Covering a total area of about 11,000 square meters, Xuhui Manufacturing Facility is located in Shanghai Caohejing Hi-Technology Park. It has a total capacity of 20,000L, along with ancillary purification equipment. The facility and its accompanying quality management systems, certificated by China and the EU GMP, have also passed multiple on-site inspections and/or audits conducted by the NMPA, EMA, the EU QP and the international commercial partners.
To further scale up the capacity, Henlius has completed in Songjiang Manufacturing Facility (First Plant) the construction of 24,000L production capacity including the commission and verification of all 12 2,000L bioreactors and the freeze-drying drug product production workshop, as well as several batches of process validation.
Meanwhile, the construction of Songjiang Manufacturing Facility (Second Plant) is also commenced. Covering about 130,000 square meters (200mu) with an investment amount of over ¥10 billion 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 Manufacturing Facility (Second Plant), when fully operated, is expected to manufacture over 20 products and 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, with 36,000L capacity in plan, the structure of production buildings has been completed and main structure inspected.
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. The first batch of non-GMP production for downstream continuous manufacturing of a single project is completed in Songjiang Manufacturing Facility (First Plant). Meanwhile, steady progress has been made in the localization of critical consumables to better mitigate the risk of material supply against the global backdrop.