In response to the growing need for sustainable practices in pharmaceutical manufacturing, our project aims to transform the industry by incorporating cutting-edge technology and data-driven approaches to create eco-friendly factories for the future. Our vision is to revolutionise pharmaceutical manufacturing by integrating robotics and automation, along with advanced data science and artificial intelligence (AI) approaches. This initiative seeks to develop next-generation manufacturing methods and improve downstream processing to promote circularity in the industry, ultimately reducing environmental impact and meeting the demand for innovative and sustainable practices.
The pharmaceutical industry has been slower to adopt robotics and automation compared to other sectors. Our goal is to change this by increasing the use of collaborative robots (cobots) and automation in both our research and development labs and manufacturing facilities. By integrating robotics, we will enhance precision and efficiency, leading to reduced energy consumption and waste compared to traditional methods. Additionally, we plan to develop self-optimising reactors using data-driven insights to facilitate rapid scale-up, reducing material and time requirements for process development.
In addition to robotics and automation, our project will focus on advancing next-generation pharmaceutical manufacturing techniques. Continuous processing methods offer sustainability benefits, and we aim to overcome associated challenges by developing new reactor types that can accommodate a wider range of drug substance and product processes. This will include downstream processes for continuous purification and waste management, including the exploration of advanced technologies such as membrane-based systems to minimise waste and energy consumption while ensuring the efficient extraction of high-quality pharmaceutical products from complex mixtures.
Our future factory will use data-driven approaches and AI based on comprehensive data collection through Process Analytical Technologies (PAT) and analytical science to reduce our environmental impact, improve efficiency, and increase automation in manufacturing. This means creating predictive models to optimise production planning, enhance quality control, and carry out maintenance before issues arise. Putting data at the heart of our future factory allows us to continuously monitor and improve processes, ensuring the best production results and efficient use of resources.
We are collaborating with large pharmaceutical companies, small and medium-sized enterprises, and academic institutions, all of which possess the necessary expertise to deliver groundbreaking technologies. Together, we aim to ensure that the outputs of this project are adopted across the medicines manufacturing sector, thereby reducing emissions and minimising waste.
The project will establish the RESILIENCE Centre of Excellence for UK Medicines Manufacturing Skills by bringing together the leading regional training providers. There is an urgent need for training and outreach to support the UK life sciences workforce and there is also an opportunity, as a major report states that the sector has the potential to create approximately 133,000 jobs by 2030, through replacement and growth \[ScienceIndustryPartnership\].
The UK has a long and proud history of medicines discovery and manufacturing. From penicillin to monoclonal antibodies to revolutionary cell and gene therapies, the UK has always shown the world great leadership. During the Covid-19 global pandemic, one of the first vaccines to emerge was from Oxford University scientists.
The UK now faces a critical skills shortage in key areas of medicines manufacturing, particularly manufacturing, analytics/quality, process development and regulatory. Added to this, medicines manufacturing technology is rapidly evolving, bringing an increased need for skills in digital, computational/automation, and data/statistics, so training needs to evolve to ensure the workforce can adopt them.
We will adopt a co-ordinated and scalable approach to skills development for the UK medicines manufacturing community. The Centre of Excellence will comprise a network of academic delivery partners with an unrivalled track record for delivering training for the medicines manufacturing community. We will draw on our existing infrastructure for rapid operationalisation, building onto them new approaches such as:
* Co-created, co-branded core materials for training and outreach that are readily scalable across the UK.
* Digital training approaches including cutting edge virtual reality and mixed reality to enable standardisation and consistency across our network.
* Accelerator programmes for T-level students, undergraduate placement students, graduates and CPD trainees, and apprenticeship cohort activities, supporting all career entry points.
Within two years the RESILIENCE Centre of Excellence will be self-sustaining and include over 150 affiliate member education providers and industry users, who have access to core training materials that ensure a minimum quality standard is met, enabling consistency in workforce pipeline growth across the whole UK. The UK will then continue to be a world leader in the creation and manufacturing of new medicines for decades to come.
Driven by a range of sustainability challenges such as climate change, resource depletion and an expanding population, a circular bioeconomy concept is emerging which envisages the use and re-use of sustainable resources to meet pressing societal needs. This will accelerate in the coming decades, with biorefineries and bio-based products as key cornerstones. This in turn demands the development of new technologies to replace fossil resources as the primary feedstocks; such technologies will only be adopted at suitable scale if the economics are right for all involved.
Levwave seeks to explore an innovative and highly efficient technology to produce a key sustainable chemical, levulinic acid (LA) by using aqueous streams available in the paper industry. LA has been identified as one of the top-10 bio-based chemicals. Seen as a "platform" molecule it can displace the use of fossil resources in many applications including as a green solvent, precursor for the production of advanced polymers, pharmaceuticals, additives and other commodity chemicals we all rely on. However, there is no current production in the UK.
A project team with outstanding and complementary expertise has been assembled, this contains all the necessary expertise in science, technology, process design, techno-economic and environmental impact assessment and spans the entire value chain.
At the heart of this concept is the microwave assisted catalytic transformation of aqueous biomass containing streams into LA. The biochar also be produced will be assessed for energy generation. The basic concept has been demonstrated by the University partner. There are several innovative aspects of this project; the impact of advanced catalysts on process and product will be assessed, the scale up to a continuous process will be studied and the end uses of the products will be investigated. These combined activities will provide data that will inform techno-economic and environmental assessments that will determine the commercial viability of the process from the perspective of both the paper and chemical sectors. This critical new data will be a key output of the project and allow a follow on to be structured accordingly, focussing on the critical aspects.
This project clearly responds to the ISCF call to bring together two foundation industry sectors to explore mutually beneficial technology developments that would not occur independently. Longer term the production of this key platform molecule will drive the national ambition to become leaders in low carbon, sustainable manufacturing and create regionally distributed, highly skilled manufacturing jobs.
This project brings together experts in drug development, product formulation, process design, systems modelling and manufacture to create a completely new approach to the design and manufacture of formulated drug products, which involves the integration of qualitative tools for process understanding with a range of in-silico models which describe and predict processing and product performance. It is anticipated that successful outcomes of digital design of drug formulations as envisaged in this proposal via the creation of “Design Space Explorer” will provide unparalleled improvements in reliability, quality and manufacturing processes of pharmaceutical products leading to greater trust by regulatory agencies and by society. Furthermore it is anticipated that a successful outcome to the proposed project has potential to significantly decrease the costs and times associated with the development of new medicines whilst also reducing, refining and and at times removing the need for some clinical studies in patients and healthy volunteers.
Britest Ltd is developing a methodology for assessing how the properties of a complex multi-phase formulation propagate through a process into the products on a qualitative/ semi-quantitative basis. The project is a feasibility study to ascertain whether existing tools used by Britest for chemical reaction processes can be modified to gain the required understanding from complex multi-phase formulations. Robinson Brothers Ltd are providing a case study pre-industrial process of a polymer additive to allow development and testing of the methodology and any new tools that are generated in the project. Use of the new methodology and tools will also enable companies to target elements of their process that would warrant more detailed computational modelling (e.g. through the proposed National Formulation Centre).
Awaiting Public Project Summary