Technology Platform 154 Views 2020-04-08 10:59
The use of fully enclosed, single-use, and fully automated cell production equipment represents the most advanced aspect of Persongen's manufacturing process for cell therapy products. Currently, most marketed autologous cell therapy products (primarily CAR-T) still rely on modular process models. This traditional approach requires a highly controlled background environment (typically Grade B), a large number of personnel, and extensive experience in sterile drug production. Additionally, to mitigate risks such as cross-contamination, confusion, and errors, this conventional model cannot achieve compact production line layouts, and capacity expansion heavily depends on increasing factory space and personnel.
In contrast, the production process utilizing fully enclosed, single-use, and fully automated cell production equipment addresses all these challenges comprehensively. This advanced manufacturing process can operate in a lower-cleanliness class background environment, significantly reduces the difficulty of training qualified staff while improving their efficiency, and enables capacity expansion through increased equipment investment due to the integrated and compact nature of the production system.
PersonGen possesses the largest-scale single-use, fully enclosed, and fully automated cell production line in the Asia-Pacific region, with its core products in the clinical stage all being manufactured using this advanced process. This approach eliminates risks associated with major post-approval process modifications and equips the company to efficiently meet increased order demands following product commercialization.