Henlius has 3 manufacturing facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current total commercial production capacity has reached 48,000 liters and maintains stable supply in China, Southeast Asia, Europe, MIDE and Latin America.
Covering a total area of about 11,000 square meters, Xuhui Facility is located in Shanghai Caohejing Hi-Technology Park. It has a total capacity of 24,000L. The facility and its accompanying quality management systems have passed on-site inspections and audits conducted by the NMPA, EMA, PIC/S participating members Indonesia’s BPOM and Brazil’s ANVISA, the European United (EU) QP and international commercial partners. To further scale up the capacity, Henlius started the construction of Songjiang First Plant in 2019 and has commercial capacity of 24,000L. It was successively GMP-certificated by China, the EU and the U.S. regulatory agencies.
Meanwhile, the construction of Songjiang Second Plant is also commenced. Covering about 130,000 square meters (200mu) and located in the Western Technology Park of National-level Shanghai Songjiang Economic & Technological Development Zone as a part of G60 S&T Innovation Valley of Yangtze River Delta, Songjiang Second Plant, when fully operated, is expected to become one of the largest biologic medicine manufacturing facilities in China. The facility strictly follows international GMP standards and adopts new technologies (continuous flow technology etc.) to align with the design criteria of biomedical automation, informatization, and intelligence (Pharmaceutical Industry 4.0). To date, for its Phase 1 project, the first and second stages aim to achieve a total capacity of 36,000L. The third stage aims to reach 60,000L capacity.
Henlius leads the trend of adopting single-use technologies in China, particularly single-use bioreactors. Henlius strives to achieve further cost efficiency through the focus on developing continuous process technologies in-house, which is expected to significantly bring down per-unit manufacturing costs and reduce liquid and solid wastes pollution, while at the same time significantly increasing productivity. In 2021, Henlius successfully launched China’s first continuous manufacturing clinical production workshop to achieve end-to-end continuous production and thus improving productivity with stable and controllable quality. Meanwhile, steady progress has been made in the localization of critical consumables to better mitigate the risk of material supply against the global backdrop.
