The new facility will support a robust pipeline of biopharmaceuticals, including a biosimilar to Enbrel® for the treatment of rheumatoid arthritis
Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, has chosen GE Healthcare’s FlexFactory, a biomanufacturing platform based on single-use technologies, for its new facility located in Changxing, Zhejiang in China. The new facility will mainly be used to produce biological fusion protein products, including innovative drugs and biosimilars. This will help Clover Biopharmaceuticals to bring local access to biologic therapies faster, while also opening global markets through the proven track record of FlexFactory in meeting global regulatory requirements and quality standards. The biomanufacturing facility includes two 2000 liter bioreactors from GE, and it will be operational in the latter half of 2018.
“Adopting high-quality technologies and driving innovation in our manufacturing operations is important for Clover Biopharmaceuticals. GE’s FlexFactory represents the latest in biomanufacturing technologies, and it will help us establish flexible production capacity quickly, while fulfilling good manufacturing practices (GMP) requirements,” said Dr. Peng Liang, Co-founder, Chairman and President of Clover Biopharmaceuticals.
“The first therapeutic product produced using this biomanufacturing platform is SCB-808, a prefilled syringe formulation Enbrel® (etanercept) biosimilar candidate for the treatment of rheumatoid arthritis. We believe that SCB-808 addresses a major unmet need for patients in China and hope that we can provide patients with safer, more efficacious and convenient modern biologic therapies.”
Clover Biopharmaceuticals’ new production facility will be located in one of the national economic development zones in China, Changxing Economic and Technological Development Zone, where a new biopharmaceutical industrial cluster is being developed. China has a broader strategy on biotechnological innovation per the government’s 13th Five-Year Plan, and there are plans to build up to twenty science parks for biomedicine by 2020 to accelerate local research and development activities. In 2015, the Chinese biopharmaceutical market was valued approximately at USD 13 billion, and the estimated annual growth rate (CAGR) is around 13 percent for the next few years (1).
“China has one of the fastest growing biopharmaceutical industries in the world, and it is important when new production facilities are being built that the chosen biomanufacturing technologies support this positive development, bringing high-quality biologics fast to market. We are excited to collaborate with Clover Biopharmaceuticals and to contribute to their promising and ambitious product pipeline by delivering a flexible, start-to-finish biomanufacturing platform based on single-use technologies,” said Sven Henrichwark, General Manager, Global Commercial BioProcess, GE Healthcare Life Sciences.
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For more on GE Healthcare’s FlexFactory platform, click here.
1. Source: IMS data, CMH data, internal modeling and analysis.