Multi-step purification effectively removes impurities.
Optimized upstream and downstream processes ensure high-yield vector production.
Three-stage filtration with 0.2 μm sterile filtration ensures product safety.
Modular equipment minimizes manual intervention.
Intermediate product cryopreservation enables flexible scheduling and stable manufacturing.
100% QC testing with comprehensive quality monitoring throughout the process.
1F:Logistics, Manufacturing & Utilities(2,300 m²）
2F:Manufacturing (2,300 m²）
3F:QC Laboratory & Viral Vector Manufacturing(2,300 m²）
1F:Innovation Center Warehouse
3F:Microbiology Laboratory & AD Laboratory (1,500m²)
4F:Office Area（1500m²)
Located at Buildings B15 and B21 (Floors 1, 3 and 4), BioBAY, No. 218 Sangtian Street, Suzhou, China, covering nearly 11,500 m²
Capable of producing lentiviral vectors, as well as supporting the commercialization of cell therapy products and the production of drugs for clinical trials.
There are 6 independent production modules with modular design, supporting flexible and efficient production organization and management.
Obtained the "Drug Production License" issued by Jiangsu Provincial Drug Administration in June 2020, and carried out production and quality management in accordance with applicable GMP requirements.
Key Capabilities for Commercial-Scale Production
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Modular production layout
Independent production modules support flexible production organization and management.
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Experience in commercial-scale production
Continuously accumulate experience in the commercial-scale manufacturing of cell therapy products
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Lentiviral Vector Process
Establish production process capabilities for lentiviral vectors using a suspension-based system
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End-to-End Quality Management
Ensuring the production process through quality control and traceability systems
- First-pass production success rate
- 99%
Production performance of Beinuoda® from its market launch up to November 12, 2026
- Product Delivery Rate
- 100%