Cryoport Systems is making waves in the world of gene therapy with its new Elite Ultra Cold shipping system, not least because it tackles the unique challenges of transporting high-value, temperature-sensitive goods.
Mike Dybicz, Senior Vice President and Chief Product Development Officer, and Khoa Tran, Director of Product Marketing and Management, discuss the critical features of the Cryoport Elite.
Developed in response to market needs, the new system offers extended hold times, enhanced security and integrated condition monitoring – all crucial for maintaining the integrity of gene therapies during transit.
During the discussion, the Cryoport duo emphasizes the importance of collaboration in product development. Working closely with clients, they've created a shipping system that not only meets current needs, but also anticipates future challenges in the gene therapy space. Key innovations include a patent-pending payload holding system, re-icing capabilities without compromising payload security, and real-time monitoring of various environmental factors.
"We really want to work hand in hand with our clients to bring new shipping systems online that have incredible features, that are smart, that have more integration and more capabilities," says Dybicz, highlighting Cryoport's commitment to ongoing innovation and partnership with the industry.
Angie Kalin: Welcome everyone. I'm your host, Angie Kalin with Fierce Biotech featuring Cryoport Systems. Today we'll be discussing Cryoport Systems’ approach to temperature-controlled supply chain solutions in a rapidly evolving gene therapy market. Joining us today are Mike Dybicz, senior vice president and chief product development officer, and Khoa Tran, director of product marketing and management. In this episode, we'll delve into the Cryoport Elite Ultra Cold Shipping system and its impact on gene therapy. Mike, Khoa, welcome.
Mike Dybicz: Thank you. It's a pleasure to be here.
Khoa Tran: Thank you. Thank you for having us.
Angie Kalin: Cryoport Systems is well known for its expertise in temperature-controlled supply chain management for advanced therapies, especially when it comes to cryogenic logistics. You recently launched the Cryoport Elite Ultra cold shipping system that uses dry ice instead of liquid nitrogen. Can you share the critical industry needs in challenges that led to the development of the Cryoport Elite?
Mike Dybicz: Yeah, thank you for the question. We, obviously, serve the cell and gene therapy markets, but the gene therapy market has really been in an accelerated evolution over the past decades and really the amount of clinical trials involving gene therapies has been growing every year, and these therapies target a lot of rare diseases and have really a high dollar value. They're usually shipped at minus-eighty degrees and need shipping systems that will ensure the payload integrity and the product integrity as well as understanding where the products are and the condition. The market has seen a ton of investment and we didn't have a shipping system that would address these market needs. Given the growth over the next five years, we wanted to make sure that we had a solution for this really critical market.
These dry ice shipments are mostly shipped using disposable shipping systems. With the growth of these gene therapies, the dollar value of each of these shipments, there is obviously a lot of challenges in using these types of shipping systems. For one, a lot of them are foam shippers, so they're thrown away every single time they're used, so they're single use. Their environmental friendliness is really not great, and a lot of our clients really care about their ECNG footprint. The shippers usually have just dry ice in the center capacity compartment, and therefore the payload is in direct contact with dry ice, which can impact labeling the packaging itself, et cetera. You can impact the condition of the packaging and for these therapies, you don't want to impact the labels that are present on the packaging. Most of these shipping systems don't have an integrated condition monitoring system, which means that the condition monitor is thrown in with the dry ice and shipped in the product payload.
The payload can move around not with the condition monitor, so you're not getting a true sense of the temperature that the payload is seeing versus the condition monitor. That's a really important thing to ensure the quality of the payload. Realistically, these shipping systems, because of these dynamic factors, the hold times may not be exactly what the shipper is designated to be because you have payload moving around, you have dry ice resettling, so you're not getting that consistency to the actual payload of the temperature, which we really didn't obviously like. We wanted to come up with a system that didn't have these deficiencies. Then the last thing that's a really big one for most of our clients and we address with all of our shipping systems is the ability to access the payload during transit.
Angie Kalin: Khoa, as the product manager for the Cryoport Elite, how did you take the needs of the market and needs of your clients and turn that into the next generation shipping system customized for gene therapy?
Khoa Tran: Yeah, we did spend a lot of time interviewing clients and potential clients to understand some of their pain points. What were some of the gaps there in the market for the dry ice shipping solutions out there? At the same time, we were also doing a lot of market research to see what are the different solutions in the market and what was missing and what were those gaps. We discovered that most of the clients were using the disposable dry ice solutions and were looking for a more eco-friendly, reusable solution as Mike alluded to earlier. With that, we ran into a lot of clients saying that these come in every day and they have no place to throw them out, and their trash area is full of just these disposable single use packages. They were looking for something that was more reusable that they can ship back and be able to take in without having to throw it out every time.
