Niall Balfour, Chief Executive Officer at Tower Cold Chain, explores the role of small box, temperature-controlled containers in the clinical trial market.
The global clinical trials market is rapidly expanding, with recent projections estimating a value of nearly $100 billion by 2030, according to Fortune Business Insights. This growth is spurred by advancements in medical research and development, alongside evolving regulatory landscapes aimed at expediting trial approvals, like those introduced by the MHRA.
In this dynamic environment, the transportation of clinical trial materials – ranging from biological samples to personalised drugs – demands meticulous attention to ensure they maintain their integrity and efficacy until the point of use. Given the high value, perishable nature, and vulnerability of these products to temperature fluctuations and microbial contamination, maintaining a stable and secure environment during transit is paramount.
The implementation of small box, temperature-controlled solutions has emerged as a key strategy in addressing this logistics challenge. Investing in packaging solutions specifically tailored for smaller shipments, with an optimal packaging-to-payload ratio, is vital for navigating the complexities of modern clinical trial supply chains.
Complexities in Clinical Trial Shipping
As clinical trials expand globally, maintaining temperature control during transportation over vast distances and diverse climates poses significant challenges. This issue is particularly pronounced in remote locations where local infrastructure and road conditions may be far from ideal – for example, if access to electricity is unreliable or non-existent. The safe delivery of clinical trials in such areas requires robust cold chain solutions that can maintain internal temperatures and prevent damage during transit yet remain portable enough to ensure delivery anywhere in the world. Therefore, containers must strike the optimal balance between high performance, durability, and optimised size and weight.
And yet, pharmaceutical manufacturers face the additional challenge of ensuring all container systems pass rigorous qualification stages to meet regulatory requirements, industry standards, and performance expectations critical for the safety and quality of drug products. These qualification processes involve extensive documentation and testing, often consuming significant time and internal resources. Thus, to minimise time and expense, pharmaceutical companies frequently validate only a limited selection of containers, resulting in situations where the containers used are not optimised for the specific product being shipped. For instance, a half-empty box may be shipped because smaller, more appropriate containers were not validated despite being available. Additionally, manufacturers often choose single-use solutions for convenience, which raises sustainability concerns due to the waste generated.
Addressing the complexities of clinical trial shipping requires careful consideration of container selection to ensure alignment with the specific needs of the product being transported. Fortunately, pharmaceutical cold chain solution providers are continuously working to bridge this gap, helping manufacturers match the right solution to their products seamlessly.
Staying informed about the latest innovations in product design and material choice is essential for moving towards the optimal solution for clinical trial samples.
