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CATUG operates an integrated R&D, analytical, and GMP manufacturing network designed to support complex therapeutic programs from process development to GMP-oriented CMC execution. With more than 10,000 m² of GMP workshop space, the network supports plasmid DNA, RNA drug substance, LNP drug product, sterile vial filling, and pre-filled syringe filling activities.

 

Across its Suzhou and Wuhan sites, CATUG has established 4 plasmid production lines, 2 RNA drug substance production lines, 3 LNP production lines, 2 sterile vial filling lines, and 1 pre-filled syringe filling line. The facilities are supported by quality control laboratories and a central R&D laboratory of more than 2,000 m², and are designed and operated in alignment with FDA, EMA, and NMPA GMP expectations.

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
  • Lyophilization fill-finish capability for freeze-dried drug products
Wuxi Innovation R&D Center (2000 ㎡)
  • Planned center supporting future platform development, technical collaboration, and global-facing innovation initiatives.
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
 U.S. Client Integration & Innovation Lab
  • U.S. client engagement, technical collaboration, project communication, and early-stage lab-based coordination.
  • 303 A Cellege Rd E, Princeton, NJ 08450 United States
APAC Business & Innovation Hub
  • Hong Kong Science Park (HKSTP) presence supporting APAC client engagement, cross-border collaboration, and regional business development.
  • 5/F, Building 19W, 5 Science Park East Avenue, Hong Kong Science Park
Europe Business Office
  • Located in the Basel biotech cluster, supporting European client engagement, partnering, and business development
  • Hegenheimermattweg 167A 4123 Allschwil, Switzerland

 

 

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