About
CMAC’s Future Continuous Manufacturing and Advanced Crystallisation Research Hub (2017–2024) was a landmark EPSRC-funded initiative that brought together leading UK universities and industry partners to address critical challenges in high-value pharmaceutical manufacturing. The Hub fostered a collaborative, open innovation ecosystem focused on advancing continuous processing and enabling the future of personalised medicines.
As a national centre of excellence, the Hub supported research across Technology Readiness Levels (TRL) 2–5, forming a cornerstone of CMAC’s broader research strategy. Its work has laid the foundation for transformative advances in how medicines are developed, manufactured, and delivered.
EPSRC grant reference: EP/P006965/1
“This programme has been a tremendous success in delivering against CMAC’s research strategy.
Our outputs have included novel digital first approaches for continuous process design and mechanistic insights to particle engineering processes.
We’ve also developed digital workflows that establish knowledge models describing process development steps, and a framework to enable the shift from Quality by Design (QbD) to Quality by Digital Design (QbDD). ”
Our research
The UK’s investment in the CMAC Hub laid the foundation for a growing portfolio of aligned research projects. Building on this momentum, CMAC’s 2021–2026 strategy expanded the Hub’s impact by focusing on industry-driven manufacturing challenges. By strengthening our network of projects and facilities, we identified key priority areas for further innovation.
This collaborative approach led to the successful launch of over 43 funded projects, securing more than £56 million in research investment to advance the future of pharmaceutical manufacturing.
Driving innovation through digital design
CMAC’s Quality by Digital Design (QbDD) framework has advanced the Food and Drug Administration’s (FDA) Quality by Design (QbD) approach by integrating modelling and digital tools to drive sustainable, efficient, and innovative pharmaceutical manufacturing. Applied to three active pharmaceutical ingredient (API) processes, QbDD achieved up to 65% material savings and reduced experimental workload by 28% through digital optimisation.
Our 2023 study on mefenamic acid production demonstrated a digital-first design strategy, enhancing process robustness and flexibility, and accelerated development timelines.
Enabling predictive, data-driven manufacturing
The Crystallisation Classification System (CCS) User Requirements Specification (URS), co-developed with our Tier 1 partners defines the core capabilities of CMAC’s predictive digital framework for Chemistry, Manufacturing, and Controls (CMC) development. By integrating models, experimental data, and digital workflows, the CCS accelerates medicine development while enhancing decision-making.
The URS outlines the system’s value proposition, technical deliverables, prediction accuracy, and data requirements, serving as a strategic guide for ongoing and future research both within and beyond CMAC.
The Crystallisation Screening DataFactory (CSDF) is an autonomous robotic platform that optimises crystallisation using machine learning, collaborative robotics, and automated systems. It ensures FAIR data practices and continues to evolve through new research funding.
Flexible, integrated manufacturing platforms
Our Drug Substance MicroFactory features a flexible MSMPR system with real-time PAT control, enabling both batch and continuous operations. Equipped with advanced filtration, washing, and drying units including the AWL CFD25 carousel filter and PAT-enabled real-time control of Critical Quality Attributes (CQAs), it has demonstrated QbDD principles across four API processes.
Our filament-free 3D printer (UK patent pending) enables pharmaceutical additive manufacturing of previously unprintable formulations, offering new pathways for personalised medicine production.
Advanced Characterisation and Digital Twins
Through partnerships with national facilities like Diamond Light Source and the Henry Royce Institute, we have advanced characterisation techniques across molecular to particle scales. Our Digital Twin framework connects data, models, and knowledge across drug substance and product manufacturing, enabling predictive control and optimisation.
With over 126 digital assets developed and 24 technologies translated to industry since 2022, our digital toolbox is powering the next generation of pharmaceutical manufacturing.
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Particle, Fluid and Impurity Transport During Filtration, Washing and Drying
Nucleation Absolute Rate Theory: Developed a new theory for homogeneous nucleation, linking supersaturation, solubility, and temperature to real-time process modelling
Mechanistic modelling and process understanding
The Hub developed mechanistic models for key processes such as spherical agglomeration, OSD dispersion, and dissolution, supported by novel techniques like optical coherence tomography (OCT). These models are being integrated into digital platforms to support robust, scalable process design.
Rethinking pharmaceutical supply chains
Our supply chain research explored how advanced manufacturing can reshape pharmaceutical networks. Using multidisciplinary methods, the team identified opportunities for reconfiguration aligned with QbDD workflows, supporting more resilient and responsive supply systems.
Building the future of medicines manufacturing
At CMAC, our work in Quality by Digital Design (QbDD) is shaping the future of pharmaceutical manufacturing. We've established a robust framework through impactful publications, strategic industry partnerships, and contributions to regulatory innovation via initiatives like the Digital CMC CERSI, and training hubs such as CEDAR, our Centre for Doctoral Training, and MediForge, a new EPSRC funded research programme.
Our DataFactories, including the Crystallisation Screening DataFactory (CSDF), are delivering high-quality datasets that power the co-developed Crystallisation Classification System (CCS)—supporting sustainable, resilient manufacturing aligned with Industry 5.0 principles.
Through cutting-edge research in Digital Twins, we've developed 126 digital assets and successfully translated 24 technologies into industrial applications since 2022.
Our flexible MicroFactory platforms are advancing process technology, process analytical technology (PAT), and digital integration. Innovations such as our patented filament-free printer and pilot CCID demonstrators are actively shaping the next generation of manufacturing systems.
Expected benefits our research outputs:
Accelerated development of product and optimised manufacturing processes
Closer integration of Drug Substance and Drug Product manufacture
Increased use of Digital Twins to drive MicroFactory design, operation and control
Advanced characterisation capability advanced across length scales from the molecule to the particle
Enhanced of Drug Product Performance model capability
Feasibility studies
The CMAC Hub conducted four strategic feasibility studies designed to broaden engagement with the wider research and industry community. These studies explored orthogonal approaches to longstanding challenges, uncovering fresh perspectives and paving the way for new collaborative opportunities.
The outcomes included several peer-reviewed publications and the development of at least one collaborative grant proposal, demonstrating the value of early-stage exploration in driving innovation.
National Hub
As a UK National Centre, CMAC has aligned closely with key policies, supporting initiatives like the Medicines Manufacturing Industry Partnership (MMIP) as part of ABPI’s manufacturing vision, Made Smarter, and FDA’s global strategy. Our leadership in advanced manufacturing, digital tools, and autonomous lab systems has influenced regulatory frameworks, securing funding for projects like the Digital CMC CERSI to collaborate with MHRA and FDA on digital CMC standards.
Skills development is central to CMAC’s mission, with our doctoral and early career researcher training producing highly skilled talent recognised by industry. The Hub’s success has led to significant new investments, including the launch of the CEDAR CDT in 2024.
Through engagement activities like Open Days, international conferences, and our 2024 Showcase event in Glasgow, CMAC continues to connect with industry, policymakers, and regulators to drive the UK’s leadership in medicines manufacturing, digital transformation, and sustainability.
