A key element of all cell and gene therapies (CGTs) is cryopreservation, the controlled freezing of cell samples. In cell therapy manufacturing, cell samples are collected and stored for future use, often for decades, so the proper collection, cryopreservation and retrieval of these samples is essential for safe and effective CGTs. In addition, it’s also important for cell samples to be traceable during the vein-to-vein cycle to ensure the safety of patients receiving treatments. Especially in allogeneic (patient-derived) therapies, it’s essential to track cell samples through the manufacturing process to ensure patients are getting the samples that are intended for them. Choosing the right system for cell storage is, therefore, an extremely important decision. The BioArchive System offers a complete solution, with automated cryopreservation, retrieval, and traceability throughout the cell manufacturing process.
The Importance of Proper Cryopreservation and Storage for Cell Viability in the Cell Therapy Manufacturing Process
There are a number of reasons why proper cryopreservation of cell samples is important for cell viability. To start, the cell manufacturing process often takes place in more than one location, which creates unique logistical challenges for this field, including just finding a manufacturing facility that meets Good Manufacturing Practices (GMP) standards. Scientists and medical professionals need to be able to safely collect and transport samples to their final destination, whether that is to be delivered to the patient, or stored for future use, as is normally the case.
Challenges in Cell Therapy Manufacturing
The cell and gene therapy process has many steps, ranging from process development to fill and finish. Cells are collected from the patient, then transferred to the manufacturing site for genetic modification and production. The cell therapy is then shipped back for patient treatment. Throughout the shipment process, the material must be under very specific conditions – cryopreserved under liquid nitrogen – in a very short period of time. Liquid nitrogen is an effective, long-term method for storing cell samples. This transfer of therapy requires a strict temperature chain and monitoring under GMP standards to ensure its safety and effectiveness for patient administration, and reduce risks.
BioArchive Offers a GMP Approved Cell Therapy CDMO Solution
ThermoGenesis’ BioArchive System is a fully-automated, closed-system that provides a complete cryopreservation, storage, retrieval and tracking solution for the entire cell therapy manufacturing process. Cell samples are robotically cryopreserved and stored with integrated software for traceability. In addition, samples are maintained under a consistent temperature, which makes the system meet and exceed FDA guidelines. What makes this system stand out from others in the industry is the fact that it has so many capabilities, which makes for a more time and cost effective cryopreservation and storage solution that is currently used by the world’s leading public cord blood banks.
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