GE Partners in Single-Use Biomanufacturing for CAR-T Therapy
GE Healthcare has agreed to configure a biomanufacturing facility in Shanghai, China for Cellular Biomedicine Group (CBMG), a Shanghai-headquartered clinical-stage biopharmaceutical company focused on cancer immunotherapies and stem-cell therapies for degenerative diseases. GE will use its FlexFactory platform, a single-use biomanufacturing platform.
To allow for reproducible manufacturing of cell therapies, GE Healthcare developed FlexFactory for cell therapies as a scalable, semi-automated end-to-end platform for this application.
CBMG develops proprietary cell therapies for treating cancer and degenerative diseases. It conducts immuno-oncology and stem-cell clinical trials in China using products from its GMP laboratory. Its GMP facilities in China, consisting of 12 independent cell production lines, are designed and managed according to both China and US GMP standards. CBMG recently commenced two Phase I clinical trials in China using a chimeric antigen receptor T-cell (CAR-T) therapy to treat relapsed/refractory CD19+ B-cell acute lymphoblastic leukemia and refractory diffuse large B-cell lymphoma as well as an ongoing Phase I trial in China for AlloJoin, an allogeneic human adipose-derived mesenchymal stem cell therapy, for treating knee osteoarthritis.