Jiangsu Recbio

Biotechnology Co., LTD.

Founded in 2012, Recbio is an innovative vaccine company with independent research and development technology as its core driving force. It is committed to building a full value chain of innovative vaccines, covering research and development, production and commercialization. The Company has always adhered to the mission of “creating first-class vaccines and protecting human health”. With a strong research and development engine comprising of novel adjuvants, protein engineering, immunological evaluation and other core technology platforms, strategically focusing on disease areas with significant burden such as cervical cancers COVID-19, shingles, adult TB, HFMD and flu etc., the Company has established a high-value product pipeline consisting of 12 vaccine candidates with independent intellectual property rights, in order to meet the under-fulfilled public health needs. For more information, please visit https://www.recbio.cn/.

Press Release

Completion Of Subject Enrollment And Vaccination For The Comparative Study Between ReCOV And mRNA Vaccines

2022-08-19

Recbio announces Phase III Clinical Trial Progress Of Recombinant HPV 9-Valent Vaccine

2022-08-10

Manufacturing Facility

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 10 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 with China's GMP regulations, 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.

COVID-19 Vaccine Manufacturing Facility

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.

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