Hillgene

Overview

Hillgene (谱新生物) is a contract development and manufacturing organization (CDMO) founded in 2017, headquartered in Suzhou, China. The company specializes in cell therapy drug manufacturing and commercialization, positioning itself as a leading CDMO service provider in the cell and gene therapy (CGT) sector.

Core Capabilities

Cell Therapy Manufacturing:

• CAR-T cell CDMO complete solutions
• TCR-T cell CDMO complete solutions
• CAR-NK cell CDMO complete solutions
• UCAR-T cell CDMO complete solutions
• Allogeneic and autologous cell therapy manufacturing

Supporting Services:

• Nucleic acid (plasmid/mRNA) manufacturing
• Lentiviral vector production
• Immune cell manufacturing
• Stem cell manufacturing
• Regulatory consulting (药政咨询)
• Quality control and testing services

Testing & Analytics Center:

• Rapid release testing platform
• Standardized batch release testing
• Pharmaceutical quality control research
• Specialized testing projects

Infrastructure & Regulatory

• Suzhou headquarters: 10,000 m² GMP manufacturing facility
• Suzhou R&D center: 3,000 m²
• European GMP facility in Belgium
• 23+ successful IND applications
• 200+ clinical cell preparation applications
• FDA DMF filing approval for genetically modified K562 feeder cells
• Provincial-level "specialized, refined, and innovative" (专精特新) enterprise designation

Market Position

Hillgene serves as an integrated solution provider for cell therapy drug industrialization, supporting projects from IIT (investigational IND-enabling studies) through IND, clinical trials, and commercial-scale production.