Covering a total area of about 11,000 square meters, Xuhui Manufacturing Facility is located in Shanghai Caohejing Hi-Technology Park. It comprises ten 2,000L single-use bioreactors for a total of 20,000L, along with ancillary purification equipment.
Currently, Xuhui Manufacturing Facility and the accompanying quality management systems have passed multiple on-site inspections and/or audits conducted by the NMPA, EMA, EU QP and the international commercial partners, with the production capacity for the current clinical and commercial stage. The facility was granted GMP certification from China and the EU. In September 2020, the drug substance (DS) line and drug product (DP) line for 汉达远® (HLX03, adalimumab injection) have also successfully passed China GMP compliance on-site inspection.
To further scale up the capacity and get prepared for commercialisation, Henlius has commenced the construction of Songjiang Manufacturing Facility (First Plant) since 2019 with a planned production capacity of 24,000L. GMP production for clinical samples has been conducted. 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, when fully operated, is expected to manufacture over 20 products and to become the largest biologic medicine manufacturing facility 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). In August 2020, the pile foundation engineering operation of Songjiang Manufacturing Facility (Second Plant) Phase 1 project, as well as the structure of the main production building were completed.
Henlius leads the trend of adopting single-use technologies in China, particularly single-use bioreactors. Single-use bioreactors are estimated to generally reduce capital expenditure by up to 50% and production costs by up to 25% to 30%, and spare the efforts for clean-up and disinfection after each production cycle, which reduces per-batch production time and decreases the risk of contamination. In addition, 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.