WuXi STA, a subsidiary of WuXi AppTec, today announced its first parenteral formulation manufacturing line at the Wuxi city site is now in commission. This wholly automatic sterile manufacturing line operates in a full isolation system with an annual capacity of 2 million units.
The industry-leading automatic parenteral filling line features multiple filling modules and a built-in lyophilizer to fill vials, syringes, and cartridges of a full range of sizes, as well as to produce lyophilized powders. Different filling modules can be switched rapidly, allowing for maximum flexibility and production efficiency.
This new parenteral formulation manufacturing line and the sterile manufacturing plant at Wuxi city site are designed per cGMP requirements by U.S. FDA, EMA, and China NMPA, equipped with the industry latest generation of isolation system and filling machine. The entire filling process is performed by robotics in a full isolation system, designed to minimize human interventions and eliminate contaminations to ensure high product quality.
WuXi STA’s drug product platform covers a full range of services including solid-state development, pre-formulation, formulation development, and clinical to commercial drug product manufacturing for a broad range of oral and injectable dosage forms. In addition to the launch of this parenteral formulation 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.
With the addition of the sterile manufacturing line, WuXi STA’s new modality CRDMO platform provides an end-to-end solution for oligonucleotides, peptides as well as complex conjugates from API to drug product, from discovery to commercial manufacturing.
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “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, customized, flexible solutions to accelerate drug development to bring more innovative medicines to market for patients worldwide.”