GE Healthcare said today that its FlexFactory™ single-use biomanufacturing platform has been selected by Clover Biopharmaceuticals, a Chinese developer of biologics, for its new facility located in Changxing, Zhejiang.
The new facility will primarily produce biological fusion protein products, including innovative drugs and biosimilars. The facility includes two 2000-liter bioreactors from GE, and will be operational in the latter half of 2018, Clover and GE Healthcare said.
SCB-808, a prefilled syringe formulation Enbrelâ (etanercept) biosimilar candidate indicated for the treatment of rheumatoid arthritis and other autoimmune diseases, will be the first therapeutic product to be produced at Clover’s facility using FlexFactory. On December 22, Clover won approval from the Chinese Food and Drug Administration (CFDA) to conduct clinical trials of SCB-808 in China, with a Phase I trial set to begin in mid 2018.
SCB-808 would be ready-for-injection and can potentially be self-administered by patients in the convenience of their own homes, according to Clover.
Clover produces novel, covalently-trimerized fusion proteins using its Trimer-Tag® drug development platform. The proteins are designed to attack trimerization-dependent disease targets, such as the tumor necrosis factor (TNF) superfamily, as well as enveloped RNA virus antigens responsible for entry into host cells.
Just eight days before receiving approval for the clinical trial, on December 14, Clover completed a RMB 62.8 million (approximately $9.8 million) Series A financing led by Tianhe Life Sciences Venture Fund.
Clover said proceeds would help fund development of SCB-808 as well as cancer candidate SCB-313, a novel fusion protein consisting of TRAIL (TNF-related apoptosis-inducing ligand) and Trimer-Tag that is set to begin clinical studies in Australia early this year.
New Biopharma Cluster
Clover’s production facility will be within China’s Changxing Economic and Technological Development Zone, where the world’s most populous nation is developing a new biopharmaceutical industrial cluster.
That cluster is being developed as part of China’s biotechnological innovation portion of the government’s 13th Five-Year Plan, which includes plans to build up to 20 science parks for biomedicine by 2020, with the aim of accelerating local research and development activities.
Clover and GE Healthcare cited figures pegging the value of China’s biopharmaceutical market at approximately $13 billion in 2015, with an estimated annual growth rate (CAGR) around 13%.
The companies said FlexFactory will help Clover Biopharmaceuticals bring biologic therapies to China faster, while also opening global markets through the platform’s ability to meet global regulatory requirements and quality standards.
“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,” Peng Liang, Ph.D., Clover’s co-founder, chairman, and president, said in a statement.
Clover is the second Chinese biopharma to disclose plans to install FlexFactory this month. Last week, Cellular Biomedicine Group (CBMG) said it would equip part of its Shanghai facility with the GE Healthcare platform, with the goal of speeding up manufacturing timelines for its cell therapy clinical trials and commercial launch.
Added Sven Henrichwark, general manager, Global Commercial BioProcess, GE Healthcare Life Sciences: “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.”
FlexFactory is a centrally automated, flexible biomanufacturing platform designed for production of biopharmaceuticals, with the goal of enabling manufacturers to quickly and easily establish biopharma manufacturing capacity within an existing building or as part of a new facility. FlexFactory is comprised of single-use technologies and associated process hardware as well as automation and control components intended for start-to-finish manufacturing of biopharmaceuticals.