With the rise of cell and gene therapies and individualised medicine, ultra-low cold chain management and product integrity are now central to clinical trial supplies planning. When products must be maintained at -60˚C and colder, the associated challenges of such conditions need to be considered when seeking to secure safe supply chain management for a clinical trial. Read on to discover what to look out for when planning a supply programme for a clinical study with an ultra-low or cryogenic product.
With low-temperature products comes the risk of temperature excursions. Product stability is crucial, and so your supply chain must account for and have processes in place to avoid temperature excursions at all points at which the products are being handled.
In addition, back-up supply should be considered to replace investigational products when temperature excursions do occur or if you haven’t yet done the studies to cover the excursion range. You should also have the ability to keep a record of these excursions and decisions on product use.
Choosing to label prior to initial freeze will greatly reduce the exposure to the product. When this is not possible, labelling post freeze should not be undertaken lightly. To ensure that your labelling will withstand storage and handling, the effects of the needed temperature conditions should be evaluated (for example, will the label adhere at frozen temperatures?). Work with a provider who has experience labelling post-freeze and has the technical capabilities to perform labelling at -60°C and lower.
Read our case study on packaging & labelling over dry ice
Again, it’s all about reducing exposure. If your study requires secondary packaging, reducing exposure becomes an even larger concern. There are many options for limiting exposure during secondary packaging, such as using specialised carrier boxes. Your supply partner should advise on the safest and most efficient options based on your product’s needs.
Secondly, your packaging and distribution partner should consider the shipping methods when advising on secondary packaging solutions. The limits of available shipping containers in the cryogenic realm are much tighter than in other, warmer ranges. Therefore, using a secondary packaging configuration that is standard to the transport container you will be using will make efficient use of space and optimise processes.
Understanding the limitations of your shipping methods and monitoring devices is essential and the reliability of monitoring devices should be discussed with your provider. While no device can guarantee 100% functionality at -180C, certain transport providers offer specialty services for handling ultra-cold shipments. Choose a clinical supplies distribution provider with a track record of shipping under ultra-cold conditions and a trusted partnership with specialised transport providers.
While the above considerations can seem logical (of course, you want to avoid temperature excursions!), streamlining the various stages involving the handling of your cryogenic product requires specific and standardised clinical supplies management capabilities. A provider which is specialised in ultra-low cold-chain management can work with you to develop detailed planning involving complex integration and coordination to optimise transitions as the product moves through the supply chain. For example, they can select specific routes in order to maximise cold chain performance.
Clinigen Clinical Supplies Management’s temperature monitoring solutions include single-use, multi-use, or active web-based monitoring for real-time details on your shipment, including location and when the package is opened. As a global provider, Clinigen handles clinical trial supply shipments to over 110 countries and combines market-leading clinical trial supplies like comparator sourcing, packaging and labelling with biological sample management.
Learn more about our cold chain capabilities
Our expertise extends into managing cell and gene therapy products. These products usually require extreme storage conditions only provided by liquid nitrogen, for which we have installed tanks at our facilities in Europe and the US.
From logistics planning and inventory control to packaging and labelling and project budgeting, we tailor our services to meet the exact needs of your clinical trial, which we oversee from start to finish. Working with a single provider can streamline processes, cut costs, and reduce timelines. But most importantly, you benefit from the added value of having a single point of contact who is committed to working closely with you and your team to better plan, prepare, and manage your study.
What are the requirements of your cryogenic product? We’d love to hear about your trial. Schedule a FREE assessment with one of our clinical trial supply services experts.
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.