Contract research, development and manufacturing organization, WuXi Biologics, announced that five of its manufacturing facilities in Wuxi, China, have passed pre-license inspections (PLIs) conducted by the U.S. Food and Drug Administration (FDA) with no critical issues or data integrity findings.
According to the company, this achievement marks a strong track record of regulatory compliance with a 100% success rate passing PLIs.
The inspections evaluated the company’s quality systems and production operations across two drug substance sites (MFG1 and MFG5) and three drug product sites (DP1, DP2, and DP5). The inspection of DP5 marks the facility’s first FDA regulatory review and enables the company to offer pre-filled syringe (PFS) manufacturing services for commercial clients.
According to the company, it has passed 42 regulatory inspections globally — including 22 by the U.S. and European regulatory bodies — and received 97 product license approvals from regulatory authorities around the world.
In June, the company announced a new site under construction in Chengdu, China. The new microbial manufacturing facility will include both drug substance (DS) and drug product (DP) production, including China’s first dual-chamber lyophilization line and a vial filling line, providing a total DP output capacity of more than 10 million vials annually.