Manufacturing
HPV Vaccine Manufacturing Facility
At present, the company is building an HPV vaccine production facility in Taizhou, Jiangsu Province, with an annual production potential of up to 20 million doses of HPV nine-valent vaccine in the first phase. The Company's new manufacturing facility is designed and built to produce vaccines in compliance, which meets the WHO Prequalification (WHO PQ) Standards with full production capacity and ready for commercial production.
The production base covers a total area of 122.92 mu, with a total construction area of 103,068.80 m2. The main construction contents include HPV vaccine building, comprehensive warehouse, quality inspection and development building, animal room, power center and other newly built production plants. Through the purchase of fermentation equipment, purification equipment, pre-potting production line and other production equipment, the project adopts fermentation, purification, preparation and other production technologies to build a number of stock liquid production lines and potting production lines.
HPV Vaccine Manufacturing Facility Address: No.888, Yaocheng Avenue, China Medical City, Taizhou City.
Innovation Vaccine (CHO cell) Manufacturing Facility
We completed the construction of our manufacturing facility for innovative vaccines (CHO cell) in Taizhou, Jiangsu province in November 2021 and obtained a vaccine manufacturing license issued by Jiangsu MPA. The manufacturing facility has a total GFA of approximately 17,000 sq.m., and can also be used for the manufacturing of a variety of innovative vaccines (CHO cell), including recombinant shingles vaccines. On April 9, 2022, the Company received the European Union (EU) Qualified Person Declaration issued by a Qualified Person (QP) for our innovative vaccines (CHO cell) manufacturing facility in Taizhou.
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 Innovation vaccine.
At present, the manufacturing facility is mainly used for the production of clinical samples of the new adjuvant recombinant shingles vaccine in China Phase 1 and Phase 3, and can support the production and supply of the vaccine at the future commercial level.