The new facility will support a robust pipeline of biopharmaceuticals, including a biosimilar to Enbrel® for the treatment of rheumatoid arthritis
Clover Biopharmaceuticals selects GE’s FlexFactory biomanufacturing platform for its new production facility in China
January 22, 2018
Chalfont St Giles, UK and Changxing, Zhejiang, China – 23 January 2018 — 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 2,000 liter bioreactors from GE, and it will be operational in the latter half of 2018.
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).
“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.”
“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.
(1) Source: IMS data, CMH data, internal modeling and analysis
GE Healthcare’s FlexFactory is a centrally automated, flexible biomanufacturing platform for the production of biopharmaceuticals, such as monoclonal antibodies and vaccines. It allows manufacturers to quickly and easily establish biopharmaceutical manufacturing capacity within an existing building or as part of a new facility. Designed to help manufacturers such as Clover Biopharmaceuticals to rapidly respond to local healthcare needs and to support global customers in bringing lifesaving treatments to market more quickly, FlexFactory is comprised of single-use technologies and associated process hardware as well as all necessary automation and control components for start-to-finish manufacturing of biopharmaceuticals.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases. Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. Additionally, Clover is leveraging its in-house cGMP biomanufacturing capabilities to develop select biosimilars. For more information, please visit Clover’s website: www.cloverbiopharma.com.
About GE Healthcare
Harnessing data and analytics across hardware, software and biotech, GE Healthcare is the $18 billion healthcare business of GE (NYSE: GE). As a leading provider of medical imaging equipment, with a track record of more than 100 years in the industry and more than 50,000 employees across 100 countries, we transform healthcare by delivering better outcomes for providers and patients. Follow us on Facebook, LinkedIn, and Twitter or The Pulse for latest news.