Delivering Automated Just-In-Time Clinical Supply
Grand Challenge 2 at the Medicines Manufacturing Innovation Centre
Pharmaceutical industry challenges
Due to the inherent uncertainty in the medicines development process, the current manufacturing processes for clinical trial stock can be wasteful. Long lead times for medicines stock supply, difficulty in accurately predicting patient demand and delayed recruitment to trials are just some of the reasons that lead to large quantities of waste in trials.
These inefficiencies lead to ‘Just-In-Case’ manufacturing, meaning pharmaceutical companies over-manufacture and stockpile medicines to ensure a steady supply. Due to this overproduction a significant quantity of the stocks that are made and delivered to clinical trial sites ultimately go to waste. Transitioning away from a wasteful, ‘Just-In-Case’, manufacturing approach requires manufacturing plants that can respond to ‘real’ demand and connect to subsequent supply in real-time. Ideally this technology would also have a smaller footprint that can be quickly set up and adapted to evolving drug demand. Not only will this approach reduce the costs associated with carrying out clinical trials by reducing waste) but it will also facilitate the rapid delivery of small batches of medicines and enable rapid changes in trial strategy to be accommodated; leading to faster and more adaptive trials.
Transforming pharmaceutical supply chains with speed and efficiency
Pharmaceutical companies in search of step-change solutions for clinical trial stock management will benefit from involvement in this technology; which is applying automation and digital tools to large and small GMP trials. The collaborative approach will accelerate packing processes and deliver effective manufacturing solutions for our partners and the industry as a whole; enabling late stage customisation of trial stock and single patient ordering. This technology is wrapped up in a small footprint, multi-product modular automation line.
Collaborators will benefit from the IP generated, which is designed to be swiftly integrated into commercial organisations on completion of the project.
Ultimately, the Just-In-Time project will enable more flexibility in clinical trial medicines production at a lower environmental cost, resulting in a faster and cheaper supply of clinical trial medicines to patients.
A Collaborative approach
The Medicines Manufacturing Innovation Centre is a collaboration between CPI, the University of Strathclyde and founding industry partners, GSK and AstraZeneca with funding provided by Scottish Enterprise and UK Research and Innovation. The Centre allows industry, academia, healthcare providers and regulators to work together pre-competitively to solve industry challenges and de-risk new technologies, that are simply too large for one company to address.
The partnership model aims to revolutionise medicines manufacturing enabling a clear pathway for the adoption of innovation within the pharmaceutical industry. It will do this by delivering large strategic projects, known as Grand Challenges, which overcome industrial hurdles limiting pharmaceutical development.
Grand Challenge 2 - Delivering Automated Just-In-Time Clinical Supply
Developing the supply chain of the future. Increasing speed, flexibility and efficiency in clinical trial drugs manufacture.
The collaboration will deliver ‘Just in Time’ supply of drugs to patients in clinical trials through the development of an innovative, automated supply chain platform.
The ambition is to develop a supply chain of the future which can drastically reduce current timescales of over 300 days to 30 days.
The PACE (Pharmacy Automation for Clinical Efficiency) platform is a digitally-enabled automated line interfacing novel hardware with innovative software which enables quality (specifically QPs) to monitor and release batches. A key innovation in PACE enables it to deliver the production, packaging and labelling of multiple drugs in the same facility without cross-contamination. It all takes place on a single line in a GMP environment with real-time quality checks, resulting in less waste, risk and cost while maximising speed to patient.
Reduced lead time
- From 30 days to one day for pack/label/release – enabling much faster movement in clinical trials
- Changes in trial design can be easily accommodated
- Clinical trials waste around £5 – 10 million / year. Enabling flexibility and shorter timescales to reduce the need for stockpiling
- Carbon efficiencies by providing faster distribution to patients, lower levels of production and storage space, helping companies take big steps towards net zero requirement
- Qualified Persons (QPs) can focus on critical tasks
Grand Challenge 2 will facilitate innovation through the following areas:
Enabling a clinical supply chain that can rapidly and responsively process material on an “actual or short-term” demand driven basis; Accelerating the availability of trial supplies, reducing materials waste, responding faster to changes in trial strategy. Achieved through automation equipment and software development.
Generating real-time quality data throughout the manufacturing process and produce drugs at quantities that meet near-term market demand. Ultimately, the project aims to develop responsive technology that can fulfil individual patient orders on demand.
Allowing multiple drug products to be packed into bottles on the same packing line without cross-contamination. Packed bottles are sealed and stored with a customised bar code that enables rapid labelling before distribution to individual patients.
Secondly, a real-time digital QP release dashboard is being developed that will automatically gather the data necessary for drug approval In real time, this dashboard will automatically pull critical GMP and registration data from both MMIC and sponsor systems in order to enable Just in Time QP certification at the same time as the product is packed. This will enable rapid release of drugs from a warehouse and onwards for distribution at study sites.
Digitisation of the platform
The innovative use of digitisation throughout the platform will enable the factory-in-a-box approach required for a more agile and responsive supply chain of the future. There is the potential to connect the manufacturing data train (from PACE) to Internet of Things (IoT) devices, for example ‘smart’ labels could further cut excess waste and cost in pharmaceutical supply chains.
Ongoing interactions with regulatory bodies will also ensure the PACE design is aligned with regulatory expectations.
Joining the collaboration
The collaboration has welcomed new partners: Siemens, PS Enterprises, Perceptive Engineering and Applied Materials, who bring diversity of expertise and the strength of their automation and digital skills to the project.
We are actively seeking new partners, both SMEs and large corporations, to maximise the impact of this innovation platform for drug manufacture.
Pharmaceutical companies can gain access to this step change technology in a pre-competitive environment – making manufacturing and supply chains more productive and responsive, leading to improved patient experiences. Whilst, technology companies can showcase their capabilities by becoming part of this unique collaboration model.