Complex biologics and next-generation cell and gene therapies demand precision handling to maintain stability and promote optimised and patient centric clinical trials. As a result, biopharmaceutical organisations must adapt traditional supply chains to ensure that appropriate environmental conditions are maintained from production through to patient assignment. Get it wrong and the consequences can be catastrophic. Physical degradation, chemical instability and microbiological contamination can occur; compromising patient safety and commercial performance in one fell swoop.
While environmental factors, including light and humidity, play a key role in maintaining the stability of some investigational medicinal products, ‘the most important environmental parameter having significant potential to impact the quality of pharmaceutical products is temperature’.
Maintaining strict temperature ranges for biopharmaceutical products through all handling, distribution, and storage steps in the supply chain isn’t a straightforward task. Multiple risk factors exist that can cause deviations and threaten drug stability. Considering the high cost of bringing new drugs to market, effectively addressing these risk factors isn’t just a matter of patient safety, but an opportunity to maximise return on investment potential.
The trouble is when a fragmented approach to temperature management is employed, an approach that relies heavily on human intervention, error and inefficiency ensue. To secure a stable environment, a holistic, connected, and technology-enabled temperature surveillance and management strategy is required. One that is fuelled by accurate and complete data, and bolstered by expertise, to deliver end-to-end visibility and control, without creating additional workload for any one stakeholder group.
Understanding Temperature Excursions
When temperature-sensitive supplies leave the audited facilities of sponsors or CDMOs, and start the journey to sites and patients, the likelihood of temperature excursions increases, while detectability plummets. When drugs are in transit, it can be more difficult for sponsors to know if an excursion has occurred and whether it has been appropriately reported in line with defined processes. This reduced visibility and control extends to storage at clinical sites and, with the shift towards decentralised clinical trial models, within patients’ homes.
In an ideal world, if excursions occur, they should be reported in line with defined processes and appropriate action taken based on the outcome. The worst-case scenario with this is that drugs are rejected, potentially impacting the clinical site’s ability to dose the patient, resulting in perhaps losing the patient from the trial – increasing product resupply and recruitment costs, while delaying timelines. Indeed, temperature excursions are estimated to cost the pharmaceutical industry an average of $15 billion each year. The other side of the risk associated with excursions is that, if they go unreported, the compromised drug remains available and patient safety as well as corporate reputation, hangs in the balance.
