Creating something that doesn’t exist, especially if it solves a real-world problem, will put a business on the map. However, having the ability to adapt to the needs of the industry and respond to changes in real time is what will ensure that the business is sustainable. In other words, innovation gets you in the door, but adaptability is what keeps you in the house. For more than three decades, ThermoGenesis Holdings Inc. has proven its ability to remain flexible and adaptable, while staying focused on the overarching mission that led to its creation.
Originally an engineering design company, ThermoGenesis was founded in 1986 with the name Instacool Inc. Founder Philip Coelho had the idea to create a product that would chill beverages almost instantly. Instacool products were placed outside of Pack-N-Save stores where customers leaving the store could pay a quarter to have their sodas, juices, and other bottled beverages cooled by 40 degrees in 60 seconds. As successful as the original product was between 1987 – 1989, it didn’t come without some drawbacks ranging from over creative customers who attempted to “chill” lettuce to those who experimented with the freezing capacity of various beverages and their containers.
It wasn’t until around 1990 that Coelho realized this product could be used to solve a global problem and decided to transition into the field of medicine.
Responding to a Global Crisis
On a drive from Augusta to Atlanta, Coelho heard a radio interview where Tom Asher was explaining how patients with hemophilia were contracting AIDS from the Factor 8 blood protein that they received from donor blood infected with the AIDS virus. Doctors and scientists at the time had discovered that they could kill the AIDS virus in the blood by heating the plasma, but that process would simultaneously kill the Factor 8 yield needed for hemophiliacs. One way to solve this problem, according to Asher, was to freeze the plasma very fast. Hearing this, Coelho pulled his car over to the nearest phone booth (remember, this was the early 90s and cell phones did not exist), called Asher and explained that he had a way to solve this problem.
First FDA Approval
ThermoGenesis received its first FDA approval for an ultra-rapid blood plasma freezer and thawer product line. The first of its kind, this product line was sold to blood banks worldwide.
A Test in Adaptability
Realizing that the coolant used in the product line could impact the environment, the company now needed to find a new liquid that would provide the same freezing time. Coelho decided to start using a silicone with a low freezing point and created the system that is now the modern-day Thermoline. This was the first in a series of opportunities for the company to respond to the needs of the industry, and create products that adapt to the ever-evolving field of medicine.
A Mission to Save Lives
Bone marrow transplants can be life-saving procedures, but are limited to the ability to locate an eligible donor. Pablo Rubenstein, the father of cord blood banking, set out to solve this problem by finding an alternate treatment for patients who needed a transplant. He was looking for a moderate-sized company to partner with for his investigation into cord blood cells and their viability as an alternative to bone marrow.
After learning about the success of ThermoGenesis, he partnered with the company to co-develop the Cord Blood Transfer/Freezing Bag Set, which allowed donor blood cells to be concentrated into a small volume and securely frozen (cryopreserved) so they could be readily available for patients needing a transplant. This new blood bag provided a “closed” processing procedure that, unlike previous open processing procedures, was safe and storage efficient. While the issue of safety was mitigated with the introduction of the manual Transfer/Freezing Bag Sets, the process was manual and time consuming. This provided another opportunity for the company to adapt, assess the needs of this field, and respond with the creation of a new, more efficient system.
The Automated Storage System for Cord Blood Banking
Once cells are retrieved, they’re kept frozen and stored within liquid nitrogen. This cryopreservation is what “stops time” and improves cell viability for the future. However, once the cells experience a temperature change and begin to thaw, in what’s known as a transient warming event (TWE), they begin to change. The BioArchive® System was created as a means of automating cord blood storage and retrieval to reduce TWEs and maintain cell viability. The system yields a cell viability of 94 percent post-thaw (when used in conjunction with the AXP® System), making it a highly effective method of cryopreservation and storage. To date, there are more than 300 BioArchive Systems used globally.
The field of medicine is constantly changing, and ThermoGenesis is determined to adapt along with it. With that in mind, there was still more to be done to improve the practice of processing cells, and this led to a major milestone not just for the company, but for the field of medicine.
A Major Industry Milestone – Automation of Cell Processing
To resolve the next greatest drawback to cord blood processing, that being the quality and time needed for processing, Thermogenesis developed what is now known as the AXP® System. The first automated closed cord blood processing system to receive 510 (k) premarket clearance by the FDA, its introduction provided the ability to recover 97 percent of donor cells with a 99.9 percent viability post-thaw, a near-perfect result.
Expanding Into New Fields
For the majority of its existence, the field of regenerative medicine has required the use of donor cells. Most recently, however, a new field has emerged, which requires no more than the cells from the patient’s own body and the technology with which to process them.
Under the leadership of CEO, Dr. Chris Xu, ThermoGenesis began developing a suite of products to help meet the needs of the emerging and promising new field of cell and gene therapy. This therapy is a process that modifies the expression of a gene or alters the biological process of living cells for therapeutic use. In essence, a patient’s cells are retrieved, genetically modified, then introduced back into their body to fight a disease. Ideally, a patient could have their blood extracted and cryopreserved when they’re perfectly healthy, and through immune cell banking, have it ready for use should they fall ill in the future.
A Costly Procedure
Currently, there are five gene therapies approved by the FDA, each costing upwards of $300,000 per dose. For example CAR T-cell treatment, though proven to be effective, is not covered by many insurance providers, creating an accessibility barrier for the millions of patients who could benefit from it. The mission of ThermoGenesis is to increase patient accessibility to these life-saving therapies by reducing manufacturing costs. As such, the leadership of the company believes that there is still much work to be done.
The Future of ThermoGenesis
The future of regenerative medicine is cell and gene therapy, and the leadership of ThermoGenesis believes that the greatest role they will play is the one they’ve had the most experience and success in — manufacturing. Ideally, clinics and hospitals will have the ability to give patients access to therapeutic procedures on-site, in one visit, and at an affordable cost.
ThermoGenesis Holdings Inc., is a pioneer and market leader in the development and commercialization of automated cell processing technologies for the cell and gene therapy fields. We market a full suite of solutions for automated clinical biobanking, point-of-care applications and large-scale cell processing and manufacturing with a special emphasis on the emerging CAR-T immunotherapy market. We are committed to making the world a healthier place by creating innovative solutions for those in need.
For more information on our entire suite of automated solutions, please contact our sales team.