Tested for safety to give you certainty
Temperature-controlled packaging and labelling services to ensure end-to-end compliance
At Cryoport Systems, we provide custom drug packaging and labelling services for your clinical trials and commercial regenerative therapies. Our BioServices team can provide standard and custom drug packaging and labelling solutions for vials, bags, and other containers. All can be designed to meet the requirements of your study protocol.
We carry out all our packaging and labelling activities at the appropriate temperature. This ensures that your product doesn’t experience any temperature deviation when processed for shipping. We can also help you with label text design, translations, blinding, and regulatory support.
A complex process made simple at Cryoport Systems
Validated packaging and labelling at ultra-cold and cryogenic temperatures
Labelling at cryogenic and ultracold temperatures can make drug packaging and labelling quite complex. The chosen labels need to be validated to perform at ultra-cold temperatures. Additionally, determining the application process and container type can have a significant impact on long-term adherence. Your labels need to endure not just cryogenic storage temperatures but also the ability to withstand rapid warming during the thawing process. The personalized nature of medicines and the limited options for over-labelling once the materials are frozen mean that selecting the right label first time is crucial.
Packaging Center of Excellence
Our Packaging Center of Excellence can conduct label and packaging validation studies specific to your container type, which will ensures optimal packaging performance and label adherence. We can also advise you on optimal packaging design for specific primary packaging configurations.
At Cryoport Systems, we recognize that many advanced therapies require administration very soon after patient enrollment. We can develop product-specific workflows based on your processes to get therapeutic products packaged, labelled, and shipped in as little as a few hours.
We can create ‘late stage’ custom protocols to perform certain modifications to clinical supplies such as label application to patient kits that have already been released. These just-in-time services can be essential for certain advanced therapy trials and provide added peace of mind.
Global Network of Experts and Facilities
We have facilities across the world supporting ambient, refrigerated, and frozen packaging to accommodate local and regional requirements.
We actively monitor all our temperature-controlled packaging and labelling operations. Our environmental monitoring system and temperature records are documented throughout the process to ensure that critical time-out-of-environment specifications are met.
Our highly trained logistics experts handle the distribution of all types of packaged and labelled medicinal products for clinical trials. They can also offer their considerable expertise and proficiency in import / export documentation, trade compliance, and customs requirements to reduce the risk of delays to your shipments.
From express carriers to specialty courier services dedicated to the global transportation of pharmaceutical products, we only work with carefully chosen and approved distribution partners. We use a full range of validated shipping and packing configurations combined with precise multi-parameter, GPS-enabled, condition monitoring systems to make sure your medicinal products arrive at their destination in the best possible condition.
