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Distributed manufacturing (DM) is a production model that decentralizes manufacturing processes, enabling products to be designed, produced, and distributed closer to end-users. This shift from centralized production to localized networks offers advantages such as increased flexibility, cost efficiency, and local empowerment.
Diagram from the National Cancer Institute (NCI) depicting the classical method of constructing a CAR-T cell for therapy. Production of CAR-T cells involve removal of T cells via an extraction process known as leukapheresis , followed by cell culture with viral vectors containing ingredients needed to construct the chimeric system.
Cell therapy bioprocessing is a discipline that bridges the fields of cell therapy and bioprocessing (i.e., biopharmaceutical manufacturing), and is a sub-field of bioprocess engineering. The goals of cell therapy bioprocessing are to establish reproducible and robust manufacturing processes for the production of therapeutic cells.
Depiction of adoptive cell transfer therapy with CAR-engineered T cells. The first step in the production of CAR T-cells is the isolation of T cells from human blood. CAR T-cells may be manufactured either from the patient's own blood, known as an autologous treatment, or from the blood of a healthy donor, known as an allogeneic treatment. The ...
Cellular manufacturing is a process of manufacturing which is a subsection of just-in-time manufacturing and lean manufacturing encompassing group technology. The goal of cellular manufacturing is to move as quickly as possible, make a wide variety of similar products, while making as little waste as possible.
The accompanying diagram is a general model which shows functional manufacturing levels using computerised control. Referring to the diagram; Level 0 contains the field devices such as flow and temperature sensors, and final control elements, such as control valves
Cell therapy (also called cellular therapy, cell transplantation, or cytotherapy) is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect, [1] for example, by transplanting T-cells capable of fighting cancer cells via cell-mediated immunity in the course of immunotherapy, or ...
Axicabtagene ciloleucel (KTE-C19, ZUMA-3, YESCARTA) was an investigational therapy (for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)) in which a patient's T cells were genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. [11]