This article identifies four key processing technologies that are utilized by cord blood banks worldwide and the companies responsible for developing each one. Automated processing systems have many benefits, including speed, processing efficiency, and cost-savings. However, automated processing systems have not always dominated the cord blood banking industry.
Introduction to Automated Cord Blood Processing
In 2006, the AutoXpress® System was launched by Thermogenesis, a company which then merged with TotipotentRX Corporation in February 2014 to create Cesca Therapeutics.
The AutoXpress® (AXP®) technology was the first automated, functionally closed, sterile system to obtain stem cells from cord blood through an efficient and high yield process, allowing for the automated processing of cord blood samples. The AXP® Platform brought unprecedented automation and precision to cord blood stem cell processing. By 2007, Cord Blood Registry, the world’s largest private cord blood bank, had fully incorporated the AXP® platform into its cord blood operations, showing the willingness of the company management to invest in new processing technology.
Automated processing systems efficiently recover mononuclear cells (MNC) in cord blood collections. One of the other major benefits to automated processing systems is found in the replaced need for additives and human manipulation.
As the first automated processing technology to enter the cord blood market, the AXP® Platform uses optical sensor technology to formulate precision separation and retention of almost all the target mononuclear cell population. When this process is automated, there is a reduced chance of contamination and an increased reliability of results.
Four Market Leaders in Automated Cord Blood Processing
There are now four key processing technologies operating within the cord blood banking market that allow for automation of the traditional process of manual cord blood processing, each with distinct advantages and disadvantages, as described below.
1. AutoXpress® Platform (“AXP®”) and BioArchive System (By Cesca Therapeutics in Rancho Cordova, California, USA)
As mentioned, in 2006, the AutoXpress® System was launched by Thermogenesis, a company that was acquired by Cesca Therapeutics in February of 2014. It was announced as the first automated, functionally closed, sterile system to obtain stem cells from cord blood through an efficient and high yield process.
The system can reduce a unit of cord blood to an exact volume selected by an individual processer, using a closed processing set and individual collection bags for buffy coat, plasma, and red blood cells. Together, the system reliably collects all fractions. One of the key benefits of the AXP® Platform is the high success rate of cell yield, an important metric because transplant survival rates improve when higher numbers of stem cells are used in cell therapy.
In addition, the system enables the tracking of data for each unit of cord blood processed. An advantage of the AXP® platform is that cord blood units processed with AXP® are richer in mono nuclear cells (MNC) than units processed by traditional means, and the CD34+ stem cell recovery is greater than 97%. The system also has an in-line clot filter and multiple sampling ports to ensure quality results.
Shortly after launch of the AXP® technology, the world’s largest private cord blood bank by total units stored, Cord Blood Registry, incorporated the AXP® platform into its business operations. In addition to serving the private cord blood sector, the technology has entered the public cord blood banking sector. The National Cord Blood Program of the New York Blood Center (NYBC), the largest public cord blood bank in the world, has also adopted AXP® processing.
Since its inception, the National Cord Blood Program has publicly stored over 60,000 cord blood units. In December 2013, ThermoGenesis Corp. also entered into a major deal with Bebevida, a cord blood stem cell bank in Portugal, to provide the AXP® AutoXpress® System for their service, a contract which allowed them to replace a competitor’s automated processing system and expand the reach of the AXP® system within Europe.
2. Sepax (By Biosafe in Eysins, Switzerland)
The Sepax system, similar to the AXP® system, is a fully-automated system that allows for efficient processing of umbilical cord blood, in a bag processing set, through centrifugation and the eventual separation into different components.
The Sepax system separates cellular components by utilizing a light beam to identify the density gradient between various cell layers, after cellular separation has been achieved through centrifugation of the full blood sample. The system uses a rotating syringe technology that provides both separation and component transfer through displacement of the syringe piston. The bag system is a single-use, sterile, fully-closed system.
Compared to the AXP® platform, the Sepax system generates a substantially better total nucleated cell (TNC) recovery. It also has strong CD34+ cell recovery after cord blood unit volume reduction and is efficient in red blood cell depletion.
One of the most commonly used automated processing systems within the cord blood industry, the Sepax system is used by many market leaders, including Cryo-Save, the largest private cord blood storage operator in Europe with samples stored from over 70 countries, across six continents. Cryo-Save also has processing and storage facilities in Belgium, Germany, Dubai, India, and South Africa, making this a large and important contract for BioSafe.
3. PrepaCyte®-CB (By Cryo-Cell International, Oldsmar, Florida, USA)
The PrepaCyte®-CB system is a sterile, three-bag, closed system which is used to separate and obtain Total Nucleated Cells (TNC) including CD34+ stem cells and other stem cells from cord blood. It is manufactured in accordance with current Good Manufacturing Practices (cGMA) regulations of the United States FDA. It is a simple system that allows for greater uniformity in processing.
This system of cord blood processing has the ability to provide greater yields of clinically relevant cells, most importantly stem cells, by removing approximately 99% of all unnecessary red blood cells from the final processed cord blood unit. It also minimizes risks of contamination during processing.
At the 15th Annual International Cord Blood Symposium in San Diego, California, in June 2017, the St. Louis Cord Blood Bank presented the median time it took patients infused with cord blood using either its Hetastarch or PrepaCyte-CB processing method to reach an absolute neutrophil count (ANC) of 500. PrepaCyte-CB was found to engraft a full four days more quickly than the Hetastarch processing method (16 days versus 20 days) and has shown to be just as safe to the patient. Combining this data with those of other public data sources, PrepaCyte-CB was found to engraft more quickly than any other processing method.
Cryo-Cell International is the only private bank in the U.S. to offer the PrepaCyte-CB cord blood banking technology. As part of the assurance Cryo-Cell has on the PrepaCyte-CB–processing method, it offers its clients a $100,000 guarantee that the cord blood will engraft if used in a transplant.
4. Cord Blood 2.0TM (By Americord in New York, NY, USA)
Compared to traditional cord blood stem cell collections systems, the Cord Blood 2.0 TM can obtain substantially greater quantities of stem cells for preservation. The main advantage that results is that the cord blood units can be used for hematopoietic stem cell transplant in patients who are larger in size. Historically, the volume of stem cells preserved during traditional processing of a cord blood unit has only been sufficient to allow for the treatment of patients up to 60-70 pounds.
The Cord Blood 2.0TM process is a two-step process. The first step uses gravitational force to collect a large volume of cord blood from the umbilical cord and placenta following a live birth. In the second step, the collected cord blood is processed at the Americord laboratory. The proprietary process allows for higher volumes of stem cells to be extracted compared to other currently available methods. It is not known yet if Americord will sub-license this automated cord blood banking system to other cord blood banking operators.
To learn more, view the “Complete 2017-18 Global Cord Blood Banking Industry Report.”
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