WuXi Biologics, a global contract research, development and manufacturing organization (CRDMO) headquartered in Shanghai, China, said it has successfully completed a U.S. Food and Drug Administration (FDA) Pre-License Inspection (PLI) for its MFG8 drug substance manufacturing facility in Hebei, enabling the site to support commercial manufacturing of an investigational autoimmune therapy.

According to the company, the seven-day inspection evaluated the facility’s quality management system and drug substance manufacturing operations. The approval supports commercial supply of what the company described as a potential blockbuster autoimmune therapy.

MFG8 is part of WuXi Biologics’ global manufacturing network and is equipped with 12 single-use bioreactors with 4,000-liter capacity each. The facility uses the company’s scale-out manufacturing approach, allowing commercial production ranging from 4,000 to 20,000 liters. The site also incorporates digital manufacturing technologies and sustainability features, including a rooftop photovoltaic system designed to reduce carbon emissions and improve resource efficiency.

The announcement follows several recent regulatory and manufacturing milestones for WuXi Biologics. Last week, the company received GMP certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) for three manufacturing facilities in Wuxi, China, enabling end-to-end commercial production of an anti-PD-L1 monoclonal antibody for the Brazilian market. The certification followed a five-day inspection with no findings. In late June, WuXi Biologics also completed its first GMP production campaign at MFG17, its 25th drug substance manufacturing facility, at its Shanghai Fengxian site.

According to the announcement, WuXi Biologics has completed 46 regulatory inspections including 22 by the FDA and European Medicines Agency, maintains a 100% FDA PLI pass rate, has received 136 facility license approvals, and has undergone more than 1,800 GMP quality audits by global customers. The company’s global manufacturing network includes 25 drug substance facilities and 18 drug product facilities.