The healthcare industry is currently benefitting from ground-breaking developments in new areas of medicine such as cell and gene therapies, and the value they offer for patients suffering from difficult to treat or rare diseases is incontestable. Driven by technological advances in methodologies, an expanding number of next-generation clinical trials are being conducted worldwide.
We know that the specificities of these therapies make them distinctly different from traditional medicinal products and that supporting these studies requires a specific approach to clinical trial supplies management. Read on to discover how to preserve the integrity of your product throughout the various stages of the clinical supply chain.
Supporting cell and gene therapies requires specific frozen cold-chain and storage capabilities alongside stringent SOPs for clinical trial supplies management processes.
The medicinal products used for such trials tend to have a lower stability. As such, preserving the integrity of the sensitive materials which are manipulated throughout the supply chain is crucial to the success of a trial. In other words, avoiding temperature excursions is paramount.
The storage and distribution of cell and gene therapies require ultra-low temperature capabilities. Depending on the therapy, specific temperatures and methods are required: cell therapy requires 180°C capabilities (cryogenic storage), and gene therapy requires -80°C storage capabilities.
Choosing a storage and distribution partner with the required authorisations and capabilities to support these requirements is therefore key. Clinigen’s global network, with facilities in the US and Europe, is fully equipped and experienced in these areas. We have freezer capacity in the US and Europe at a variety of temperatures, including -80°C. In addition, we are equipped with liquid nitrogen tanks.
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You should also ensure your provider has the required SOPs in place to maintain the integrity of trial materials being handled during the study's various clinical supply chain management stages. At Clinigen, our teams follow rigorous cold-chain-management practices. And to ensure clinical materials are protected during frozen storage, we have a 24/7 environmental monitoring and security system as well as controlled access throughout our facilities.
Maintaining ultralow frozen temperatures throughout the packaging and labelling process requires specialised technologies due to the logistical constraints of such conditions (for example, label adherence is to be considered). At Clinigen, Investigational Medicinal Products (IMPs) can be packaged and labelled over dry ice, which excludes the potentiality for temperature excursions.
For -180°C projects, we utilise advanced technology to ensure the ultra-low temperature conditions can be met while handling is required by our teams. When a cryobox is removed from our liquid nitrogen tank, the extreme temperature requirements are maintained thanks to cryogenic carriers. These LN2 vapour-based carrier boxes provide a safe, portable, and trackable solution for transferring temperature-sensitive biological materials. These carriers enable us to maintain a maximum temperature of -150°C while the products are outside the liquid nitrogen tank. The cryogenic carrier displays and logs temperature and emits warnings when temperatures near thresholds.
For a biotech developing gene therapy for rare diseases, Clinigen implemented an innovative solution for carrying out the packaging and labelling of their product over dry ice, all while simultaneously ensuring cost-efficient storage and distribution for their global study.
To safeguard your medicinal product against temperature excursions, ensure your service provider utilises advanced distribution solutions to maintain required temperature thresholds throughout shipping and distribution. Clinigen’s validated shipping systems and procedures provide safe and efficient global distribution along the entire cold chain. For example, during transport, we employ temperature-controlled dry shippers.
See below a high-level overview of a storage, labelling and distribution process implemented by Clinigen for a past client:
Clinigen has the flexibility, tools, and proven qualifications to handle Phase I to Phase IV projects. With 25-plus years’ experience and global capabilities, we ensure efficient packaging, labelling & storage programmes which are fast, waste-free, and always on time. We adapt every clinical supply strategy to the particular needs of the trial and oversee the entire study from start to finish, acting as our client’s advisor at every step of the way.
What are your clinical trial requirements? Speak with one of our clinical trial supply experts to discuss adapting a clinical supply strategy to your study.
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