By Cytiva
The VIA Capsule™ system provides a patient centered way of transporting cellular therapies.
Cellular therapies have the potential to transform global healthcare. With cell therapies being approved by regulatory bodies in the United States, the European Union, Canada, Japan and Australia1, and hundreds2 more in clinical development around-the-world, we will continue seeing global regulatory approvals. Despite the potential of these therapies, the workflows have not advanced as quickly as the science.
One of the challenges in cell therapy manufacturing is the need to maintain cryopreserved samples at ultra-low temperatures, below -120⁰C, during transportation between the clinical collection and treatment sites and the manufacturing facility. Traditional cryogenic shipping methods use liquid nitrogen (LN2) dry shippers which require labor intensive preparations, careful handling and a rigid logistics schedule to ensure the shipper maintains cryogenic temperature during transit.
Cryobiologists at Cytiva quickly realized that to make cellular therapies more accessible, shipments must be simplified without compromising the cryogenic temperatures needed to maintain quality. So we created the VIA Capsule™ system. It is charged using standard electricity which simplifies the preparation and scheduling of the shipment unlike a traditional LN2 dry shipper. With a continual data feed from the VIA Capsule™ shipper’s smart monitor, the exact time remaining within the critical cryogenic temperature range is determined and displayed within the Chronicle™ cloud-based software to provide a level of visibility over the shipment that is not possible with traditional LN2 dry shippers.
Recently, CSL Behring evaluated the VIA Capsule™ system against a conventional LN2 shipper and discovered significant logistical advantages. While post-thaw viability was comparable, they identified that the VIA Capsule™ system’s capacity to store samples at cryogenic temperatures for extended periods benefits sites without temporary facilities or those ill-equipped for managing LN2. In addition, its size and mobility made it easier to handle and load samples.
Timing a sample collection for patients who qualify for a cell therapy clinical trial of treatment can be difficult. Using the VIA Capsule™ system for temporary cryogenic storage creates flexibility with scheduling because (when connected to a standard electrical outlet) it maintains cryogenic temperatures, while waiting for the best time for patient’s sample to be collected or treatment delivered. At the manufacturer’s site, this capability also removes pressures to coordinate workflow with shipment timings. This approach reduces the number of breaks in the sample’s chain of custody while maintaining a single chain of identity from the manufacturer to the patient’s bedside.
Maintaining quality throughout the vein-to-vein workflow is fundamental to the success of cell therapies. The VIA Capsule™ system provides a controlled, reliable and patient-centered way of transporting and temporarily storing therapies. Now available in the US and Europe, cell therapy manufacturers can run their own VIA Capsule™ system evaluations to explore the benefits of smart, LN2-free shipping to their workflow. To request further information or arrange to trial the system please register here.
1 GlobalData
2 Alliance for Regenerative Medicine Annual Report 2020
