GMP Grade Cell Isolation and Activation

GenScript offers the Enceed™ T Cell Activation Reagents and the CytoSinct™ Cell Isolation Platform, featuring both Nanobeads and Instruments. These solutions deliver outstanding performance, fast delivery, reliable supply, and cost-effectiveness—empowering safe, stable, and rapid development of cell therapies.

: Leading GMP Facility

: Global Compliant GMP System

: 100% Passed Audits

: Supported 30+ Clinical Studies and IND Applications Globally

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Spanning approximately 2,000 square meters, GenScript’s cGMP manufacturing facility is purpose-built to meet the stringent requirements of major global regulatory agencies, including the U.S. FDA, EMA, PMDA, and NMPA. The facility operates under a comprehensive GMP quality management system that encompasses raw materials, equipment and facilities, laboratory controls, production, packaging, and labeling. Equipped with advanced technologies and compliant cleanrooms, the plant follows standardized production processes and a robust sterility assurance system. GenScript offers end-to-end services to support preclinical, clinical, and commercial-stage programs—delivering high-quality, sterile products that meet global registration and manufacturing standards.

Clinical Cases

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.

Ucello Biotechnology

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.