Land Area
CMC Team
2000L Raw Liquid Production Line
Annual Antibody Production Capacity
We have mature commercial scale internal production capabilities that can seamlessly coordinate our drug development activities at all stages. Our CMC-focused subsidiary is equipped with a state-of-the-art manufacturing facility established according to the cGMP standards of China,the United States and the EU in Taizhou.
We have a CMC team of more than 150 members at our Taizhou Manufacturing Facility,covering the full-cycle development of monoclonal antibodies. Our drug substance manufacturing site has four 2,000L single-use bioreactors and one downstream purification/production line with an annual manufacturing capacity of approximately 300 kg therapeutic antibodies. Our drug product manufacturing site has one vial fill-finish and packaging production line, with a manufacturing capacity of 18,000 vials/hour, and one prefilled syringe production line, with a manufacturing capacity of 9,000 syringes/hour.
In April 2021, we received a Drug Manufacturing Certificate from Jiangsu Medical Products Administration for the production of QX001S at Taizhou Manufacturing Facility. We believe that our own production capacity that meets cGMP standards, combined with our strong research and development capabilities, will enable us to control costs and ensure stable clinical and commercial drug supply.
We have established an internal quality management system covering the entire lifecycle of candidate drugs in accordance with the cGMP standards of the National Drug Administration, FDA, and EMA.
We continuously checks and updates quality management system by monitoring laboratory control systems, production systems, material systems, facilities and equipment systems, packaging and labeling systems, and other related activities and equipment to ensure compliance with regulatory requirements. We use advanced information management systems (such as warehouse management system (WMS), document management system (DMS), laboratory information management system and comprehensive analysis system covering the life cycle of the company's candidate drugs) to dynamically control materials, products and related information throughout the process, ensuring reliable and traceable data.
Led by Qyuns management team, we strictly control quality, continuously optimize and improve the quality system, and shape our own quality culture.
