FACILITY AND EQUIPMENT

Facility

About Our Facility
Facility area 3300 m2
Compliant PIC/S GMP
Manufacturing service
  • CAR-T cell manufacturing
  • Viral vector manufacturing (including Lentiviral vector, LVV)
p.s. two areas are physically separated
Product grade
  • GMP grade
  • Clinical trial grade
  • R&D/PD grade
Supporting document CMC-related document for IND/NDA
GMP document

Equipment & Instruments

All the electronic data managements of equipment or instruments are compliant with US FDA 21CFR Part11 to ensure the data is true and protect customers’ data.

Key cell therapy product manufacturing equipment:

  • Cell processing isolators (close system)
  • Automatic cell washing/buffer exchanging system
  • Programed freezers
  • Programmed thawers
  • Bioreactor

Key Viral Vectors (VV) manufacturing equipment:

  • •2D culture system for VV production
  • •3D bioreactor for VV production
  • •Column-based purification system Isolator filling station (close system)

QC testing instruments:

  • Flow cytometry
  • qPCR (real time PCR)
  • ELISA reader
  • Automatic cell counter
  • Digital microscope image system
  • Automatic microbial detection system (Rapid sterility test)
  • Cell culture system for cytotoxicity or potency assay
  • Microvolume UV-Vis Spectrophotometers for nucleic acid quantitation
  • Isolator for sterility test

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