China: Immunotherapy CBMG Announces Completion of Wuxi GMP Facility Expansion
Cellular Biomedicine Group, a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, announced the completion of its newly expanded 2,800 m2 facility in Huishan High Tech Park in Wuxi, China.
Shanghai/China — Two thirds of the Wuxi GMP facility will be dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents. By the end of 2017, the company anticipates that the combination of this Wuxi site, the new Zhangjiang Shanghai and the Beijing GMP facilities will be capable of supporting simultaneous clinical trials for five different Car-T and stem cell products, or capacity to treat up to 10,000 cancer and 10,000 Knee Osteoarthritis (KOA) patients per year.
“As we have previously stated, this marks a key milestone in our corporate development in the first quarter of 2017 as we continue to invest in and expand our capabilities in advanced CAR-T and stem cell manufacturing. We have long recognized the logistical challenges of delivering consistent, quality and clinical grade processes to deliver cell therapies to market and we have differentiated our capabilities to meet this challenge. We will now be able to centralize, standardize and automate our manufacturing capabilities fully in-house while enhancing our capacity to meet the production demands of multiple products in development as part of our overall Chemistry, Manufacturing, and Controls (“CMC”) process,” said Tony (Bizuo) Liu, Chief Executive Officer of Cellular Biomedicine Group.
“The Wuxi facility is equipped with six independent production lines and will be capable of producing and banking low endotoxin high transfection rate plasmids, and high titer automated and purified virus with stringent quality control,” commented Helen Zhang, SVP of Technology & Manufacturing for CBMG.
The biopharmaceutical firm recently commenced two Phase I human clinical trials in China using Car-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for Allojoin (CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis (KOA). The company was also recently awarded $ 2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of Allojoin for Knee Osteoarthritis in the United States.