Delivering Automated Just-In-Time Clinical Supply

Grand Challenge 2 at the Medicines Manufacturing Innovation Centre

The industry challenge

Manufacturing medicines for clinical trials is a significant – but essential – investment for drug manufacturers. Yet, due to inherent uncertainty in the medicines development process, pharma companies currently rely on a ‘just-in-case’ approach, which leads to over-production. This leads to wasted time and resources, as well as causing delays in getting drugs to patients.

Creating a more agile and responsive supply chain is one of the key challenges for the pharmaceutical industry today. It will facilitate the transition towards manufacturing plants that can respond to ‘real’ demand and connect to subsequent supply in real-time.

‘Just-in-time’ manufacturing makes these goals possible.

‘Just-in-time’ manufacturing

An alternative to current large-batch methods, just-in-time (JIT) manufacturing enables companies to produce drugs with far shorter lead times and at more exact quantities to meet specific levels of demand. The model we have developed relies on an innovative, automated supply chain platform to enable late-stage customisation of trial stock and single-patient ordering during the clinical trials process.

Ultimately, JIT manufacturing allows more flexibility in clinical trial medicines production at a lower environmental cost, resulting in a cheaper supply of clinical trial medicines to patients. It can also reduce current timescales from weeks to days, getting vital medicines to patients more quickly.

Our just-in-time manufacturing solution

At the Medicines Manufacturing Innovation Centre, we have developed the PACE (Pharmacy Automation for Clinical Efficiency) platform. It’s a digitally enabled automated line, interfacing novel hardware with innovative software, which enables quality control teams to monitor and release batches.

The platform is available now for clients looking to test the capabilities of this exciting technology.

Our team can demonstrate how the platform works and create a kit tailored to your specific needs, offering some of the following benefits:

QP Dashboard

Real-time electronic QP certification and release

Cross-site QP Assurance through smart data management

Create on-demand capability with predictive scheduling to manage material and data

Modular Automation Platform

Access a secure data chain with single bottle tracking on point of entry

Cost-effective single-patient labelling

Packaging multiple products on same line — tablets and capsules

Automated bottle filling

Adaptable to other formulations

Just-In-Time Labelling

Real-time parsing, printing and digital verification inspection of variable label data

Minimal operator interaction required

Automated print, inspection, reject and reprint capabilities

Connection to multiple label print and applicator heads

Label master template design platform.

PACE explained

PACE brings the production, packaging and labelling of multiple drugs under one roof without cross-contamination. It all takes place on a single line in a GMP environment with real-time quality checks, resulting in lower risk and cost while maximising speed to patient.

PACE’s modular approach enables the fast, flexible filling, labelling and release of low-volume, high-value drug products. Capable of processing multiple contained APIs in the same cleanroom at the same time in a demand-driven JIT process, it eliminates the need for deliberate over-production. This increases process efficiency and decreases waste, offering a smaller carbon footprint than traditional packaging lines.

Alongside PACE, we’ve developed a real-time digital release dashboard for Qualified People (QPs). It will automatically gather the data necessary for drug approval in real-time, pulling critical GMP and registration data from both MMIC and sponsor systems so medicines can be QP-certified while the product is being packed. This will enable the rapid release of drugs from a warehouse and onwards for distribution at study sites.

Benefits of this technology

Integrated automation

Enabling a clinical supply chain that can rapidly and responsively process material on an actual or short-term demand-driven basis. Accelerate the availability of trial supplies, reducing over-production and responding faster to changes in trial strategy.

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 delivers responsive technology that can fulfil 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 labelled in one process and stored with a customised bar code that enables rapid labelling before distribution to individual patients.

Digitisation of the platform

Enabling 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.

Collaborate with CPI

At the Medicines Manufacturing Innovation Centre, we employ a collaborative operational model. This 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.

We’re delighted to have welcomed several new partners to the collaboration, including Siemens, Applied Materials, and SewTech, who bring a diversity of expertise and the strength of their automation and digital skills to the project.

We are actively seeking new partners to maximise the impact of this innovative platform for drug manufacture.

Find out more about our just-in-time medicines manufacturing capabilities:

For more information

Jim McGuire

Grand Challenge Lead

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Innovation insights

Accelerating drug production with “just-in-time” manufacturing