“To support life and health on earth by providing reliable and comprehensive logistics solutions for life sciences” is the mission of temperature-controlled logistics company Cryoport.

The US-based company is the life science industry’s most trusted global provider of temperature-controlled logistics solutions for temperature-sensitive life sciences commodities. Cryoport serves the biopharmaceutical market with leading-edge logistics solutions for biologic materials, such as regenerative medicine, including immunotherapies, stem cells and CAR-T cells.

Its solutions are used by points-of-care, CROs, central laboratories, pharmaceutical companies, manufacturers, university researchers et al; as well as the reproductive medicine market, primarily in IVF and surrogacy; and the animal health market, primarily in the areas of vaccines and reproduction.

Cryoport’s proprietary Cryoport Express® Shippers, Cryoportal™ Logistics Management Platform, leading-edge SmartPak II™ Condition Monitoring System and geo-sensing technology, paired with unparalleled cold chain logistics expertise and 24/7 client support, make Cryoport the end-to-end cold chain logistics partner which the industry trusts.

Jerry shelton high res headshot

Source: Cryoport

gasworld spoke to Jerry Shelton (left), Cryoport’s CEO, to find out how the latest regenerative medicines wouldn’t be possible without an often overlooked, yet extremely important component: logistics.

Firstly, where does Cryoport operate from? What is the company’s footprint globally?

Cryoport is headquartered in Irvine, California, with operations in Singapore, Amsterdam and soon to be in operation in Livingston, New Jersey, very close to Morristown. From these strategic locations, we serve over 100 countries.

Can you tell us how Cryoport is playing an essential role in regenerative medicine in a very unique way?

The uniqueness in the way we are playing our supporting role is in these new miracle therapies. Right now a lot of attention is centred around CAR-T cells and our support of their delivery with temperature controlled logistics.

In that role we’re unique, no one in the world competes with us head to head across the board. We have a lot of trade secrets and industry know-how and we apply that in our packaging, in our information technology and in our logistics expertise. So, to have a truly temperature controlled, bona fide, verified, validated temperature-controlled logistics system, you must have the appropriate packaging first and we call that packaging shippers. Those shippers are complex devices which include mechanical engineering, packaging engineering, electronic engineering and physics. Then you go from those sophisticated packages to information technology.

We’re powered by the most superior platform for logistics management in the entirety of the pharmaceutical industry and it is called a Cryoportal. The Cryoportal, our central nervous system, supports our entire shipment and logistics process through a single interface, including initial order input, document preparation, customs documentation and clearance, carrier integration, courier management, shipment tracking, intervention support, issue resolution, and delivery. It starts communicating, once the shipper gives permission, with the SmartPak II condition montoriing system. The SmartPak II is a real time data monitoring system which collects data and transmits the conditions in which the materials are being shipped in real time. We do that through cellular networks, Wi-Fi, and GPS. We can locate a package at anytime, anywhere in the world, and tell the client the conditions to which their material is being exposed while it is being shipped.

That’s the sophistication and that’s a uniqueness which Cryoport provides.I For these biologic materials, the only way to tell that you have delivered them in a state in which they can deliver the efficacy with which they were manufactured, is to provide the data. Because, if there had been a temperature excursion, you would never know it except for the data. They don’t change colour and they don’t smell, so there’s no indication except by looking at the data which our SmartPak II provides. And, we provide that crucial data on the chain of condition and the chain of custody as well as other information on shock, vibration, pressure, exposure to humidity, openings, anything that the client wants to be programmed I;, then we can monitor it with our sensors in our electronic monitoring system.

Cryoport hq in action

Source: Cryoport

How were regenerative medicines transported to patients before Cryoport provided a delivery solution?

Novartis’ Kymriah and Gilead Kite’s Yescarta were the first two commercialised therapies in the regenerative medicines space. For the most part, there was no real regenerative medicine out there so there was no transport. How would you have transported it absent of Cryoport? Well you would have transported it in liquid nitrogen and you would have strapped a passive data logger on the outside of the dewar to try to accomplish that. But, that’s much more complicated than it sounds and less effective than our system, so that’s why clients turn to Cryoport for their temperature-controlled logistics.

We understand Cryoport is the sole cryogenics logistics provider for the first two commercialised cell therapies for patients and the single largest cryogenic delivery system for immunotherapy drugs. Can you tell me more about this?

