OR WAIT null SECS
Anticipated yearly production is 2 million units
WuXi STA—a subsidiary of WuXi AppTec and a contract development and manufacturing organization (CDMO) serving the life sciences industry—unveiled that its first parenteral formulation manufacturing line at the Wuxi city site is now up and running. This automatic sterile manufacturing line operates in a full isolation system, with an annual capacity of 2 million units.
The CDMO's new filling line also features multiple filling modules and a built-in lyophilizer that will be filling vials, syringes, and cartridges of a full range of sizes, along with producing lyophilized powders.
This aforementioned parenteral formulation manufacturing line and the sterile manufacturing plant at the Wuxi city site have been designed to follow the current good manufacturing practice (cGMP) requirements enforced by the FDA, European Medicines Agency (EMA) and China’s National Medical Products Administration (NMPA). The entire filling process is performed by robotics in a full isolation system, which is intended to limit human interventions and eliminate contaminations.
WuXi STA's drug product platform covers a full range of services, such as solid-state development, pre-formulation, formulation development, and clinical to commercial drug product manufacturing for a variety of oral and injectable dosage forms. In addition to the launch of this parenteral formulation manufacturing line, at this same site, a second sterile filing line with an annual capacity of 10 million units is scheduled to begin operation in Q3 of this year.