In a recent article, Colin Enz, CSM Validation Manager & Russell Brierley from Lupin Research Inc talk about the key challenges involved in handling cryogenic products and how to address them:
With the rise of cellular therapies and individualized medicine, cold chain study management has become a common issue in the clinical trial setting.
There are many great standards to use when it comes to cold chain supply at -70C and colder, unless there are special requirements. From product stability, clinical packaging and labeling to product distribution, there are many factors to be considered when handling cryogenic pharmaceutical products.
When it’s time to package, it’s all about exposure. If your study requires secondary packaging, reducing exposure becomes an even larger concern.
When formulating secondary packaging, shipping methods should always be kept in mind. The limits of shipping containers in the -70C and cryogenic realms are much tighter than in other, warmer ranges.
For product labeling you need to make sure that it will stand-up over your storage and use time and printed labels have to be appropriate for these conditions.
When developing your cold chain distribution processes, understanding the limitations of your shipping methods and monitoring devices is key.
Overall, careful considerations should be made well prior to the start of a clinical study with an ultra-low or cryogenic product. Developing stability studies and allowed temperature ranges/excursions ahead of time is critical. Working with a supply chain service provider that is already experienced in cold chain packaging, cryogenic storage systems and cold chain logistics will allow for much smoother cold supply chain logistics.
A Reliable Partner to Provide Cold Chain Services
With 20-plus years’ experience handling cryogenic pharmaceutical products, CSM developed reliable and innovative cold chain services, and can help you with your study’s specific needs.
We have an extensive list of available packaging, labeling and distribution services for all of your temperature-sensitive requirements worldwide. In addition, CSM can easily arrange for the delivery of your clinical trial’s products through temperature-controlled shipping solutions.
Speak to a CSM expert about cold chain study management needs and discover our tailor-made solutions.
“I want to thank you for the great cooperation and your never-ending efforts regarding our global Phase II study. Even in difficult situations and in case of urgent issues CSM is supporting us, always trying to find a solution.”
—Heike Schön, Clinical Research Consultant (external), Glycotope GmbH