REPROCELL Japan GMP Facility

GMP Facility for Manufacturing Cell-based Products

Our manufacturing center holds an MHLW license for the production of specified processed cell products (Facility No. FA3200006) under Japan’s Act on the Safety of Regenerative Medicine. This license requires compliance with strict quality, safety, and operational standards. Under this license, we are authorized to perform contract manufacturing of cells for clinical research, all within a fully audited and controlled quality management system

Facility Environment & Rigorous Quality Control

The facility includes multiple cleanrooms with graded air‐cleanliness levels, pressure-controlled zoning, and unidirectional personnel and materials flow to minimize contamination risk. All cell processing is performed in aseptic biological safety cabinets. Environmental controls are continuously monitored (temperature, pressure, and airborne particulates) with real-time deviation alerts. In addition, routine environmental monitoring of airborne, settling, and surface microbial loads is conducted across all classified areas.

Key Manufacturing Experience

Our center has a proven track record in the manufacturing of:

• REPROCELL's iPSC-derived Exosomes
  
• StemRNA Clinical iPSC Clones
• TIL (Tumor-Infiltrating Lymphocytes) for clinical research