The manufacturing line and the sterile manufacturing plant at Wuxi city site are designed per cGMP requirements by the FDA, EMA, and China NMPA
WuXi STA, a subsidiary of WuXi AppTec, has announced its first parenteral formulation manufacturing line at the Wuxi city site is now in commission. The automatic sterile manufacturing line operates in an isolation system with an annual capacity of 2 million units.
The parenteral filling line features multiple modules and a built-in lyophiliser to fill vials, syringes, and cartridges in a range of sizes, as well as to produce lyophilised powders. Different filling modules can be switched in, enabling flexible and efficient production.
The manufacturing line and the sterile manufacturing plant at Wuxi city site are designed per cGMP requirements by the FDA, EMA, and China NMPA. The entire filling process is performed by robotics in an isolated system, designed to minimise human contact and eliminate contaminations to ensure product quality.
The company’s drug product platform covers solid-state development, pre-formulation, formulation development, and clinical to commercial drug product manufacturing for a range of oral and injectable dosage forms. In addition to the launch of this manufacturing line, a second sterile filing line with an annual capacity of 10 million units is scheduled to start operation in Q3 this year at the same site.
Dr Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA, said: “I am glad that our first fully automatic parenteral formulation manufacturing line has been launched in the Wuxi city site. WuXi STA will continue to build first-class facilities with cutting-edge technologies. We strive to provide our global partners the most advanced, customised, flexible solutions to accelerate drug development to bring more innovative medicines to market for patients worldwide.”