WuXi Biologics reports that it has successfully launched the GMP operation of its new drug product facility located in Wuxi, China, which is the eighth operational drug product facility in the global network of WuXi Biologics.
The 12,000m² drug product facility, called DP2, features a modern isolator filling line for the continuous high-speed wide-size ranger production–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 solutions to meet customers’ needs, according to the company. DP2 is expected to 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 and evolving global regulatory requirements, notes Chris Chen, PhD, CEO of WuXi Biologics.
With its advanced 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 any client project within four weeks, says Chen, adding that 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, to not only provide customized end-to-end manufacturing services for clients, but also accelerate the process of high-volume clinical and commercial projects, comments Chen.
“We’re excited about the successful GMP launch of the first fully automated vial packaging line as well as DP2, the largest commercial drug product facility at WuXi Biologics,” he continues. “These will allow us to further provide high-yield, high-efficiency, and high-quality drug product services to support our global clients’ clinical trials, product registration, and commercial authorization.”