Large-scale Manufacturing for Plasmid & lentivirus
● Regulatory qualified master cell banks and working cell banks for both plasmid and lentiviral production.
● Established and validated processes for plasmid, lentivirus and CAR-T cell productions, supporting multiple IND enabling studies, IND filing, and early to pivotal clinical trials.
● Scalable upstream process in bioreactors for plasmid and lentivirus production.
● Serum-free suspension culture process for lentivirus.
● Scalable downstream purification process and established quality control.
● Capacity for plasmid: 2,000/year; Capacity for lentivirus: 2,000/year.
● The safest third generation lentivirus packaging system.
● Professional CMC study for cell therapy products and can offer full CMC services for customers.