Covering a total area of about 11,000 square meters, our Xuhui Manufacturing Facility is located in Shanghai Caohejing Hi-Technology Park. It comprises six 2,000L and four 500L single-use bioreactors for a total of 14,000L, 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 EU QP and the international commercial partners, with the production capacity for the current clinical and commercial stage. The first product, 汉利康 ® (HLX01, rituximab injection), was granted the Certificate of Good Manufacturing Practices (GMP) for Pharmaceutical Products. Meanwhile, the drug substance (DS) line and drug product (DP) line for HLX02 (trastuzumab for injection) have successfully passed EU GMP on-site inspection. Upon the results, we received two EU GMP Certificates (Certificate of GMP Compliance of a Manufacturer) from Poland’s Chief Pharmaceutical Inspector.
To further scale up the capacity and get prepared for commercialisation, we have commenced the construction of Songjiang Manufacturing Facility (First Plant) since 2019 with a planned production capacity of 24,000L including formulation filling line. 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 with the aim of potentially serving 3 million patients around the world. 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).
We lead 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, we strive to achieve further cost efficiency through the focus on developing continuous process technologies in-house (instead of standard batch feeding process), 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.