Another functionality that they wanted to be addressed was the resiliency of hold time to accommodate normal transit handling and sometimes even the possible delays. As we all know, logistics, you never know what you can get. There could be delays with weather handling some of the integrators that are used out there. Having that little bit of buffer of hold time was important to a lot of the clients that we spoke to because things could be held in customs and wouldn't be checked out. That was also a concern of theirs. We wanted to make sure that we developed something, created something that was going to address those concerns. Then we wanted to provide some consistency and performance. Usually with dry ice, it can move around in transit. We wanted to make sure that the payload would not also be in contact with the dry ice.
Mike mentioned earlier before when dry ice touches some of these packaging labels, it could smear some of the batch, lot numbers, serial numbers could be affected when dry ice is touching some of these labels, this packaging. We wanted to make sure that we could provide dry ice cooling and performance, but actually not touching the packaging itself or the therapy itself, what's inside the shipping system. One of the big things that really came up from our interviews and conversations with some clients was that payload security was also an issue. A lot of times these packages and shipping solutions are styrofoam inside a cardboard box and tape is just used to close the cardboard box to secure it. You might have a tamper evident seal.
What is also important is that you don't want whoever is transporting the shipping system have access to it or be able to access it. We wanted to make sure that some of these high value irreplaceable commodities were going to be secured during transit. That was something that we wanted to make sure when developing a shipping system that this was going to cover, was that the availability to not make it so easily accessible to just the normal person handling this shipping system.
Angie Kalin: Building on that, it's clear that this next gen shipping system is addressing critical needs in gene therapy logistics. How has this been received by clients and how has this influenced your approach to the broader market?
Mike Dybicz: I think we've had a great reception to the shipping system that we've developed, and when we were considering the development, obviously we wanted to do that with a partner. We worked with a client partner to validate those market needs that Khoa was talking about. Existing solutions that are in the market really did not meet the needs that they had articulated for their therapies. They were either disposable, as Khoa had mentioned, they didn't have integrated condition or location monitoring, they really didn't address those product security features that Khoa mentioned just a bit ago.
The robustness, again, Khoa touched on that tape in a cardboard box, if you're in a rainy environment, that's not going to be a pretty stable shipping system to transport this high-value therapy. Really, the performance, the aesthetics, the reusability that really didn't align with what was in the market. Really, when you talk about these high-value biomaterials, you want to find an offering that is compliant with ISO 21973 to have that same level of security, peace of mind, reusability, the usability as well, and the aesthetics. That combined with our service levels and our integrated condition monitoring, which is what we do with all of our shipping systems, was the ethos in which we approached this product and there definitely was, and a gap in the market for dry shipping systems that incorporate these robust features.
Really, it's all about mitigating risk. You have a high-value, high-impact therapy, and that's really where this whole thing started, right? You want to have a shipping system which helps us to enable the outcome, which is something we say in the market. That supports the gene therapy, the viral vector markets. As noted before, these are seeing explosive growth, a lot of clinical trials, only a few commercial, but they're coming and these have a profound potential to impact people's lives. We wanted to make sure that we had a shipping system that obviously treated those lives with the equal care that we want to and our clients want to.
We did see a lot of challenges here in making and developing this product. There were a lot of engineering and other thermodynamic performance requirements, and we did overcome them as we were going through this, manufacturing, assembly, really, we really pushed the limits of how we were manufacturing this product to make sure we got a world-class shipping system with the performance that our clients and our teams expect, and we're very excited about what we've developed. It was greatly influenced not only by the market, but also by real clients that are developing and commercializing gene therapies.
Angie Kalin: It sounds like that collaboration really played a key role in refining the Cryoport Elite as it was being developed. Can you walk us through how you worked together with this client, particularly the qualification process and how that partnership helped to fine tune the final shipping system?
Mike Dybicz: That's a great question. Really, we started this as very collaborative. Our consulting services team took on the challenge and we worked closely with engineering, product management in the conceptualization, the design, the qualification of the shipping system. We started obviously with our understanding of the market and our clients requirements that we've collected through our VOCs for what Khoa was mentioning earlier, that engagement with the market, but also the immediate needs that were articulated by the partner that we've worked with in its development.
