forward to the next stage of delivery. This activity is a perfect example of what the centre is setting out to achieve, connecting industry to overcome barriers associated with medicine manufacture, making healthcare more affordable for providers and patients alike.”
Comparable development is taking place in Grand Challenge 1, and throughout the other deliverables of the Medicines Manufacturing Innovation Centre. If you would like to join the Centre as a delivery partner and get involved with the project, please get in touch.