What is Cell Processing
Cell processing is the practice of concentrating, selecting and/or culturing cells from blood or blood products, for example bone marrow or cord blood, that can then be used to treat diseases. The process begins with the collection of the blood or blood product (sample) from a person at a hospital or clinic. It is then sent to a processing center or cellular manufacturing facility where the collected sample is processed. The particular process is dependent on the type of therapy the cells are intended to be used for. For example, Hematopoietic Stem Cells (HSCs) are commonly concentrated from cord blood or bone marrow samples and then used to treat various cancers. Cord blood banks are facilities which collect, process and store the stem cell fraction from umbilical cord blood. This is the blood that remains in the placenta and umbilical cord after the baby is born and is a rich source of immune cells. What used to be considered medical waste and discarded by the hospital, can now be used to provide lifesaving cell therapy. Immune cells intended to be used in CAR T-cell therapies, would, in addition to concentration, be selected from the other cells in the population, genetically manipulated and then cultured to increase their numbers (expansion) before therapeutic use. Often times, the cells are expanded to large numbers so multiple doses can be cryogenically stored for later use.
The Stems Cells Found in Cord Blood Can Be Used for Treatment
Cord blood and bone marrow samples are rich sources of stem cells, each containing roughly 0.5% – 1.0% of the mononuclear cell (MNC) fraction. While this number seems very low, it is large in comparison to a much lower percent of MNCs found in the peripheral blood circulating throughout the body. While stem cell therapy is approved for use in hematopoietic stem cell transplantation to treat disorders affecting the blood forming systems, and blood cancers, including lymphoma and leukemia. It can also be used to treat immune system disorders, like Wiscott-Aldrich syndrome, which causes abnormal immune system functions including eczema and a reduced ability to form blood clots. More recently, HSCs are being used in a number of clinical trials to treat some neurological disorders such as cerebral palsy, brain injury, autism, and many others.
Why are Cells Stored?
For many treatments, the cells are used as soon as they have been processed. For example, stem cells concentrated from bone marrow (BMAC or bone marrow aspirate concentrate) can be processed at the point-of-care in a clinic using an automated system such as the PXP System and given right back to the patient (autologous). This procedure, commonly used by orthopedic surgeons, for example, is a form of treatment intended to improve healing by providing stem cells and growth factors directly to the surgical area. But in other instances, the patient receiving the cells is not in the same location or the cells are being banked for future use. In these cases, the cells will need to be cryopreserved to retain their function and viability until they are needed for therapy.
How are Cells Stored?
There are several options for cell storage, but in order for the cells to retain their viability, they must be carefully and properly stored at ultra low temperatures. The cryopreservation process must be performed at a specific cooling rate, usually 1°C/minute, until the sample reaches -50°C in order to preserve the sample’s integrity during the freezing cycle. Once the sample reaches -50°C it can be quickly brought to the final storage temperature of -196°C for long term storage. Controlled rate freezing before storage maximizes viability for a wide variety of cells.
Red Blood Cells Contamination
Red blood cell contamination can be a critical issue medical professionals encounter during cell processing. When high RBC contamination occurs, it can impair cell function and diminish the overall effectiveness of cell treatments. In order for cells to be at their most viable, red blood cells must be removed. The presence of red blood cells can be dangerous for a couple of reasons.
The presence of red blood cells may cause patients to have an adverse reaction during transplantation. In addition, these cells undergo what is called lysis during cryopreservation. That is, a rupture of the cell membrane that spills the cell’s contents, causing patients to feel sick.
How Automated Cell Processing Can Combat Red Blood Cell Contamination
Cell therapy is growing and it is becoming the future of regenerative medicine. However, many people don’t understand the processing methods behind it.
Cell processing is not equal across the industry and while some processing facilities utilize manual processing methods, we believe in the benefits of using highly sophisticated, automated processing systems such as the PXP and PXP-1000 Systems.
Automated cell processing can reduce the risk of RBC contamination, increase efficiency, decrease costs, and most importantly, improve the safety and effectiveness of future cell treatments.
The PXP and PXP-1000 Systems utilize bone marrow and cord blood, respectively, collected from patients. The patient’s sample is placed into a single use disposable cartridge and then centrifuged. During this 2-step process, the cellular components are first stratified, i.e., layered into separate levels, within the cartridge. In the second step of processing, the layers are automatically delivered into separate compartments. At the end of the process, the plasma, red blood cells (RBCs) and the buffy coat (White Blood Cells or WBC), are each delivered in separate compartments of the cartridge and are available for use.
The PXP and PXP-1000 Systems are automated, closed systems designed to meet Good Manufacturing Practice (GMP) requirements. This state-of-the-art technology provides scientists and medical professionals with peace of mind, knowing that they are saving the highest quality cells with which they can treat their patients.
ThermoGenesis Offers Automated Solutions to Help Mitigate RBC Contamination
The PXP and PXP-1000 Systems are cell processing solutions designed with the cell therapy industry in mind. Our team of experts at ThermoGenesis recognize that physicians performing cell therapies need a system that can produce a very low hematocrit product with minimal granulocytes for immediate use. We offer this and other products that are developed with the needs of laboratories and physicians in mind, giving them the tools they need to better treat their patients.
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. We are committed to making the world a healthier place by creating innovative solutions for those in need.
For more information on the PXP and PXP-1000 Systems, please contact us.