We think of this as a little bit of a forward-thinking mindset that helps us to create solutions that can truly scale to how the market is going to be growing. We have a lot of competencies ranging from program management, validation engineering, packaging engineering and data services. We really work collaboratively in a project-based structure. That's really important because as we've grown, it's really that collaboration with lots of, hundreds of companies, in all phases of clinical and commercial development. That work as evidenced itself also in the qualification. When you develop a shipping system like this, you have to ensure that what you build is what you intended to build, and then you have to verify it empirically.
That's what we do in consulting. We do a data and scientific-based approach to mitigate risk. We worked with this partner of ours at all stages of development where we followed our comprehensive shipping system, our lane qualification and validation processes for the shipping system, for the product, for the packaging, and for the shipping lanes. This involved physical and thermal testing as well as custom testing. When you're building a shipping system, you have to map the interior to understand how the temperature is distributed within there. You have to figure out where you're going to put the thermocouple, which is going to measure the temperature, and you got to verify that location is a good indicator of what the payload is seeing. We did all that and there's lots of testing that goes around that internally and then in a controlled laboratory environment and then in a real-world transit environment, so there's extensive testing that you have to do.
Physical testing as well, you have to do things like vibration testing and drop testing to make sure that the shipper can handle the rigors of the transit environment. These are all things that as we move through this process, it's really collaborative. It's really working with our clients. We always are quality-driven in what we are doing, and that is also very collaborative with the clients as well as with our internal teams.
Angie Kalin: You mentioned collaboration with your consulting services team. How did that collaboration and the insights generated get integrated into the system's design?
Mike Dybicz: It's a good question. Every day with consulting, we are working with our clients at all stages of clinical and commercial development with different types of therapies that range from different therapeutic targets, etc. What we do is we really assess, we quantify and then we build risk mitigation plans at its core. You do that by trying to understand the problem and obviously employ best practices in that process. As you're doing that, you understand the market and some of the concerns of the market, some of the sensitivities of different types of products. We have obviously our own packaging team and all of that helps to bring to bear when we're building a shipping system to help bring that into the design process. If you're shipping on a certain lane and a lane is really like a source and a destination site, and then all the stops in between, when you're doing that, and we're doing that work every day in consulting, you get to learn the dynamics that a shipper will go through.
Those things come into the product development and have come into this product development process which relate to courier performance, site handling, how things are processed, the timing and all of that, even when you look at the shipping system handles latching, how do you secure the materials, how do you provide security in the event of some unforeseen transit event? All of that comes into really how the system design was informed by our experiences of our amazing consulting team. We bring that to bear here and we've incorporated many years of best practices with working with these companies at various stages of development, and particularly the unique sensitivities around the manufacturing, the storage, the clinical sites and the manufacturing sites. That had been really a force multiplier for us, and we wouldn't have been able to develop this shipping system without our internal consulting services capabilities.
Angie Kalin: With all these collaborations and insights shaping the development, I'm curious what specific features came out of this process to make the Cryoport Elite stand out in the gene therapy space?
Khoa Tran: Yeah, great question. One of the key features to ensure the integrity and the viability of these therapies was the design of our patent pending payload holding system. The payload holding system provides a degree consistent cooling around the payload without directly making contact with the dry ice. It also immobilizes the therapy within the shipping system as well. It provides that integrity throughout the transit of the therapy. One of the things that we do at Cryoport Systems is that even before sending out any shipping system, not only the Cryoport Elite Ultra Cold shipping system, is that we make sure that each shipping system is re-qualified to provide consistent performance for every shipment. One of the aspects that we have is that we have this process called the very clean process, and what it does is we reprocess the shipping systems between shipments and eliminate any type of cross contamination, as well as with our condition monitoring system, we make sure that the battery is full before it goes out on any shipment.
We have an extensive re-qualification process that we do to make sure that when the client receives any of our shipping systems, that it has been verified and ready to go, and it's in tip-top shape performance. Then with the hold time, right? We qualified the hold time for the shipping system to exceed the industry standard. The Cryoport Elite Ultra Cold shipping system has been qualified for any type of shipping challenges, international shipments that we might see. The 28-liter shipping system has a minimum of 140 hours of hold time while the 56 liter has a minimum of 185 hours of hold time. Even though the hold times exceed the industry standards, we wanted to make sure that clients would have the ability to re-ice the shipment without accessing the payload.
