Our integrated CMC capabilities include cell line generation, cell culture technology, process development and controls, product characterization, comprehensive analytics, and formulation development. Our CMC team is experienced in NMPA/FDA/EMA cGMP guidelines.

We use CRO/CMO services to manufacture our clinical trial materials for iTAb following cGMP guidance.

Quality

Data quality and product quality are the souls of our company.

The quality system is built on solid science and follows NMPA GMP, cGMP, ICHQ10 regulatory guidelines.