Delivering Automated Just-In-Time Clinical Supply
Grand Challenge 2 at the Medicines Manufacturing Innovation Centre
Pharmaceutical industry challenges
The manufacturing of medicines for clinical trials represents a significant – but essential – investment for drug manufacturers. However, due to the inherent uncertainty in the medicines development process, the current manufacturing processes for clinical trial relies on a ‘Just-in-Case’ approach. 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 over-production to ensure a sufficient supply.
Creating a more agile and responsive supply chain will allow a transition towards manufacturing plants that can respond to ‘real’ demand and connect to subsequent supply in real-time.
![pharma-ipad pharma-ipad](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/pharma-ipad.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559211883&s=53e4b6a24d0c5fd964f21b87f00998cc 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/pharma-ipad.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559211883&s=7d82d46a4ce5523c36ae20e1d1b74fa9 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/pharma-ipad.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559211883&s=99df71596da8536ad7185df513e84ef4 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/pharma-ipad.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559211883&s=004ec84ff975292c47c446d322785ead 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/pharma-ipad.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559211883&s=4a52aaeac10145715c595496acf09aee 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/pharma-ipad.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559211883&s=aa1905dedd62564831e5d07e0392891e 960w)
![cpi-formulation-lab cpi-formulation-lab](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/cpi-formulation-lab.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559223147&s=4d8459b9b0e2990458458c33448a7c70 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/cpi-formulation-lab.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559223147&s=8adfc20d11a0bb8829bf27832b648f42 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/cpi-formulation-lab.jpg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1559223147&s=1d4010d5e3f72c91066e5dd687967d3a 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/cpi-formulation-lab.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559223147&s=c6043511a4e480108a41cc5a75e2991b 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/cpi-formulation-lab.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559223147&s=0ef367c7eba047825ad812964a977621 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/cpi-formulation-lab.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559223147&s=31a480718eb2dfa171551f855533805f 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/cpi-formulation-lab.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559223147&s=b40b26ffad44687d567226c6ecab6456 960w)
![MMIC-building MMIC-building](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MMIC-building.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1598516659&s=d5eeaf3a07c534b13f07a5e3b7f793b7 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MMIC-building.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1598516659&s=27ec4c18f297de911e831e3bf73828cb 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MMIC-building.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1598516659&s=ecb679faedf75b667f5f437391008d75 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MMIC-building.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1598516659&s=952a183d2a24cb35337af1c64fb8500d 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MMIC-building.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1598516659&s=b49b4bf0bb8e0ee16402b67606e67ef1 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/MMIC-building.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1598516659&s=7ac585d761346487fbad5b28e0836045 960w)
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.
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.
Enabling innovation
Grand Challenge 2 will facilitate innovation through the following areas:
Integrated automation
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 over-production, responding faster to changes in trial strategy. Achieved through automation equipment and software development.
Automated technology
Generating real-time quality data throughout the manufacturing process and produce drugs in quantities that meet near-term market demand. Ultimately, the project aims to develop responsive technology that can fulfill individual patient orders on demand.
Modular design
Allowing multiple drug products to be packed into bottles on the same packing line without cross-contamination. Bottles are packed and labeled in one process and stored with a customised bar code that enables rapid labeling 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 the 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 create efficiencies and reduce cost in pharmaceutical supply chains.
Ongoing interactions with regulatory bodies will also ensure the PACE design is aligned with regulatory expectations.
![Neil Sheddan Neil Sheddan](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/neil-sheddan.jpg?w=480&h=480&auto=compress%2Cformat&fit=crop&dm=1610377813&s=5ec42a9203b221aacc572048a7815985)
Neil Sheddan
Business Development Director
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.
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 innovative platform for drug manufacture.