- WuXi Biologics announced that its MFG8 drug substance manufacturing facility in Hebei has successfully passed a U.S. Food and Drug Administration (FDA) Pre-License Inspection (PLI) to support commercial manufacturing of a potential blockbuster autoimmune therapy.
- The inspection reinforces the company’s regulatory compliance record and expands its global commercial manufacturing capabilities.
WuXi Biologics has announced that its MFG8 drug substance manufacturing facility in Hebei has successfully passed a U.S. Food and Drug Administration (FDA) Pre-License Inspection (PLI). The inspection supports commercial manufacturing of a potential blockbuster autoimmune therapy and marks another regulatory milestone for the company’s global CRDMO manufacturing network.
The seven-day inspection, conducted by three FDA inspectors, evaluated MFG8’s quality management system and drug substance manufacturing processes. According to the company, the successful inspection demonstrates the strength of its quality systems, good manufacturing practice (GMP) execution, and integrated capabilities to support global commercial manufacturing.
“MFG8’s successful FDA Pre-License Inspection pass is a strong testament to WuXi Biologics’ commitment to global quality and compliance standards. We are pleased to help bring this potential blockbuster autoimmune therapy to patients through our high-quality manufacturing capabilities.”
Dr. Chris Chen, Chief Executive Officer of WuXi Biologics
The MFG8 facility is equipped with twelve 4,000-liter single-use bioreactors and uses WuXi Biologics’ scale-out manufacturing strategy to provide commercial manufacturing capacity ranging from 4,000 liters to 20,000 liters. The company said the site also incorporates digital technologies, rooftop photovoltaic systems, and sustainable construction practices to support carbon reduction, resource reuse, and recycling.
WuXi Biologics stated that, as of the end of 2025, it had completed 46 regulatory inspections, including 22 by the FDA and European Medicines Agency (EMA), obtained 136 facility license approvals, and maintained a 100% FDA Pre-License Inspection pass rate. The company currently operates 25 drug substance facilities and 18 drug product facilities worldwide, supporting global contract manufacturing activities.