Well, that’s true and in addition to those two therapies that we support commercially, we expect another 5-7 Biologic License Applications or European Medicines Agency Applications to be filed this year. Most of them are current clients, so we expect to support more commercial therapies as they gain approval. We support 214 clinical trials in the regenerative medicines space, so we dominate that space by anyone’s measure. We cover most of the CAR-T cell trials which are in process that need logistics and temperature-controlled logistics. We do enjoy that position and we fight hard to maintain that positionthrough continually advancing our technology.

New cryoport dewar

Source: Cryoport

How are these logistics methods changing the future of biopharma?

Our logistics systems and the way we support the industry is not changing biopharma per se, however, what will happen, I think, and this is just strictly my forecast, is that biopharma will continue to evolve and the logistics needs will certainly be adjusted in the future. It is Cryoport’s mission to stay in a nimble stance and be ready to move in any direction in which the industry moves in order to continue to support the industry in this vital segment of logistics.

Can you tell me more about how cryogenics is incorporated into Cryoport’s delivery system? What quantities of gases are used, etc.? What does a typical Cryoport delivery van set-up look like?

We don’t own any vehicles. For our transport, we use about 250 outsourced solutions which are called couriers, integrators, freight forwarders and special couriers. Examples would be companies such as FedEx, UPS, DHL and others. We are carrier agnostic and it is often our client who chooses the vendor which physically transports our shippers. The power of our Cryoport Express shippers comes from holding liquid nitrogen in dry vapour form. The liquid nitrogen is absorbed in a calcium silicate type material in the inner walls and over the next 10 days or so the vapour evaporates. The vapour it gives off holds the temperature inside the inner chamber at about -196 degrees Celsius. Our shippers are engineered to hold that temperature for ten days in dynamic conditions and this is unusual because most holding time tests are done in static conditions. The word dynamic is important because our shippers are being moved around by third parties. We have to engineer them to absorb drops and other physical abuse which can happen as our shippers are being moved on and off of planes and in and out of vans.

Cryoport smart pak ii process graphic 8 1 16

Source: Cryoport

Is there any scope for Cryoport logistics outside of biopharma clinical trials? Any other potential markets?

We do serve two other markets outside of biopharma and we certainly serve markets outside of trials in biopharma. Let me take biopharma first. Outside of trials, there are cell banks, there are cell lines, there are all kinds of cells and cell-based materials that need to be transported and stored cryogenically, and we support those areas, too. It just so happens within biopharma the hottest area is immunotherapy and within immunotherapy it’s the CAR-T cell therapies.

The two other markets we serve are animal health and reproductive medicine. In the animal health area, it is primarily to support protein production in livestock and to support companion animals, primarily stem cell therapies for equine and canine. And in reproductive medicine, we primarily support IVF technology.

What is Cryoport focussing on at the moment?

We’re focussing on global expansion at the moment. We’re growing very rapidly and as I mentioned earlier we’re opening a new logistics centre in Livingston, New Jersey, and we’re upgrading our logistics centre in Amsterdam right now. My guess is that before the year ends, we’ll probably open another one or two logistic centres.

We’re always focussing on improving our technology at every turn because there are so many things happening in technology today that we can take advantage of to improve the security and the certainty that we promise to our clients.

Live view 2

Source: Cryoport

What does the future hold for Cryoport?

It’s really bright. Largely because these regenerative therapies are going through a massive transformation. Doctors who think about this and what’s going on in medicine will see this as a seminal time in the practice of medicine. These therapies will change the way medicine is practised forever. These events don’t come along very often and we’re at a time where we’re learning more about the body and how to bolster the immune system to fight these maladies. I was just talking the other day with Sanaira, a company which is developing a malaria vaccine. Malaria has been a problem for a very long time and now they are learning more and more about the body and how our biology works. We’re able to communicate with cells as we never anticipated before.

As we learn more and more about the materials we are transporting, how fragile they are and how finite they are, the more important Cryoport becomes because we provide the temperature-controlled logistics, which maintain the discoveries and the efficacy of the therapies which are being developed.We are in a vital place, an interesting place and the future for Cryoport is very bright.

Anything else you would to talk about?

Everybody has a vested interest in medicine and the advancement of medicine so everyone should keep their eyes on these fast developing - and when I see fast developing, they’ve been developing for many years but they’re just coming to the market now - therapies because they will change the lives of the next and they will change the way medicine is practised. They portend a fantastic future for Cryoport and its support role in this industry.