Transforming tablet production
Continuous direct compression at the Medicines Manufacturing Innovation Centre
Summary
Ageing populations, rising healthcare costs, drug development costs, and the need to make manufacturing processes more sustainable are just some of the challenges facing the pharmaceutical industry today.
The Medicines Manufacturing Innovation Centre, a collaboration between CPI, University of Strathclyde, UKRI, Scottish Enterprise, AstraZeneca and GSK, has pioneered a new, faster, more efficient and sustainable tablet production process to ultimately benefit those most deserving – patients.
A Grand Challenge for Pharma
Medicines manufacturing has not changed significantly in over 40 years. At the same time, the rising cost of global healthcare systems means that the processes that deliver medicines to them need a new approach.
Current medicines manufacturing involves inefficient traditional large-batch methods that are resource and time-intensive. Meanwhile, new medicines are trending towards more complex, stratified products that need to be produced in lower volumes.
The challenge for the pharmaceutical industry is to achieve greater efficiency and flexibility. The solution lies in Continuous Direct Compression (CDC).
Continuous direct compression
Continuous direct compression (CDC) of oral solid dosage medicine is a novel manufacturing method that aims to eliminate some of the cost and complexity of old traditional batch processes. It enables drugs to be developed and scaled up using much lower quantities of expensive and complex ingredients, facilitating rapid production of formulations at a range of scales.
Shorter production runs enable pharma companies to respond more effectively to differing patient needs while simultaneously reducing the development burden and costs.
The CDC physical line we have developed is also digitally twinned. This means that the manufacturing process is digitally simulated to test its performance and efficiency. Using real-world data, scientists can better understand and optimise the process design.
This twofold benefit of working with smaller batches and of design optimisation allows the pharmaceutical industry to make better-informed formulation choices and produce tablets in an energy and resource-efficient way.
Our CDC offer
At the Medicines Manufacturing Innovation Centre, we are now offering a service to advance your CDC process development activities through the utilisation of our digital twin and physical access to our continuous direct compression line.
The line is fully modular and vendor agnostic, enabling flexibility to your tabletting needs. Through this — CPI can fully support your CDC journey.
As a client you can benefit from various offer levels:
Physical CDC line
Work on your development project on a one-to-one basis, with full access to the process support team in strict confidentiality.
Equipment capabilities:
5 Loss in Weight Feeders of various size and screw capabilities (0.5 – 10L) to provide possibilities for optimum feeding into the CDC line, depending on the product.
<50kg/hr throughput
Rated to occupational exposure band 4 (OEL 4; OEB <1µg/m3) to handle potent material
2 distinct blending options (continuous and mini-blend) to mix powdered raw materials into uniform blends, with various weir options
NIR PAT capable, with spider wheel post blend or within the tablet feed frame
Korsch X3 Tablet press with in-line PharmaCheck analyser (weight, thickness, hardness), capable of producing up to 150,000 tablets per hour
PharmaMV software for process control
SIMATIC SIPAT data capture interface
Digital Twin Consultancy
Speed up tablet development through our consultancy service, to predict both the batch and continuous compression processes, in silico.
Digitally predict process parameters prior to committing raw materials to experiments, contributing to sustainability targets
Harness the team’s expertise using Siemens gPROMS and Applied Materials PharmaMV modelling tools
Investigate the system’s dynamics over domains of user-selected input variables to define the design space
Retrain the Digital model with client material
Process Development
Advance CDC process development and scale-up through our innovative digital twin and collaborative technical support across multidisciplinary technology teams
Predict, in silico, the processing success of APIs and excipients, working with our dedicated modelling team.
Support formulation design, equipment selection and enhance understanding of the design space to develop the control strategy
Benefits of CDC
60 – 70% reduction in facility size
30 – 50% reduction in manufacturing costs
69% reduction in energy consumption
Putting CDC into action
Uptake of CDC in the industry has been relatively slow, with just 12 products known to be commercially available as of 2024. At the Medicines Manufacturing Innovation Centre, we have brought together industry, academia, healthcare providers and regulators to make this important new technology commercially viable.
The team created a world-class demonstrator in a good manufacturing practice (GMP) environment to prove CDC principles at commercial scale, helping the industry to transition to continuous and minibatch manufacturing. The digital twin program takes the transition support even further.
Together, they drive efficiency in pharmaceutical product development, as well as allowing for tailoring of medicines for specific patient groups.
This will support the industry to shift from traditional large batch manufacturing approaches – which are based on forecast demand so require large amounts of inventory – to continuous and mini-blend manufacturing.
The digital CDC platform will deliver:
Sustainability
Reduced starting materials, less waste and energy, and a smaller footprint, which results in a lower environmental impact.
Commercial advantage
Reduced development and manufacturing times gets products to market faster.
Product improvements
Increase in yield and consistency.
Reduced running costs
Less material waste.
Real-time monitoring
Enables early detection and prediction.
Faster processing time
Reduced from weeks to days.
Faster modelling time
Reduced from hours to minutes.
Regulatory compliance
Consistent manufacture of product that can be verified using real-time data.
Collaborating with CPI
At the Medicines Manufacturing Innovation Centre, we employ a collaborative operational model, which enables partners to join through a combination of direct funding and benefit-in-kind contributions towards resources or technology.
Alongside our founding partners AstraZeneca and GSK, we’re delighted to have welcomed several new partners to the collaboration, including Pfizer, Siemens, Gericke, Applied Materials and DFE Pharma, who together bring a wide range of expertise to the project:
We are actively seeking new partners to maximise the impact of this innovative platform for drug manufacture, over a series of new projects
- Advancement / comparison in PAT technologies as a driver towards PAT robustness for continuous manufacturing
- Delivery of co-developed CDC product development and regulatory best practice document / white paper
- Sustainable tablet manufacture using Advance Process Control (and self-optimisation) as a control strategy
- Actively bridge the core gap in skills and knowledge to provide the capability to develop new assets on this technology and demystify continuous manufacturing
If you would like to get involved, or wish to find out more about our CDC capabilities, reach out today.
For more information
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