WuXi STA, a subsidiary of WuXi AppTec, announced that its first drug product Continuous Manufacturing (CM) line for oral solids is in operation at the drug product site located in Wuxi city, China. This new CM line provides global customers an enhanced oral drug development solution, enabling higher yields and shortened timelines to market.
WuXi STA’s continuous manufacturing line features continuous direct compression equipment with unit operations including dispensing, blending, lubrication, tablet compression, and coating. The equipment design complies with the global cGMP regulations. Process Analytical Technology (PAT) is implemented within the CM line to monitor blending uniformity, allowing for real-time analysis and control during production to ensure high product quality.
WuXi STA’s drug product facilities across North America, Europe, and Asia have been inspected by major regulatory agencies including US FDA, EMA, China NMPA, SwissMedic, Japan PMDA, and South Korea MFDS to support global customers with clinical and commercial drug product manufacturing services. The Wuxi city site, where this new CM line was launched, is an integrated formulation development and manufacturing campus with comprehensive analytical platform for both oral and injectable formulations.
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “I am glad that our first oral solid-dose drug product continuous manufacturing line has been launched in the Wuxi city site. As a trusted partner and a global enabler, WuXi STA will continue to build first-class facilities with cutting-edge technologies to make more innovative medicines accessible to patients worldwide.”