WuXi Biologics' MFG8 Facility Receives FDA Approval for Autoimmune Therapy Production

WuXi Biologics, a global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG8 drug substance manufacturing facility in Hebei has passed a Pre-License Inspection (PLI) by the U.S. Food and Drug Administration (FDA). The approval allows the facility to support the commercial manufacturing of a potential autoimmune therapy.

The seven-day FDA inspection, conducted by three inspectors, focused on the facility's quality management system and drug substance manufacturing processes. Passing this inspection reinforces the company's regulatory compliance record and demonstrates its robust quality system and capacity for global commercial manufacturing.

MFG8 is a key component of WuXi Biologics' global manufacturing network. The facility houses twelve 4,000-liter single-use bioreactors and employs a "scale-out" strategy for flexible commercial production ranging from 4,000 to 20,000 liters. The site also incorporates sustainable construction practices and utilizes digital platforms and a rooftop photovoltaic system to reduce carbon emissions.

WuXi Biologics has a history of successfully undergoing regulatory inspections. The company has passed 22 inspections by the FDA and the European Medicines Agency (EMA) and operates 25 drug substance facilities and 18 drug product facilities worldwide. Previously, the company reported a 100% pass rate for FDA Pre-License Inspections.