Engineering for Impact: A Conversation with Mike Dybicz on the HV3 and Safepak Systems 

When it comes to cell and gene therapy (CGT) logistics, innovation is about more than improving efficiency, it’s about safeguarding a patient’s only chance at treatment. The Cryoport Express^® Cryogenic HV3 Shipping System and Safepak^® System 1800 are two of Cryoport Systems’ latest advancements, designed specifically to reduce risk, increase reliability, and ultimately improve patient outcomes. 

We sat down with Mike Dybicz, Senior Vice President & Chief Product Development Officer, to discuss the development of these systems, the patient-first approach behind them, and how Cryoport Systems is reshaping the future of CGT logistics. 

Q: Mike, what was the driving force behind the development of the Cryoport Express^® Cryogenic HV3 Shipping System? 

Mike Dybicz: The HV3 system was born out of a very simple but critical question: How do we remove every possible barrier that could delay or compromise a patient’s therapy? 

We know that flight availability is a key challenge in CGT logistics. The size and shape of a shipping system can determine whether a therapy gets on a plane or gets delayed. We redesigned the HV3 system to optimize for better cargo acceptance so that therapies have greater flight availability and fewer transit disruptions. 

Another factor was the human element. It’s about so much more than how the shipper functions, it’s about how it fits into the workflow of the pharmacists, clinicians, and logistics teams handling these therapies. That’s why we built mobility features directly into the design. Instead of requiring extra equipment to move it, the HV3 has integrated wheels and an adjustable handle, making it much easier to transport through hospitals, pharmacies, and clinics. 

Q: What are some of the biggest risks the HV3 system mitigates? 

Mike Dybicz: Product integrity is always the priority. Advanced therapies, especially autologous cell therapies, can’t be replaced. If a shipment is compromised, it’s not just a simple delay that we’re talking about, it’s a patient’s treatment that may no longer be viable. The HV3 system was designed with multiple layers of risk mitigation at every turn, including features like optimized thermal performance to maintain temperature stability, enhanced immobilization to prevent movement during transit, and tamper-resistant security features to prevent unauthorized access. 

We also built requalification into the process. Every HV3 shipping system is validated and requalified after every use, ensuring it meets the same high standards for each new shipment. Our validated and proprietary Veri-Clean^® decontamination process eliminates cross-contamination risks, which is critical for maintaining chain of custody and protecting patients. 

Q: The Cryoport Safepak^® System is another major innovation from Cryoport Systems. What challenge does it solve? 

Mike Dybicz: Blood bag breakage is one of the biggest hidden risks in CGT logistics. Most traditional systems use metal racks inside metal-lined shipping containers. The problem with this is that metal-on-metal transfers force, which increases the risk of bag rupture during transit. 

The Safepak System eliminates that issue by removing metal from the equation. Instead, it uses a cryogenic-friendly material that absorbs shock and minimizes force transfer. This provides a much higher level of protection for fragile blood bags. 

We rigorously tested the Safepak System to IATA drop standards, meaning we repeatedly dropped it from four feet, which is the standard test height for shipping durability. The result? Zero blood bag breakage. That’s a major milestone for patient safety. 

Q: How does the Safepak System impact the patient experience? 

Mike Dybicz: When a blood bag breaks in transit, this goes beyond a logistics or packaging issue. It’s a devastating failure for the patient waiting on the therapy. 

Many of these therapies are autologous, meaning they’re derived from the patient’s own cells. If the bag is damaged, that patient might not have another opportunity to receive treatment. 

By significantly reducing the risk of breakage, the Safepak System helps ensure that patients receive their therapy intact, without unnecessary delays or disruptions. It’s about making sure that every step of the supply chain protects what’s inside, because what’s inside is a patient’s future. That’s a responsibility that we take very seriously, we understand the importance of what we’re transporting and the trust that’s being placed with us.  

Q: Cryoport Systems often talks about Enabling the Outcome™. How do the HV3 and Safepak System fit into that mission? 

Mike Dybicz: Enabling the Outcome™ means designing every part of the supply chain with the patient’s success in mind. It’s not as simple as moving shipments from point A to point B, it’s about ensuring that life-saving therapies arrive exactly as intended, every time. The HV3 and Safepak System were both developed with that philosophy.  

The HV3 increases patient access by improving flight availability, handling, and security. The Safepak System protects therapies from physical damage that could make them unusable. 

Together, they represent the next generation of patient-focused logistics. Every design choice, every test, every feature was developed with one goal: to deliver therapies safely, reliably, and without compromise. 

Q: What’s next for patient-centric innovation at Cryoport Systems? 

Mike Dybicz: We’re constantly listening, learning, and innovating. One of the biggest areas of focus moving forward is real-time visibility, giving therapy developers, clinicians, and patients greater insight into where their therapy is and its condition at every moment. 

We’re also expanding our global infrastructure to ensure that more patients in more regions have faster, more reliable access to CGT therapies. The goal is to stay ahead of industry needs and continue building solutions that remove risk, improve efficiency, and most importantly, protect the patient. 

 As advanced therapies continue to transform medicine, Cryoport Systems remains committed to innovation that safeguards patient outcomes. The Cryoport Express^® Cryogenic HV3 Shipping System and the Cryoport Safepak^® System represent the next step in securing the future of medicine and ensuring that every patient receives the therapy they need, exactly as intended. 

A special thank you to Mike Dybicz for sharing his insights on how Cryoport Systems is driving patient-centric innovation in CGT logistics.