Written by: Paul Knight, Managing Director of CME Automation Systems
One of the biggest challenges facing the life sciences industry is how to implement automated ‘just-in-time’ clinical supply chains that will increase speed, flexibility, and efficiency in clinical trial drugs manufacture.
It’s clear that these are exciting times for the clinical trials sector. As demand grows for innovative treatments, especially in areas such as gene therapies or personalised medicines, so too does the value of the global market – which could be worth potentially as much as $100 billion by 2030, according to one forecast.
With this opportunity, though, comes a sizeable challenge: scalability. Getting new drugs into worldwide circulation is a painstaking process, to ensure regulatory compliance and – most importantly – patient protection. Efforts are being made to minimise any delays in this process. For example, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to streamline approvals. Cited as the biggest overhaul in UK clinical trials regulation in over 20 years, the aim is to make it faster and easier to run trials.
This is great – but without investment, innovation, and collaboration elsewhere in the supply chain, the benefits will be moot. Regulatory bottlenecks are compounded by the logistical challenges involved in small-batch production. As therapies become ever more tailored, there will be a lot of drugs competing for production lines, packaging infrastructure and cleanroom space.
The key question then becomes how to deliver the growing number of clinical trials, in the first place. Finding a solution to this will help overcome long lead times for supplying medicines, avoid wastage, and make it easier to respond to patient demand. Any student of manufacturing will know that the hardest bridge for clinical trials to cross is moving from a ‘just in case’ (JIC) model to a ‘just in time’ (JIT) process.
It’s no surprise that, today, pharmaceutical manufacturers are planning with caution and, therefore, holding a larger inventory of stock. It can be difficult to predict patient demand with any degree of accuracy, while delays in recruitment to trials are commonplace. Equally, though, there’s a tricky balancing act in clinical trials manufacture between consignment sizes volumes and cleanroom conditions. Changeovers can be complex and costly, and a JIT model isn’t practicable based on existing manufacturing techniques. The grail in this situation is a more agile and responsive supply chain, geared towards developing a transformative shift that makes JIT manufacturing a reality.
Such is the importance of this quest that it has been officially adopted as one of two ‘Grand Challenges’ by the UK-based Centre for Process Innovation (CPI). Grand Challenge 2 (“Delivering Automated Just-In-Time Clinical Supply”) is a multi-partner collaboration, whose ambition is “to develop a supply chain of the future which can drastically reduce current timescales of over 300 days to 30 days.”
As implied by the title of Grand Challenge 2, the project’s success will lie in automation. Just as automated technology enables the pharmaceutical industry to deliver medicines both at speed and at scale, the aim here is to achieve the same responsiveness for smaller trial shipments.
There are many factors to consider – otherwise such a model would already exist. This is why the CPI has invited several organisations from across the clinical trials supply chain, including CME Automation Systems, to collaborate on developing a viable solution, which is being tested at the Medical Manufacturing Innovation Centre (MMIC) in Strathclyde.
CME’s key role in the project has been to build a faster, more agile supply chain while still maintaining cleanroom conditions. Without a sterile manufacturing environment, the efficacy of any trial product may be compromised – or at the very least, data on its performance will be undermined.
Against this, the trend is towards more, not less, diversity of packed products, due to the rise in late-stage customisation and single-patient ordering. With unlimited space, it would of course be possible to build giant cleanrooms. However, for financial as well as environmental reasons, this is hardly viable. The goal is that multiple products can be packed in the same small footprint as any mass-market, JIT medicine.
Accordingly, the solution we have developed, and which is currently deployed at MMIC utilises a multi-product modular automation line, known as PACE. The system is designed to deliver the production, packaging and labelling of multiple drugs in the same facility without cross-contamination. In other words, to enable faster changeovers and late-stage customisation while maintaining tight clinical protection.
The PACE system fills bottles with OSD in either tablet or capsule format, or fill finish into vials, without the risk of cross contamination, whilst maintaining complete traceability throughout the system.
It all takes place on a single line in a Good Manufacturing Practice (GMP) environment with real-time quality checks, resulting in less waste, risk, and cost while maximising speed to patient.
A key innovation is the patented design of the filling station. This enables a single line to incorporate a series of subsequent humidity and temperature-controlled drug filling stations, each configured as a fully functioning independent unit. They are designed to allow quick changeover of pharma product types, for example to dispense tablets or capsules of differing drug types and strengths.
The filling stations sit at the centre of a full line solution, comprising handling, filling, sealing, weighing, marking, labelling, and packing. It is digitally enabled to provide real-time connectivity for greater accuracy and speed in verification, via QP dashboard, and ongoing data insight using digital twin technology. Rigorous checking processes along the line reject any bottle that fails, and these are logged so that that specific order can be fulfilled at the next available opportunity.
With PACE now in operation at MMIC, we are seeing how the use of automation, carefully controlled in cleanroom conditions, will enable a clinical supply chain that can rapidly and responsively process material on a truly demand-driven basis, both actual and short-term. Benefits include the acceleration of trial supply availability, reduced need for over-production, and improved responsiveness to changes in trial strategy.
Ultimately, the shift towards a JIT manufacturing model for clinical trials medicines will result in a faster, more agile supply to patients. By balancing speed, flexibility and efficiency, this transformative model will help the industry to realise the huge growth potential in the market without compromising on clinical protection or resorting to greater cleanroom footprints.
Progress to date has reinforced the viability of the system, while ongoing interactions with regulatory bodies are ensuring alignment with their expectations. For the clinical trials industry, these capabilities open the door for more trials per year, as well as more diverse trials – for example, by trialling multiple doses and strengths simultaneously. A future where new products can be delivered faster, more flexibly and cheaper than before is now within sight.