Chinese company Clover Biopharmaceuticals plans to build a new biomanufacturing facility in the Changxing Economic and Technological Development Zone (CETDZ) of Zhejiang, China.
The new facility will be used to manufacture biosimilars and biological fusion protein products such as novel drugs.
Construction is expected to begin Q2 2018 and completed by the end of 2018.
The new biomanufacturing facility will be situated at CETDZ in Changxing, Zhejiang.
Designed to develop the biopharmaceutical industrial cluster, this national economic development zone is situated at the centre of the Yangtze Delta and is surrounded by 50 major cities, including Shanghai, Hangzhou, Nanjing, Ningbo, Suzhou, Wuxi and Wuhu.
The facility will be connected by one national sea-route, two national highways, two highways and three railways.
Clover Biopharmaceuticals’ new facility will be equipped with two 2,000l bioreactors provided by GE.
It will operate on GE Healthcare’s manufacturing platform FlexFactory™, a centrally automated and flexible biomanufacturing platform that enables manufacturers to establish biopharmaceutical manufacturing capacity at an existing or new facility.
The platform will enable Clover Biopharmaceuticals to meet local and global healthcare needs by quickly introducing new treatments to the market. It will also allow the company to reach global markets by complying with regulatory and quality requirements.
The platform features single-use technologies and associated process hardware, and is equipped with automation and control components for the manufacturing of biopharmaceuticals.
The new facility will be used to produce SCB-808, a biosimilar candidate of Enbrel® (etanercept) that is used for the treatment of rheumatoid arthritis.
Existing biosimilar formulations of etanercept that are already available in the Chinese market were not compared to the original Enbrel® formulation in clinical trials to test its bioequivalence. The existant formulations are also only available as lyophilised powders that need to be reconstituted by a trained medical professional before administration to patients.
The etanercept formulation being developed by Clover Biopharmaceuticals is offered as a prefilled syringe that patients can self-administer.
The company received clinical trial application (CTA) approval for conducting clinical trials on SCB-808 from the Chinese Food and Drug Administration (CFDA). Phase I clinical trials on SCB-808 biosimilar are expected to commence in mid-2018.
China has one of the world’s fastest-growing biopharmaceutical industries. Valued at $13bn in 2015, the market is estimated to grow at an annual rate of 13% over the next few years. Construction of the new biomanufacturing facility will tap into the growing Chinese biopharmaceutical market.
The Chinese Government’s 13th five-year plan focuses on biotechnological innovation and is expected to further promote the growth of the pharmaceutical market. The plan includes the development of 20 science parks for biomedicine by 2020 to fast-track local research and development (R&D) activities.
Clover Biopharmaceuticals is a clinical-stage biotechnology company headquartered in Chengdu, China. The company is engaged in the discovery, development and commercialisation of transformative biologic therapies for oncology and autoimmune diseases.
The company utilises its proprietary Trimer-Tag© technology platform for the development of novel biologics targeting trimerisation-dependent pathways. The technology attacks trimerisation-dependent disease targets including tumour necrosis factor (TNF) superfamily, and enveloped ribonucleic acid (RNA( virus antigens.
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