CytoSinct™ 1000

On January 11, 2025, Ucello Biotechnology Co., Ltd. announced that its independently developed umbilical cord blood derived allogeneic CD19-targeted CAR-T cell product, UC101, received Investigational New Drug (IND) application approval from the U.S. Food and Drug Administration (FDA). This is the first FDA IND approval of an umbilical cord blood derived allogeneic CAR T cell therapy program.

GenScript provided the essential raw materials, including Enceed™ T cell Activation Reagent, CytoSinct™ Cell Isolation Nanobeads (GMP) for various targets, and the CytoSinct™ 1000 instrument. The pre-conjugated, nanoparticle mediated cell isolation and activation technology, along with comprehensive global regulatory support provided by GenScript were crucial in achieving this milestone, making CAR-T cell therapy more accessible to broader range of patients.

On November 14, 2024, Base Therapeutics Co., Ltd. announced that its independently developed, world-first base-edited universal NK cell product, NK510 Cell Injection, received Investigational New Drug (IND) application approval from the U.S. Food and Drug Administration (FDA) for the clinical treatment of advanced solid tumors. On October 22, NK510 Cell Injection received the IND approval form NMPA.

GenScript is proud to have supported the development of this groundbreaking therapy with our CytoSinct™ Cell Isolation Nanobeads (GMP) and CytoSinct™ 1000 instrument. The CytoSinct™ platform has completed FDA DMF activation, underscoring its readiness for clinical applications.