How Our Recent Innovative Solutions Meet Today’s Supply Chain Challenges
When advanced therapy organizations place innovation at the center of their approach to solving supply chain challenges, they prioritize the most important person involved – the waiting patient. An innovative, patient-centric approach reframes obstacles to focus on solutions that can ensure the vitality and protection of sensitive materials throughout every stage and phase of the journey to the patient’s bedside.
When considering common obstacles faced by the life sciences industry within the past year, clients’ needs pinpointed three pain points that affect certainty and safety for their patients throughout their supply chain. Cryoport Systems’ approach to establishing innovative solutions led to the development of new systems that directly solve pain points and instill protection for irreplicable materials across the supply chain for the betterment of patient health worldwide.
Challenge: New Airline Regulations Could Lead to Shipping Disruptions
The International Air Transport Association (IATA) imposes specific guidelines to ensure the secure and safe transport of biological materials via aircraft. These strict compliance measures encompass the shipment of all dangerous goods, a class of substances that includes biological specimens, therapies, and other material categorized as hazardous.1 Shipping systems transporting these materials must meet IATA’s specific requirements to ensure compliance. However, some life sciences organizations select systems that fail to comply. Shippers that don’t meet IATA standards introduce risk within a secure supply chain. Airlines may significantly delay or reject non-compliant systems, which in turn disrupts patient dosing timelines and incurs hefty fees.
Our Solution: Cryoport Express® Cryogenic HV3 Shipping System
Life sciences organizations require shipping systems that meet airline regulations while also going above and beyond to ensure therapy protection. To meet these strict compliance standards, Cryoport Systems developed the Cryoport Express® Cryogenic HV3 shipping system. This system is not only compliant with IATA regulations but also carries the CE (Conformité Européenne) mark, which demonstrates conformance with European Union health, safety, and environmental protection standards. Shipper accountability is paramount to successful transport journeys, and the HV3’s ability to meet compliance standards reduces the risk of added delays or incurred fees. Additionally, the HV3 was designed with dependability and ease of use in mind. Its top mating ridges and formed base allow for stacking and nesting, which optimize space both at client facilities and within aircraft. It has an integrated, front-facing handle and built-in wheels to increase mobility. These features reduce operator snag points for overall streamlined handling. Transporting biological commodities with the HV3 shipping system mitigates challenges with aircraft conformance without sacrificing total protection for the valuable materials. A shipping system of this caliber rethinks how certainty can be achieved during the shipment process so that irreplaceable materials reach the waiting patient without transport disruptions.
Challenge: Industry-standard Secondary Packaging Could Compromise Material Integrity
The fragility of materials used within the cell and gene therapy (CGT) industry constitutes shipping systems and accessories that can maintain material viability throughout the transport journey. Specifically, transporting blood bags for CGT development requires both dependable shipping systems and secondary packaging that work together to protect commodities. However, the use of standard metal racks to secure blood bags within shipping systems is of growing concern. While the shipper itself protects commodities from external harm, the blood bags risk being damaged or broken due to the shifting of the metal racks that are supposed to secure the product internally. Blood bags that are harmed by metal racks mid-transport aren’t discovered until the shipment reaches its destination. By then, the limited product is unusable, and the organization loses valuable time, resources, and certainty for their patients.
Innovation: The Safepak® System 1800
The reliability of the shipping systems and accessories used to transport sensitive CGT materials is of great importance. The Safepak® System 1800 is a secure secondary packaging solution that offers increased protection, ease of use, and an industry-first level of compliance adherence for product safety. The Safepak® System 1800 encompasses the Safepak® 1800 bag along with the SoftRack™ to create a new system for transporting fragile materials like blood bags. The SoftRack™ leverages soft, low-thermal materials as an alternative to metal racks to secure blood bags when placed inside the Safepak® 1800 bag. The Safepak® System 1800 prevents metal-to-metal and payload-to-payload contact to create a secure environment that safeguards the integrity of the materials. Altogether, the Safepak® System 1800 reduces the risk of material breakages mid-transport while its design minimizes the effects of vibration and shock events when transported within a Cryoport Express® High Volume shipping system. Cryoport Systems developed the Safepak® System 1800 in direct response to the CGT market’s request for a more secure secondary packaging accessory. This alternative system to metal racks reduces the likelihood of blood bag breakage. Its innovative design rethinks the scope of protection for irreplicable materials during transport to give CGT developers peace of mind that the systems they trust aren’t ultimately adding risk to the viability of their patients’ materials.
Challenge: Existing Dry-ice Shipping Systems Do Not Meet the Critical Demands of Gene Therapy Logistics
Gene therapies must be transported at ultra-low temperatures, oftentimes -80°C. Even so, many organizations leave temperature consistency up to chance. Packaging therapies in polystyrene foam and dry ice is a common shipment method within the CGT industry. However, this method introduces immense risk into the supply chain because it fails to guarantee stable temperatures or protect the commodity from unpredictable conditions during transport. This creates great fluctuation in how advanced therapies are managed throughout the supply chain with some organizations opting for a reactive approach rather than a proactive strategy that goes the extra mile to maintain consistency. The CGT industry requires a secure system to ensure consistency and security for these irreplaceable therapies that their patients rely on.
Our Solution: Cryoport Elite™ Ultra Cold Shipping System
The Cryoport Elite™ Ultra Cold shipping system meets the challenge of maintaining temperature consistency while offering ultimate protection for CGT materials. Unlike polystyrene foam systems that struggle to maintain adequate hold times, the Cryoport Elite™ can maintain low temperatures of -80 to -60° C for a minimum duration of 140+ hours. This extended hold time accounts for unexpected transport delays throughout the journey. Organizations gain peace of mind that their materials will remain at temperature even if delays increase the overall transit time. Beyond its hold time capabilities, the Cryoport Elite™ is designed with a robust exterior and features that facilitate streamlined handling to safeguard the physical integrity of therapies. The patent-pending payload holding system eliminates direct contact between the walls of the commodity while minimizing movement and shock events. This payload holding system also avoids direct commodity contact through a recharging process that re-ices the system without tampering with or removing the commodity. The Cryoport Elite™ provides the CGT industry with a secure packaging system that safeguards material viability. Its construction and features ensure consistency in comparison to alternative disposable systems that lack reliable, risk-mitigating features. The waiting patient can count on the safe delivery of their lifesaving therapies without fear that the shipping system entrusted to protect the materials isn’t capable of weathering the transport journey.
These innovative solutions were showcased at Advanced Therapies Week 2025 during an interview with leaders within Cryoport Systems called Latest Innovations from Cryoport Systems Enable Exceptional Patient Outcomes. As shared by Aruna Mor in the conversation, “We will continue to innovate and grow to provide best-in-class solutions to our clients as the industry moves forward.” As challenges arise that threaten the security of the life sciences supply chain, Cryoport Systems’ emphasis on innovation spurs cutting-edge systems to ease pain points, instill certainty, and support patient health. Ready to learn how the solutions in our integrative platform can meet today’s challenges? Learn more about our client-centric services.
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