January 13, 2020

FlexFactory™ bioprocessing platform completed in Changxing, China helps Clover industrialize new biopharmaceuticals

By GE Healthcare Life Sciences

GE Healthcare Life Sciences has put into operation its FlexFactory™ bioprocessing platform built for Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies. SCB-808, a prefilled syringe formulation of Enbrel® (etanercept) biosimilar candidate for the treatment of rheumatoid arthritis (RA) and ankylosing spondylitis (AS), is the first therapeutic product produced using this platform.

The platform is equipped with 2 x 2000L bioreactors, which can be further expanded according to future needs for the production of biopharmaceutical recombinant biosimilars and innovative drugs. It is expected to accelerate the process for Clover Biopharmaceuticals to bring local access to biologic therapies.

With rapid growth in medical demand and the strong support of relevant government policies including Thirteenth Five-Year Plan for the Development of Bio-industry, China's biopharmaceutical industry is ushering in a booming stage. In a fast-growing market and among fiercer competition, biopharmaceutical companies face challenges such as how to reduce production cost, improve production efficiency, and accelerate the industrialization of innovative drugs while maintaining product quality.

Lihua Yu, General Manager, Greater China, GE Healthcare Life Sciences Biopharma, said: “As a long-term partner of Chinese biopharmaceutical companies, GE Healthcare Life Sciences is committed to adopting cutting-edge technology, excellent integrated solutions and comprehensive services to help Chinese biopharmaceutical companies to increase production capacity and ultimately benefit more patients with affordable, high-quality biopharmaceuticals."

Dr. Peng Liang, Co-founder, Chairman and President of Clover Biopharmaceuticals, said: "Clover has a rich portfolio of novel biologics and biosimilars. The biosimilar SCB-808 for the treatment of rheumatoid arthritis, and SCB-313 for tumor treatment, have entered the clinical trial stage. I believe that with FlexFactory, we will accelerate the implementation of our vision - to bring safer, more effective, and more affordable biopharmaceuticals to Chinese patients."

The FlexFactory platform for Clover Biopharmaceuticals includes various process technologies which can be used in a cGMP-compliant way, integration and service packages, and training services to fully support its rapid development. This platform can be used in compliance with NMPA and FDA regulations and is located in Changxing Economic and Technological Development District, Huzhou, Zhejiang Province. It can be further expanded according to future needs for the production of biopharmaceutical recombinant biosimilars and innovative drugs.

Sven Frie, General Manager, Commercial Enterprise Solutions, GE Healthcare Life Sciences, said: "As biopharmaceuticals enter the clinical trial stage, manufacturers have to race against time, while continuously improving their production capability to ensure economic benefits. Our modular integrated solutions help our customers achieve stable maximized production process and provide more effective treatment for patients."

GE Healthcare Life Sciences’ FlexFactory platform is a modern biopharmaceutical bioprocessing platform based on single-use large-scale bioreactor serum-free cell culture technology and integrated control systems, which can help biopharmaceutical companies quickly obtain cGMP production capabilities. GE Healthcare Life Sciences has to date provided FlexFactory platforms to 11 biopharmaceutical companies in the Greater China area. Its single-use process equipment, flexible modular configuration and highly integrated digital control system can greatly reduce the early production and operating costs of enterprises and accelerate the production and listing process of products.

About GE Healthcare Life Sciences

GE Healthcare Life Sciences helps therapy innovators, researchers and healthcare providers faster invented, made and used precision diagnostics and therapies. Our products enable biological analysis, research, development and the manufacture of advanced therapies and vaccines. Life Sciences is part of the $19.8 billion healthcare business of GE (NYSE: GE). With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, GE Healthcare helps efficiently improve outcomes for patients, healthcare providers, researchers, and life sciences companies around the world. Visit our website for more information.

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 our website: www.cloverbiopharma.com.

Media Contacts