Cell therapy is a promising and rapidly growing field which offers hope for novel treatments in a wide range of areas, from the regeneration of diseased tissues or organs, to fighting cancer using specialized immune cells. Many different types of cells are under investigation for cell therapy and can be harvested from both autologous and allogeneic sources. Each cell type presents its own unique challenges and requires specialized harvesting, banking, expansion and processing protocols for preparing living cells of sufficient quality to be used in humans as regulated therapeutics. Cell therapy products require exceptional quality control and procedures to maintain integrity and functionality from cell collection through to patient administration. Researchers and manufacturers must have confidence their valuable cells have not been mishandled or exposed to damaging warming events. From cell collection, processing, cryopreservation to therapeutic administration, Brooks Life Sciences offers flexible, standardized and easy-to-use systems for all the critical temperature-controlled steps in cell therapy workflow.
Cell Therapy Pathway
During the collection of biological samples from the donor, there are several steps that require controlled holding times at specified temperatures, whether in process or during product transfers. Brooks offers a range of products that assist in the collection and preservation of these samples. The CoolRack® modules hold sample tubes at the required temperature and are easily integrated into the CoolBox™ XT workstation facilitating ice-free transport and processing of cells. Biopsies can be snap frozen in liquid nitrogen and this method can be standardized with the adoption of the ThermalTray™ platform and 9 liter TruCool® ice pan filled with LN2. Afterwards transport samples using the CryoPod™ Carrier to secure storage in BioStore™ III Cryo System. Frequently it is imperative to cryopreserve back-up samples of the biological specimen/starting cell population and this can easily be achieved using the CoolCell® cell freezing containers which provide controlled-rate freezing when placed at -80°C.
During cell therapy manufacturing, all steps need to be performed in a cGMP environment. The cells of interest are isolated and may be reprogrammed via transduction, and are cultured or expanded to the required therapeutic volume. Cellular therapeutic products are then transferred to final containers via fill/finish procedures. Short transfer steps may be needed and strict temperature standards need to be maintained to ensure functionality of the cells.
One critical step which is almost universal to cell therapy procedures is the biopreservation of the live cells, whether for short-term storage under temperature-controlled conditions, or long-term cryopreservation with the necessity to maintain both viability and the critical biological function that make these cells therapeutic. The CoolCell® cell freezing containers provide a controlled -1℃/minute freeze rate when placed in a -80℃ freezer without the need for alcohol or expensive, dedicated equipment such as controlled-rate freezers.
Post-cryopreservation, its essential to store the cells in a freezer at -80°C or ideally lower, Brooks provides the BioStore™ III Cryo System solution as a best-in-class automated -190°C sample management. To ensure temperature stability for valuable cell therapies during transport to and from the storage units, frozen samples should be transported in a CryoPod™ Carrier to ensure transient warming events are eliminated.
Shipment of the frozen samples in an LN2 dry shipper to final destination. The CryoPod™ Carrier enables -150°C sample transportation over short distances and the BioStore™ III Cryo System provides a cryogenic biological storage solution at the clinic that combines the highest sample protection, improved chain of custody management, and a superior user experience. At the clinic/hospital, frozen cells are received and thawed in a controlled manner. They may be washed to removed the cryoprotective media or go through further QA, prior to patient administration. Tracking of cell therapeutic is essential and can easily be achieved with the FluidX Scope™ Single Sample Tube Reader for 1D and 2D barcodes.