With Gilead Sciences (NSDQ:GILD) and Novartis (NYSE:NVS) leading the way, cell therapies are moving on to the market and into the clinics for patients that have no other option. Companies making CAR-T therapies use a patient’s own cells to genetically engineer a cancer-killing cellular therapy that is then delivered back to the patient.
And one 55-person company is responsible for getting those products safely from the manufacturer to the patient.
Irvine, Calif.-based Cryoport (NSDQ:CYRX) plays a unique role in the biopharmaceutical industry. Using its cryogenic logistics technology, the company ensures that cell-based materials make it from the patient to the manufacturer, and back again to the patient, safely.
It’s an important job, CEO Jerrell Shelton told Drug Delivery Business News, because cellular materials will die very quickly if they’re not kept under the correct conditions.
“If you have a cell-based therapy, and if you want to get it from a point of manufacture to a point of usage, you have to put that cellular material in an environment where all metabolic activity stops,” Shelton explained. “And that’s based on temperature.”
When a cell is placed under cryogenic conditions, meaning below -136°C, all metabolic activity ceases.
“That cell-based material is in a state of suspension, meaning that is it neither alive nor dead. And so therefore the cell can arrive at its destination in the same condition that it was shipped,” Shelton said. “You have to put it through a control freeze on the front end and a controlled thaw on the receiving end.”
Keeping a watchful eye over cell-based materials as they travel the globe is extremely important to Cryoport and its partners, Shelton said, because an entire clinical trial could be compromised if anything goes wrong.
“If there’s a temperature excursion for a cellular therapy, then you can compromise the efficacy. If the efficacy is compromised by the temperature rise, the material doesn’t change color, it doesn’t smell, it gives no indication,” he said. “The only indication that one has is that the material has been under controlled conditions all the way along its journey is through the data, and we provide that information that gives our clients the security to know that they are delivering efficacy with their therapies.”
Cryoport may be small, but its presence is widespread. The company now collaborates on 172 clinical trials in the regenerative medicine space and has inked contracts with Novartis and Kite Pharma (NSDQ:KITE), which is now Gilead, to support the distribution and delivery of their products all over the world.
Here is how the process works: At a health center, clinicians draw blood from a patient’s bone marrow. From there, either the patient’s whole blood or just the sample’s T-cells are shipped to a manufacturing plant.
While the product is being shipped to a manufacturing plant, Cryoport is monitoring the package in real-time, collecting data through GPS triangulation. The company monitors conditions inside and outside the package the entire time it is in transit.
After the sample reaches a manufacturing plant and is turned into a cell therapy, Cryoport stores it cryogenically and ships it back to the point of care, where it reaches the patient.
The company is global, with locations in Singapore, California and Amsterdam and plans to soon add three more logistic centers.
Cryoport has shipped all over the world, Shelton noted, helping cell-based materials get to far-flung locales including Liberia, Armenia, Brazil and Myanmar.
The cell therapy space is evolving quickly, Shelton pointed out, and he’s excited to see his company working with the leaders in the field.
“We can’t sit still,” he said. “We are always trying to improve our methodology. We’re always trying to bring down costs. We’re always trying to anticipate the next step in the development of these therapies and what those environments that will be required might be like.
“A lot of folks don’t know exactly what’s coming up here, but I use the analogy sometimes as where the Internet was in 1992. In 1992, it was a glimmer. There was no browser, there was no Internet; today, we’re ubiquitous with the Internet. We depend on it all the time,” Shelton said. “And that’s what’s happening in biopharma. We’re back where the Internet was in 1992 and [cell therapies are] going to change things. It’s going to change the way we look at disease, the way we cure disease.”
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.