Advanced Cell & Gene Therapy Center

About the Clinical Manufacturing Support Department

Advanced regenerative medicine covers therapies that treat or prevent disease, or address defects in body structure and function that affect a patient's life and health. From high-risk to medium- and low-risk therapies, these treatments are delivered through clinical research involving diverse approaches such as modifying or culturing cells.

The Clinical Manufacturing Support Department of the Advanced Cell & Gene Therapy Center is a cell processing facility that provides comprehensive support for human cells, etc. (advanced biopharmaceuticals) used in advanced regenerative medicine clinical research. It supports every step of producing human cells, etc. for clinical research, from process development through quality assurance.

Advanced Biopharmaceutical Manufacturing Facility

Aseptic Processing Room 1

Area for cell therapy product manufacturing, centered on adherent culture equipment

Aseptic Processing Room 2

Area for cell & gene therapy product manufacturing, centered on adherent and suspension culture equipment (Cytiva equipment)

Aseptic Processing Room 3

Area for cell & gene therapy product manufacturing, centered on suspension culture equipment (Miltenyi Biotec equipment)

Key Infrastructure

Research Support Services

Support for Advanced Regenerative Medicine Clinical Research

• · Process development support for clinical research
• · Production support for human cells, etc. for clinical research
• · Quality testing support for human cells, etc. for clinical research
  1. Sterility testing
  2. Endotoxin testing
  3. Mycoplasma negative testing
  4. Replication-competent virus negative testing
  5. Total cell count testing
  6. Insoluble particulate matter testing

Support for Advanced Regenerative Medicine Treatment

• · Production and quality testing support for human cells, etc. used in advanced regenerative medicine treatment

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