GE Healthcare Life Sciences' FlexFactory™ Platform in Changxing, Zhejiang Officially Launched with First Product SCB-808

Changxing, Zhejiang, January 13, 2020 /PRNewswire/ -- On January 11, 2020, GE Healthcare Life Sciences announced the official completion and commencement of production of the FlexFactory™ manufacturing platform built for Clover Biopharmaceuticals. Currently equipped with two 2,000L production lines, the platform will help accelerate Clover Biopharmaceuticals’ innovative development. “SCB-808 Pre-filled Small Volume Injection,” a biosimilar for the treatment of rheumatoid arthritis and ankylosing spondylitis, became the first biopharmaceutical product manufactured on this platform.

Driven by a substantial surge in medical demand and robust support from government policies such as the “13th Five-Year Plan” for the Development of the Bioindustry, China’s biopharmaceutical industry is entering a phase of rapid and vigorous growth. In the face of a booming market environment and increasingly intense competition, a critical challenge for biopharmaceutical enterprises is to reduce production costs, enhance production efficiency, and accelerate the industrialization of innovative drugs while ensuring product quality, thereby securing a competitive edge in the market.

Yu Lihua, General Manager of Greater China for GE Healthcare’s Life Sciences division, stated, “We are delighted to join Clover Biopharmaceuticals in celebrating the launch of the FlexFactory production platform. As a long-term partner to Chinese biopharmaceutical companies, GE Healthcare Life Sciences remains committed to helping them enhance production capacity through cutting-edge technologies, comprehensive solutions, and robust services, ultimately enabling more patients to benefit from affordable, high-quality biologics.”

“Biopharmaceuticals represent an extremely complex systems engineering endeavor, requiring cutting-edge expertise for research, development, and manufacturing. Clover Biopharmaceuticals boasts a robust pipeline of innovative drugs and high-end biosimilars, among which SCB-808, a biosimilar for the treatment of rheumatoid arthritis and ankylosing spondylitis, has entered Phase III clinical trials in China,” stated Dr. Liang Peng, Founder, Chairman, and President of Clover Biopharmaceuticals. “We are delighted to establish a long-term partnership with GE HealthCare Life Sciences. The completion and official commencement of operations of the FlexFactory production platform today mark a new chapter in Clover’s corporate development. We believe that, leveraging the FlexFactory production platform solutions, we will accelerate the realization of Clover’s corporate vision—to bring more safe, effective, user-friendly, and affordable biopharmaceuticals to patients in China.””

GE HealthCare Life Sciences has developed a FlexFactory production platform solution for Clover Biopharmaceuticals, encompassing cGMP-compliant process technologies, integrated service packages, and training services to fully support its rapid growth. As a key FlexFactory flexible manufacturing project for GE HealthCare Life Sciences in Greater China, this NMPA- and FDA-compliant FlexFactory production platform is located in the Changxing Economic and Technological Development Zone, Huzhou City, Zhejiang Province. It is designed for the industrial-scale production of Clover Biopharmaceuticals’ biosimilars and innovative drugs, with the capacity to scale up production lines in response to future manufacturing demands.

Sven Frie, General Manager of Global Enterprise Solutions for the Life Sciences division of GE Healthcare, stated: “As R&D products enter clinical trial phases, manufacturers must race against time while continuously enhancing their production capabilities to ensure economic efficiency. Leveraging the FlexFactory production platform, GE Healthcare Life Sciences is committed to providing global biopharmaceutical companies with a modular, end-to-end solution spanning from cell culture to bulk fill-finish, thereby enabling our customers to achieve robust process scale-up and deliver therapies to patients more efficiently.”

GE HealthCare Life Sciences’ FlexFactory production platform is a modern biopharmaceutical manufacturing platform based on single-use, large-scale bioreactor serum-free cell culture technology with integrated control, enabling biopharmaceutical companies to rapidly achieve cGMP-compliant production capabilities. To date, GE HealthCare Life Sciences has provided the FlexFactory production platform to more than 11 biopharmaceutical companies in Greater China. Its single-use process equipment, flexible modular configuration, and highly integrated digital control significantly reduce upfront production and operational costs, accelerating product manufacturing and time-to-market.