CPI and the University of Strathclyde have announced their strategic partnership with GSK and AstraZeneca has begun work on Grand Challenge 1, a project to develop an innovative continuous direct compression (CDC) platform at the new Medicines Manufacturing Innovation Centre. The platform will enable oral solid dosage medicines to be formulated more robustly and efficiently.
CDC is a continuous manufacturing process that allows greater process control than traditional batch-type pharmaceutical manufacturing methods, enabling rapid production of formulations at a range of scales. In addition, CDC offers shorter optimisation times than batch-type processes and therefore more efficient use of starting materials.
The aim of Grand Challenge 1 is to further build on this process efficiency by developing a digitally-twinned CDC platform and workflow, allowing scientists to understand and optimise their formulation process in digital space. This will reduce the amount of starting materials needed for optimisation and reduce the overall cost of the technology for the end-user.
Trial and error
The first stage of the project is to create a flexible plug-and-play development platform. This will involve adapting and improving existing CDC models, which are often inflexible and specific for individual equipment manufacturers. Novel process analytical technology (PAT) will also be integrated into this platform.
Professor Alastair Florence of the University of Strathclyde said: "The key innovation of a digital twin for the direct compression platform will radically cut down the amount of material needed to optimise formulations. It will allow companies to model their processes in digital space, providing a much deeper understanding of how APIs and excipients will perform, leading to a reduction in development times."
The project is receiving funding from UKRI, Scottish Enterprise and the consortium's industry partners, and is split into two phases. The development phase of the project is already underway at CMAC – the future manufacturing research hub within the University of Strathclyde. The aim is to have a development platform operational by Q3 2020. Following this initial phase, project work will be transferred to the MMIC in Glasgow upon the centre's completion in 2021.
Funded by UK Research and Innovation and Scottish Enterprise, the MMIC aims to ensure that the UK is a technological and innovation leader in pharmaceutical and fine chemical manufacturing, addressing some of the key challenges facing the industry. The facility will focus on the development of improved manufacturing processes, enabling a more agile, responsive medicines supply chain. The GMP-capable environment will enable new and disruptive technologies to be proven at scale, allowing the rapid adoption of next-generation processes that reduce risk, cut costs and save time.
Dave Tudor, Managing Director of the Medicines Manufacturing Innovation Centre at CPI said: "The strength of the open collaboration between CPI, GSK, AstraZeneca and the University of Strathclyde cannot be overstated; we are happy to be providing our strategic and technical support. The flexible platform developed at the centre through Grand Challenge 1 will be a national asset, helping pharmaceutical companies to develop formulations faster and at a reduced cost."