The site, recognized with the ISPE Facility of the Year Award (FOYA) in 2023, features advanced 6,000L perfusion and 48,000L fed-batch capacity, and now serves as a key manufacturing hub in WuXi Biologics' global network. It delivered a 100% success rate across multiple large-scale Process Performance Qualification (PPQ) runs, including a 16,000-liter scale by combining four 4,000-liter single-use bioreactors - one of the largest cell culture processes using single-use technology worldwide. Global Quality Excellence With 42 regulatory inspections successfully passed - including 22 by the EMA and FDA - and 97 license approvals from agencies worldwide as of the end of 2024, WuXi Biologics maintains a 100% success rate in global regulatory inspections, with no critical findings and zero data integrity issues. This unified quality management system enables seamless technology transfer, site equivalency, and compliance with the highest international standards.