WuXi Biologics, a leading global contract research, development and manufacturing organisation (CRDMO), has announced that its MFG8 drug substance manufacturing facility located in Hebei has successfully passed the pre-license inspection (PLI) by the US Food and Drug Administration (FDA), supporting commercial manufacturing for a potential blockbuster autoimmune therapy.
The seven-day FDA inspection conducted by three inspectors covered MFG8’s quality management system and drug substance manufacturing processes.
Passing this inspection further reinforces WuXi Biologics’ outstanding regulatory compliance track record and demonstrates the company’s robust and reliable quality system, proven GMP execution excellence and integrated capabilities to support reliable global commercial manufacturing.
MFG8 is an important part of WuXi Biologics’ global manufacturing network. Equipped with twelve 4,000L single-use bioreactors, the facility leverages WuXi Biologics’ distinctive ‘scale-out’ strategy to offer flexible commercial manufacturing at scales ranging from 4,000L to 20,000L.
In addition, MFG8 incorporates the latest practices in sustainable construction and applies state-of-the-art technologies, including digital platforms and the rooftop photovoltaic system, to advance carbon reduction, resource reuse and recycling.
WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry’s rigorous quality standards. As of the end of 2025, it has successfully passed 46 regulatory inspections, including 22 conducted by the FDA and EMA and secured 136 facility license approvals.
The company also holds an industry-leading record, achieving a 100% pass rate for FDA Pre-License Inspection (PLI). In addition, WuXi Biologics has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU qualified persons.
Currently, the company operates 25 drug substance facilities and 18 drug product facilities within its global network. Its world-class quality and compliance capabilities underpin long-standing trust from clients worldwide.