As Mike mentioned earlier, we wanted to provide this feature for any critical shipments that might be out there. You have a lot of high value irreplaceable commodities, so you don't want anybody just being able to have access to these commodities when they are in transit. We wanted to make sure that at any point in time if a shipment gets delayed in customs or gets delayed for any type of unforeseen circumstances, that you had the ability to re-ice at any point in time without actually getting access to that payload. One of the key innovations as well with just all our shipping systems and not just only the Cryoport Elite, is that we provide a near real-time temperature monitoring system as well as an external display. In this external display you'll see the internal temperature. Some of the features of our condition monitoring system that we have is that it'll provide you visibility of the shipment at any point in time.
Some of the informatics that you'll get from this is internal, external temperature, pressure, tilt, shock, humidity, and even the location. Throughout the whole journey of the shipment, you'll be able to see all this data, all this information to make sure that once it arrives to that site that the integrity and the viability of that therapy was intact. That allows you to do that without actually opening up the shipping system at any point in time. This helps mitigate any of the risks and make sure that once that therapy arrives, that it's ready to go for that patient on the other end. Safe transportation and maintaining product viability is paramount. For all that we do here at Cryoport Systems, with that, the Cryoport Elite shipping system also falls in that line of the Cryoport Systems family.
Angie Kalin: As we all know, the field of gene therapy and biotherapeutics continues to evolve quickly. How do you see the Cryoport Elite shipping system adapting to keep up with those advancements?
Mike Dybicz: We always have to be watching the market and obviously the gene therapy market is evolving daily. We expect that as we move forward, we're going to be integrating and iterating on the development of this shipping system. Things that are already on our plate are enhanced mobility features. We want to map out and better optimize our manufacturing to make that easier and more cost-effective to manufacture and to just incorporate some niceties that we've learned over the years to integrate. We've also gotten client feedback, as we noted earlier, that we've seen great client uptake on the shipper, and so we've got feedback from clients that we want to integrate into our product lifecycle.
We really are very excited to extend the product line in the future. Two things that are definitely on the plate as well are a smaller and potentially a larger, which our clients have identified. This is one of our pride items. This is the first in the line of our elite shippers, and we're really looking forward to collaborate, learn from, and innovate with our clients as well as the end users because that's the best way to develop a product that's actually going to be used to make sure that we build the right solutions that deliver real value, solve real challenges, and hopefully have a positive impact on patients.
Angie Kalin: What future innovations can we expect from Cryoport Systems in the realm of shipping systems, particularly for the advanced therapies?
Mike Dybicz: The market is growing and it's also seeing different needs coming from the different therapeutic targets. The different therapies have different manufacturing processes that are changing, and we are always working with our clients to make sure that our products and services are evolving at the same pace or hopefully ahead of what the market is seeing. We're building our product roadmap to extend the features, to incorporate learnings, to understand those pain points. We really want to work hand in hand with our clients to bring new shipping systems online that have incredible features, that are smart, that have more integration and more capabilities.
Obviously, along with the shipping systems, we also are developing some pretty exciting accessories. These are things that work in concert with the shipping systems. One of those is our new non-metallic manner to immobilize the payload that goes into these shipping systems, and we call it the SafePak system. That is a pretty big innovation that we'll be launching this year. We think it's going to have a profound impact on the market, and it has features that don't exist in the market and should hopefully help with product integrity. Long term, we really want to build on the innovation that our teams have built over the many years that we've been in business. We obviously have industry leading experience collaborating with our clients, and really we want to make sure that the products address real challenges and real opportunities that our clients present to us.
Angie Kalin: Thank you so much, Khoa and Mike for offering such valuable insights into the Cryoport Elite Ultra Cold shipping system and its impact on the gene therapy field.
Mike Dybicz: Thank you so much. We look forward to hearing from your listeners and hopefully working with some of them.
Angie Kalin: It is clear that Cryoport Systems is not just addressing today's needs, but is also ahead of the curve with forward-thinking solutions. Your dedication to enhancing gene therapy through secure and efficient logistics is truly impressive. We're excited to see how Cryoport Systems continues to drive innovation in the biopharmaceutical world. This has been Fierce Biotech with Cryoport Systems. For more information about the Cryoport Elite Ultra Cold shipping system, or if you want to connect with the Cryoport team and their consulting services, head over to cryoport.com, Mike, Khoa, thanks again to you both for being with us today, and thank you all for listening. We'll catch you next time on Fierce Biotech.