WuXi STA opens new sterile manufacturing line at Wuxi City site

WuXi STA, a subsidiary of WuXi AppTec, rolled out its first parenteral formulation manufacturing line at its Wuxi City production facility.

The latest addition to the site is a fully automatic sterile manufacturing line that operates in a full isolation system and can produce 2 million units a year. The entire filling process of the new line uses robotics to streamline the process and eliminate contamination.

The parenteral filling system uses a built-in lyophilizer to load vials, syringes and cartridges in a range of sizes and can produce lyophilized powders. The cost of the new line wasn’t disclosed.

RELATED: WuXi’s Shanghai facility gets FDA nod in first preapproval inspection

A second sterile filing line is expected to begin operating at the site sometime in the third quarter this year, the company said. The line will have an annual capacity of 10 million units.

Earlier this month, WuXi STA’s manufacturing facility in Shanghai passed its first FDA drug product preapproval inspection following a five-day inspection by the U.S. regulatory agency held in late October. During that FDA inspection, the facility passed two additional preapproval inspections by China’s regulatory agency, the NMPA, for a pair of innovative drugs from the company’s partners.