WuXi Biologics Launches GMP Ops at New Facility

WuXi Biologics has successfully launched the GMP operation of its new drug product facility in Wuxi, China, which is the eighth operational drug product facility in company’s global network.
 
The 12,000m² drug product facility, called DP2, features a state-of-the-art isolator filling line for the continuous high-speed production of a wide range of sizes – from 2R to 50R of liquid and 20m2/40m2 of lyophilization. The facility can switch rapidly between different specifications to maximize its filling efficiency, providing flexible drug product manufacturing services to meet customer need. DP2 will increase up to 60 million vials for commercial drug production of biologics per year. This facility serves as an example of WuXi Biologics’ implementation of single-use technology as it utilizes disposable peristaltic pump filling systems and sterile filtration systems in pre-use post sterilization integrity testing (PUPSIT), which meet current global regulatory requirements.
 
With its layout and equipment, the facility effectively eliminates cross-contamination and ensures product sterility while accelerating drug product services across multiple modalities – such as monoclonal antibodies, bispecifics and fusion proteins – and enables the company to initiate client projects within four weeks. The application of both single-use and stainless-steel formulation systems helps reduce energy consumption, resulting in greater productivity and lowered environmental impact.
 
In addition, WuXi Biologics has also launched the GMP operation of a new Drug Product Packaging Center (DPPC) which includes the company’s first fully automated vial packaging line. This packaging line is designed to meet U.S. FDA, EMA and China’s NMPA GMP requirements and will leverage new technologies – including anti-forgery drug tracking as well as automatic intelligent labeling and packaging.