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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.
Prescient Therapeutics Ltd (Prescient) was created in 2014 by bringing together two small molecule drug assets from separate US private companies (Pathway Oncology for PTX-100 and AKTivate Therapeutics for PTX-200) into the existing ASX-listed shell company Virax Holdings Ltd (Virax).
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 ...
A major application of cellular adoptive therapy is cancer treatment, as the immune system plays a vital role in the development and growth of cancer. [1] The primary types of cellular adoptive immunotherapies are T cell therapies. Other therapies include CAR-T therapy, CAR-NK therapy, macrophage-based immunotherapy and dendritic cell therapy.
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 ...
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.
Biomanufacturing products are recovered from natural sources, such as blood, or from cultures of microbes, animal cells, or plant cells grown in specialized equipment. The cells used during the production may have been naturally occurring or derived using genetic engineering techniques. [citation needed]
A regenerative medicine therapy is defined in section 506(g)(8) of the FD&C Act to include cell therapies, therapeutic tissue engineering, human cell and tissue products. Under the FDA's interpretation, gene therapies and genetically modified cells that have a lasting effect, such as CAR-T antitumor therapies, may also qualify as regenerative ...