Authors: Fraser, Henrieta, Safinia, Niloufar, Grageda, Nathali, Thirkell, Sarah, Lowe, Katie, Fry, Laura J., Scottá, Cristiano, Hope, Andrew, Fisher, Christopher, Hilton, Rachel, Game, David, Harden, Paul, Bushell, Wood, Kathryn, Lechler, Robert I., Lombardi, Giovanna
Venue: Molecular Therapy - Methods & Clinical Development
Type: Publication
Abstract: The concept of regulatory T cell (Treg)-based immunotherapy has enormous potential for facilitating tolerance in autoimmunity and transplantation. Clinical translation of Treg cell therapy requires production processes that satisfy the rigors of Good Manufacturing Practice (GMP) standards. In this regard, we report our findings on the implementation of a robust GMP compliant process for the ex vivo expansion of clinical grade Tregs, demonstrating the feasibility of this developed process for the manufacture of a final product for clinical appli...
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