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Drug Substance cGMP Manufacturing

All CMC development and BSL-2 cGMP manufacturing  activities located in one area: Hangzhou’s BioPharm Town.

  • Convenient Transportation
    • 7 km (10 minutes by car) between the plasmid production and viral production sites  
    • 15 km from Xiaoshan International Airport (Hangzhou), 160 km from Shanghai (2 hours by car or 1 hour by high-speed train)from Pudong International Airport 

 

  • Excellent Talent Pool
    • Extensive experience: leadership team has over 10 years of industry experience Highly educated staff: 15% Ph.D., 66% M.S., 17% B.S.


BSL-2 Vaccine Drug Substance (DS) & Drug Product (DP) Manufacturing Capacity In Hangzhou, China

 


 

  • Process Development
    • Material generation from up to 50 L suspension culture or from adherent culture in cell factories
    • End-to-end offering from packaging cell line through process development
    • Full package of analytical methods development, qualification and transfer to Quality Control (QC)
    • Operational by Q3 2020

 

  • MFG13 State-of-the-Art BSL-2 cGMP Viral DS Manufacturing Facility
    • 2,500 m2, GMP ready by Q1, 2021
    • One suite for suspension culture, including microcarrier based adherent cell culture; 50-1,000 L 
    • One suite for suspension culture, including microcarrier-based adherent cell culture; 50-1,000 L capacity
    • One suite for adherent cell culture: Cell Factory, Hyperstack 
    • One flexible purification suite, with extensive utilization of advanced single-use technologies