At the Clover Biopharmaceuticals site, biomanufacturing technologies will include two 2,000L lines, which president Peng Liang said will “help us establish flexible production capacity quickly, while fulfilling good manufacturing practices (GMP) requirements.”
The facility is expected to be operational in the second half of 2018.
Liang said the first therapeutic product to be made using the FlexFactory platform is SCB-808, a prefilled syringe formulation of Amgen’s Enbrel (etanercept) indicated 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,” said Liang.
Last month, Clover Biopharmaceuticals announced had received Clinical Trial Application (CTA) approval from the Chinese Food and Drug Administration (CFDA) to conduct clinical trials in China with SCB-808. A Phase I clinical trial is planned in China for mid-2018.
FlexFactory in China
GE executive Sven Henrichwark said the firm has installed more than 20 FlexFactory fit outs around the world, with China being one of the largest markets for this technology.
In 2015, BeiGene selected the FlexFactory for its monoclonal antibody (mAb) plant in Suzhou, and earlier this month Cellular Biomedicine Group (CBMG) announced it had adopted the technology for CAR-T therapy production at its production facility in Shanghai.
Despite increased adoption rates, neither firm is concerned about the protection of intellectual property.
“The rapid growth of the Chinese biopharmaceutical industry is positive, and GE is convinced that intellectual property (IP) for this platform is protected and respected by the biopharma industry in China,” Clover spokesperson Jane Wu told us.
Henrichward told us “GE has been working in China for over 100 years…We feel confident that intellectual property (IP) is protected by all parties involved.”