Facilities
Facilities

CATUG has set two R&D centers and commercial bases in Suzhou and Wuhan, with the GMP workshop area covers more than 10,000 ㎡, 4 plasmid production lines, 2 RNA drug production lines, 3 LNP production lines, 2 vial sterile drug product filling line and 1 pre-filled injection drug product filling line, which are compliant with NMPA, FDA, and EMA GMP, have been established. In addition, CATUG is equipped with quality control laboratory and R&D site, including a R&D central laboratory of more than 2,000 ㎡.

CATUG
Dominant Advantages
  • GMP-grade workshop in line with FDA, EMA and NMPA criteria
  • Unidirectional flow line and independent air-conditioning system, which can prevent cross-contamination
  • End to End preparation mode, CGT/nucleic acid drug full-chain service
Compliance services available
  • Overall research protocol for CMC
  • Clinical sample production
  • Technology transfer
  • MAH commercial production
Wuhan GMP production base (2500㎡)
  • Technology transfer site, GMP pilot-scale workshop, quality control laboratory are in place to cover a full set of functional areas, boosting the project transfer and incubation efficiency
  • it can meet the requirements for compliance GMP-grade sample production and release at IIT, Pre-IND, IND and Phase I.
  • One 20 L-100 L commercial scale plasmid production line
  • One 2 L IVT commercial scale mRNA+LNP production line
  • One filling line
Suzhou GMP production base(8500 ㎡)
  • Designed by a world-class company in accordance with international standards (NMPA, EMA, FDA);
  • Capable to meet the requirements for GMP-compliant sample production and release at phases such as IIT, Pre-IND, IND, clinical trial samples and commercial product production
  • One 500 L commercial scale plasmid production line
  • Two 50 L commercial scale plasmid single-use production line
  • One 20 L IVT commercial scale mRNA single-use production line
  • Two commercial scale LNP encapsulation single-use production lines with different delivery
  • One sterile drug product filling production line for vials with an annual capacity of 10 million vials
Wuhan R&D Center (1500 ㎡)
  • Flexible and efficient plasmid customization and process development platform
  • Plasmid specific analytical procedure development platform
Suzhou R&D Center (2000 ㎡)
  • Flexible and efficient plasmid customization and process development platform
  • High-yield and efficient mRNA customization and process development platform
  • Plasmid and mRNA specific analytical procedure development platform