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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).
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.
Adaptimmune is a biopharmaceutical company that develops T cell therapies against cancer. The company was founded in 2008 in the UK with links to both Oxford University and the University of Pennsylvania. It has headquarters in Philadelphia and Milton Park. [1]
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 (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 ...
Advanced Therapy Medicinal Products, or ATMPs, are advanced therapeutic drugs that are based on cell therapy or gene therapy (sometimes in combination with a medical device - where they are then called a tissue engineered product).
Idecabtagene vicleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. [ 4 ] [ 7 ] Each dose is customized using a patient's own T-cells, which are a type of white blood cell, that are collected and genetically modified to include a new gene that facilitates ...
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 ...