AsianScientist (Apr. 6, 2017) – Cellular Biomedicine Group Inc. (CBMG), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, has completed a newly expanded facility in Huishan High Tech Park in Wuxi, China.
Of the total 30,000 square feet of the good manufacturing practice (GMP) facility, 20,000 square feet will be dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents.
“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,” added Ms. Helen Zhang, Senior Vice President of Technology & Manufacturing for CBMG.
CBMG recently commenced two Phase I human clinical trials in China using chimeric antigen receptor T cells (CAR-T) to treat relapsed or 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 AlloJoinTM, CBMG’s “Off-the-Shelf” allogeneic human adipose-derived mesenchymal stem cell for the treatment of knee osteoarthritis.
CBMG was also recently awarded US$2.29 million from the California Institute for Regenerative Medicine to support pre-clinical studies of AlloJoinTM for knee osteoarthritis in the United States.
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 patients per year.
“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,” said Mr. Tony (Bizuo) Liu, Chief Executive Officer of CBMG.
“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 process.”
———
Source: Cellular Biomedicine Group Inc.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.
