SUPPLY CHAIN MANAGEMENT
IRT, sponsors can obtain a holistic view of the supply chain from production through patient enrolment.
This empowers sponsors to anticipate trends, adjust strategies dynamically and optimise inventory to reduce waste and avoid costly delays, while ensuring patients receive timely supply of study drugs. A combination of expertise and powerful forecasting tools can deliver greater efficiency, mitigate risk and support patient-centric, on-time, on-budget trial execution.
Similarly, because IMPs often require customised secondary packaging for blinding, randomisation and multicountry labelling purposes, operations can become highly bespoke. This serves to reduce economies of scale and magnify the impact of any forecasting error, as unused kits cannot easily be repurposed for use elsewhere.
JIT strategies
One way to overcome these challenges – along with a lack of access to longterm stability data and shelf-life uncertainty- is to adopt just-in-time( JIT) strategies that help to preserve high value, low volume drug products. JIT can range from a partial late-stage customisation, where an auxiliary label is added at the time of dispatch, to full late-stage customisation( via secondary production), where drug supply is maintained in its primary pack, such as naked vials, ampoules and syringes, until there is an actual site or patient need.
JIT labelling( JTL) is ideal for quick additions to an already clinically labelled kit and is typically best suited to small molecule operations involving wallets and bottles. Similarly, JIT manufacturing( JTM) can help create optimised and adaptive supply chains that promote enhanced product viability and significantly reduced product waste.
With a JTM model, the process of label printing and kit assembly for full late-stage customisation is initiated by drug order forms. This brings several key advantages for sponsors looking to optimise use of high value, low volume clinical supplies, while maintaining viability.
Firstly, this approach provides sponsors with the ability to utilise single-panel, country-specific labels. This has been proven to decrease study start-up timelines by up to 50 %, helping sponsors meet key study milestones faster and more cost-effectively.
Secondly, it empowers sponsors to print study-specific labels with the most current label variables, such as the most recently approved retest date. This helps to reduce waste and improve bigger picture efficiency.
Finally, by delaying labelling and kit assembly until a patient need arises, supplies remain usable for any country or study, which drastically reduces the risk of costly stock outs and negative impact to both patients and trial performance.
Maintaining stability
IMPs often present significant stability challenges due to their complex molecular structures and sensitivity to environmental factors, including temperature, humidity and light. These compounds can be chemically reactive, hygroscopic or prone to degradation under stress conditions, making it difficult to generate long-term stability data early in development.
This in turn creates uncertainty around shelf life and storage conditions. As a result sponsors must often rely on accelerated or ongoing stability studies, while trials are active, leading to frequent packaging and labelling updates and reinforcing the need for a lean and adaptive production approach.
However, sensitivity to environmental factors also requires precise handling from production line to patient. And while environmental factors, including light and humidity, play a key role in maintaining the stability of some IMPs,“ the most important environmental parameter having significant potential to impact the quality of pharmaceutical products is temperature”. 2
Maintaining strict temperature control across all temperature ranges, through all handling, distribution and storage steps in the supply chain, is essential to maintain stability. However, multiple risk factors can cause deviations and compromise a drug’ s acceptability for use.
For instance, when temperaturesensitive supplies leave the audited facilities of sponsors or CDMOs and start the journey to sites and
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