Asymptote’s digitally-enabled cryogenic cold chain technology supports safe manufacture and delivery of cellular therapies
Cellular therapies are rapidly changing healthcare with life-saving treatments for many of the world’s most challenging diseases, such as cancer.
In cellular immunotherapy, it starts when the patient’s cells are harvested from the blood, frozen and shipped to a lab, where they are thawed, modified and then cultured. Then they’re frozen below -132˚ C (-200˚ F) and shipped back to the patient’s location, where they are thawed and injected into the bloodstream to attack unwanted cells like leukemia.
Not surprisingly, the market for cell therapy is expected to explode over the next decade. The cell therapy oncology market alone is expected to reach $30 billion by 2030, and almost 800 potentially life-changing therapies were in clinical trials at the end of 2016.
But what happens to the cells during the freezing, shipping and thawing process is extremely important, as it is necessary to safeguard cells in the right way, assuring their preservation, while following strict regulatory requirements before they are given to patients. Asymptote is a Cambridge, England-based company that has developed this freezing process, creating exceptional cryogenic technology for cell therapies.
“Freezing cells allows these clinical procedures to occur,” says Dr. John Morris, founder and CEO of Asymptote. “You’ve got to be able to freeze the cells so you can manage scheduling, quality, patient ownership, assure that they aren’t contaminated, and then safely transport them back to the patient.”
As part of its commitment to cell therapy, GE Healthcare announced on April 11 that it has acquired Asymptote LTD.
“Asymptote’s high-quality offering takes us another step forward in our vision to industrialize cell therapy,” says Ger Brophy, General Manager of GE Healthcare’s Cell Therapy business. “We want to improve the access to cellular therapies and tap the great potential that they have in curing some of our most difficult diseases.”
From ice cream to cell therapy
Asymptote specializes in innovative technologies that maintain the potency of cellular therapies through ultra-low temperature freezing during production, all the way to thawing at the clinic prior to administering to patients.
They currently offer two kinds of products for both ends of the cold chain of these sensitive cellular therapies: freezers that cool cells from room temperature to below -150˚ C (-238˚ F) and thawing devices that gently warm up cells to be safely reinjected into a patient’s body.
“Our technology controls critical stages in the whole cryopreservation process from freezing cells in a controlled manner without the need of liquid nitrogen to thawing in dry conditions,” says Dr. Morris. “Our products offer a completely different option from what is done in conventional practice.”
The company also offers a web-based platform that tracks the cells throughout the process. “Our customers can send specific freeze or thaw instructions from any web-browser and view what is happening in the equipment wherever it is in the world,” he says. “It makes the whole thing more 21st century.”
Dr. Morris started Asymptote in 1989 after getting his PhD in cell cryogenics. The company worked on freezing all kinds of products in many industries, from ice cream and frozen cocktails to petrochemical work and pharmaceutical products.
Then cell therapies hit the market.
“About seven years ago, we realized that cells have to be frozen in a better and different way,” he says. “Cryopreservation was a big bottleneck for the clinical delivery of cells.”
Asymptote contributed to this industry by developing a freezing process without liquid nitrogen, one of the most commonly used cryogenic fluids. Liquid nitrogen poses many challenges for medically sensitive processes because it’s not sterile, which could expose the cells to bacteria or viruses.
Dr. Morris and his team pioneered the use of Stirling cryocoolers, which were invented about 200 years ago in Scotland, to cool the cells and keep them uniformly cold during transportation and storage – a critical step in making sure every patient gets reliable, quality-controlled cell therapies.
“To get good cell viability, you have to do a very controlled, slow freeze,” he says. “Stirling engines give us an incredibly accurate way of doing that and allows high uniformity. If you freeze 200 samples at a time, all the samples freeze exactly the same.”
Expanding therapy’s reach with cryopreservation
Dr. Morris says that Asymptote and GE Healthcare share a passion for cell therapy. “GE Healthcare has a very vibrant regenerative medicine division that has a great outreach,” says Dr. Morris. “Now we can get our products out to a lot of customers so they can be used by more people”.
Asymptote continues to pioneer advancements in cryocooling cell therapies, with a focus on freezing larger volumes of cells, types of cells that are difficult to freeze, and larger cells. “We’re pushing the boundaries of what can be frozen, and this is a very exciting medical area” he says.
It’s all part of a bigger push to improve healthcare for millions of people around the world.
“Patients are treated with cell therapy on a one-off basis and then, in an ideal world, they’re cured of the problem,” he says. “Some of these diseases have hundreds of thousands of patients per year, and cell therapy is relatively cost-effective because patients don’t need to keep taking monthly or daily medication. It’s a completely different model than what happens in standard pharmaceutical treatments and diseases. It has the potential of transforming healthcare.”