On November 6, 2017 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a leading clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and effective stem cell therapies for degenerative diseases, reported the establishment of a strategic partnership with Thermo Fisher Scientific (China) Ltd. (Thermo Fisher) to build a joint Cell Therapy Technology Innovation and Application Center (Center) at CBMG’s newly opened Shanghai Zhangjiang GMP facility (Press release, Cellular Biomedicine Group, NOV 6, 2017, View Source [SID1234521571]). The Center is named "CBMG-Thermo Fisher Scientific Joint Innovation & Application Center". The partnership focuses on the research and development of an automated cell therapy manufacturing system.
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"Break-through cell therapy technology such as CAR-T provides unprecedented medical needs to cancer patients, yet the successful commercialization of this technology will require robust logistics, manufacturing and complex management systems," commented Tony (Bizuo) Liu, CEO of CBMG. "When we combine Thermo Fisher’s strengths in biopharmaceutical products and manufacturing quality control processes with CBMG’s vertically integrated cell therapy manufacturing system, we believe we can further increase productivity, reduce cost, improve batch stability, reduce variability and institutionalize the Chemistry, Manufacturing, and Controls (CMC) processes, which we believe will help to address some of the primary logistical challenges faced by the CAR-T cell therapy industry. We are optimistic that this partnership will not only bring mutual benefit to CBMG and Thermo Fisher, but also to the cell therapy industry sector as a whole."
"This cooperation demonstrates our commitment to China. As a world leader in serving science, Thermo Fisher seeks to provide total solutions for cell therapy research, development, and manufacturing. We believe this will help to accelerate the development of the cell therapy industry in China. Based on our broad product portfolio, Thermo Fisher has developed outstanding capabilities in global CAR-T manufacturing, including our Cell Therapy Systems (CTS) Dynabeads technology in the first FDA-approved cell therapy." said Gianluca Pettiti, President of Thermo Fisher China, "We look forward to this strategic partnership and the benefits that the Joint Innovation and Application Center will provide to a vast Chinese patient population."
CBMG’s new Zhangjiang facility, together with an expanded Wuxi and Beijing GMP facilities combined, comprises 70,000 square feet for development and production. This will enable CBMG to conduct simultaneous clinical trials for multiple CAR-T and stem cell product candidates. At full production volumes, these facilities could support treating 10,000 cancer patients and 10,000 Knee Osteoarthritis patients per year. The Company’s combined GMP expansion will enable scaled-up supply for current and future CAR-T clinical trials and streamline efficiency from R&D into manufacturing of CAR-T cells for clinical use, IND filings and future commercialization. The Company currently has ongoing CAR-T Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL) and CALL-1 for adult Acute Lymphoblastic Leukemia (ALL), utilizing CBMG’s proprietary and optimized CD19 construct.