The company completed construction of a GMP standard manufacturing facility for ReCOV in November 2021, with a total floor area of approximately 17,000 square meters and a maximum annual production capacity of 300 million doses. In the same month, the company received a Drug Production License (scope: Recombinant two-component COVID-19 vaccine [CHO cell]) issued by Jiangsu Provincial Drug Administration, indicating that The Manufacturing base in Taizhou, Jiangsu province is fully equipped for the production of recombinant two-component COVID-19 vaccine (CHO cell).
The COVID-19 Vaccine Manufacturing Facility has received the European Union (EU) Qualified Person Declaration issued by a Qualified Person (QP) on April 9,2022.
Pursuant to Eudralex Vol 4 regulations (EU Good Manufacturing Practice) and the guiding principles of International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Parenteral Drug Association (PDA) and International Society for Pharmaceutical Engineering (ISPE), etc., this EU QP audit mainly focused on the bulk and preparation of antigen and the novel adjuvant BFA03, covering manufacturing management system, quality management system, production equipment and facility management system, validation and computerized systems, material management systems, product testing and release management and other aspects of a comprehensive systematic and in-depth inspection. This signifies the Group’s manufacturing facility in Taizhou and its quality management system have met EU GMP standards, laying a solid foundation for the high-quality development and future international commercialisation of ReCOV.