Protect Human Health with Best−in−Class Vaccines
Protect Human Health with Best−in−Class Vaccines
Protect Human Health with Best−in−Class Vaccines
江苏 Recbio
生物技术有限公司.有限公司.
Founded in 2012, 江苏瑞比奥科技有限公司.有限公司. (hereafter referred to as Recbio or the Company; stock code: 2179.HK) is an innovative vaccine company propelled by internally developed technologies. Committed to our mission of " Protect human health with best-in-class vaccines", we have cultivated a robust portfolio of vaccine products with exclusive rights, addressing the substantial unmet needs in the realm of high-impact infectious diseases. Over the course of more than two decades, Recbio has meticulously built three pioneering platforms: a novel adjuvant platform, 蛋白质工程平台, and an immunological evaluation platform, making us one of the few global companies capable of both developing and manufacturing the complete range of novel adjuvants.
Leveraging the close integration of our three platforms, we are consistently creating promising vaccine candidates. Fueled by these innovative platforms, the Company has forged a high-value portfolio of innovative vaccines, encompassing over ten potential blockbuster varieties. These encompass areas such as cervical cancer, 带状疱疹, RSV感染, and other prevalent high-burden diseases, and have emerged as leading products in terms of development and clinical progress in China.
Having been honed and refined over the course of a decade, Recbio is poised to reap the benefits as several products are nearing commercialization.
制造业 设施
人乳头状瘤病毒疫苗 制造工厂
目前, the company is building an HPV vaccine production facility in Taizhou, 江苏省, 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,Obtained EU PQ certification 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, 综合仓库, quality inspection and development building, 动物的房间, power center and other newly built production plants. Through the purchase of fermentation equipment, 净化设备, pre-potting production line and other production equipment, 本项目采用发酵, 净化, preparation and other production technologies to build a number of stock liquid production lines and potting production lines.
人乳头状瘤病毒疫苗 制造工厂 Address: No.888, Yaocheng Avenue, China Medical City, Taizhou City.
Innovation Vaccine (CHO cell) 制造工厂
We completed the construction of our manufacturing facility for innovative vaccines (CHO cell) in Taizhou, 江苏 province in November 2021 and obtained a vaccine manufacturing license issued by 江苏 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 带状疱疹 vaccines. 4月9日, 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 制造业 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), 等., this EU QP audit mainly focused on the bulk and preparation of antigen and the novel adjuvant BFA03, covering manufacturing management system, 质量管理体系, production equipment and facility management system, validation and computerized systems, 物料管理系统, 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 质量管理体系 have met EU GMP standards, laying a solid foundation for the high-quality development and future international commercialisation of ReCOV.
目前, the manufacturing facility is mainly used for the production of clinical samples of the new adjuvant recombinant 带状疱疹 vaccine in China Phase 1 and Phase 3, and can support the production and supply of the vaccine at the future commercial level.
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