Contract Development Manufacturing Organization (CDMO) partnerships are on the rise due to an increased demand for cell therapies and the limited availability of Good Manufacturing Practice (GMP) approved manufacturing facilities and other resources. Pharmaceutical & biotechnology companies are needing to outsource their product development and manufacturing in order to try to meet these demands, even going as far as working with end-to-end CDMO partners to maximize efficiency, minimize risks and reduce costs. These efforts are intended to make life-saving therapies like CAR-T available to as many patients as possible.
Introduction to the Cell Therapy Manufacturing Process
Cell and gene therapy (CGT) are overlapping fields of treatment. Whether autologous (patient derived) or allogeneic (donor derived), they both begin with the collection of cells from a patient. The cells may then be processed in various ways, i.e., enrichment, selection, expansion, differentiation, or cryopreservation, before they are ultimately provided to the patient. Each of these steps utilize various buffers, media, growth factors, cryoprotectants, etc., and procedures that may impact therapeutic potential. For example, the transfusion of cryopreserved blood products has been associated with adverse clinical outcomes, brought on by factors such as free hemoglobin, excess potassium, and other contaminants that are added or that accumulate during cell storage. To avoid these outcomes, volume reduction or “washing” is performed to remove harmful contaminants prior to patient transfusion. This is an essential step in the safety and efficacy of cell and gene therapeutics. Cell washing ensures a greater cell purification, making the cell therapy for which they are intended that much more safe and effective.
Benefits of Automated Cell Processing for GMP Cell Therapy
Good Manufacturing Practice is a quality assurance practice which is used across a range of industries, including medical manufacturing of human drug and biologic products. The intent of GMP is to ensure that pharmaceutical products have consistent strength, purity, safety and quality. GMP guidelines provide quality assurance for all aspects of manufacturing, from equipment and staff training to operational processes and storage conditions. This leads to greater effectiveness, consistent lot-to-lot production, standardization and the reduction of risks associated with the final products that patients receive. The automated cell processing provided by standardized devices such as the PXP®-LAVARE System are GMP compliant, giving peace of mind that the cell therapy provided to patients is of the highest purity and quality.
Cryopreservation and CGT CDMO
Cryopreservation preserves cells and tissues by freezing samples to very low temperatures over a period of time and is key to maintain long-term cell viability and efficacy of cell therapeutics. It helps to reduce the exposure to transient warming events (TWE) which can negatively affect the viability and functionality of cells, especially if they are to be used for cell therapeutics at a different time.. Cell therapy products pose the unique logistical challenge of maintaining living cells in a viable state from collection to storage to distribution, which is kept track of through cold chain management. The selection of the appropriate storage technology, then, is another important aspect of cell and gene therapy manufacturing.
BioArchive is an Automated CGT CDMO Solution
ThermoGenesis’ BioArchive System is a fully-automated, closed-system cryopreservation platform that provides the only 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 current FDA guidelines. What makes this system stand out from others in the industry is that it is an all-in-one, cryopreservation platform, that fulfills GMP requirements and has been and is currently an attractive storage solution for the world’s leading public cord blood banks.
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