Rethinking Just in Time Manufacturing for Clinical Trials
Just in Time Manufacturing (JTM) is still a relatively new production approach within drug development. Yet as the industry moves towards more flexible and patient centric models, many sponsors are starting to rethink its place within their clinical supply strategies.
Almac Adapt™, Almac Clinical Services’ JTM solution, enables late-stage customisation of clinical kits once demand signals are received, allowing supply to be aligned more closely with real-world patient and site needs. It’s a proven tool for studies involving personalised therapies, uncertain enrolment patterns or constrained drug supply – helping to boost efficiency, reduce risk, control cost, and centre patients in the clinical trial operation.
But before you embark on your demand-led manufacturing journey, there are several factors to consider (and myths to dispel).
Read on to discover more…
Cost considerations
JTM is sometimes viewed as a higher-cost option due to the smaller, more frequent operations involved. From a traditional manufacturing perspective, this can appear to limit economies of scale.
However, when assessed across the full clinical supply lifecycle, JTM can help offset initial costs by reducing overproduction, minimising excess overage and limiting returns, destruction and accountability activity.
In many cases, these efficiencies contribute to a more balanced overall cost profile, particularly for studies with variable or uncertain demand.
Applicability across study sizes
JTM is well suited to smaller or early-phase studies, especially those involving niche indications or targeted patient populations where forecasting demand can be challenging.
However, its value extends beyond these settings. In larger trials, JTM can play a critical role during early enrolment, when recruitment rates and global demand are still evolving, helping sponsors manage uncertainty and protect investigational medicinal product (IMP). As enrolment stabilises, sponsors can choose to transition to batch manufacturing for later treatment cycles, creating a flexible, hybrid supply model that evolves alongside the study.
Relevance across therapeutic areas
While JTM is often associated with rare disease and cell and gene therapies, its benefits extend beyond any single therapeutic area. The ability to respond quickly to changing demand, while preserving drug product is relevant to a wide range of studies.
Trials in oncology, immunotherapy and investigator-initiated research, for example, often face enrolment variability or limited drug availability – conditions where an on-demand approach can provide meaningful support.
Compatibility with IRT systems
JTM can be successfully integrated into studies that use interactive response technology (IRT), as well as those managed through manual processes.
Supplies manufactured through a JTM model are released into IRT systems using the same standard metadata as batch-produced supplies. This allows sponsors to maintain familiar workflows, while benefiting from a pull-through supply strategy that supports waste reduction and inventory optimisation.
Use across different IMP types
While JTM is often associated with biologics and advanced therapies, it is not limited to them. It can be applied across a range of IMP formats, including solid oral dose medications.
When demand cannot be predicted with confidence, an on-demand approach offers flexibility regardless of compound type, helping sponsors maintain continuity of supply while avoiding unnecessary production runs or re-work.
Interested in exploring how JTM can support your clinical trial? Speak to us about Almac Adapt™.
