On January 18, 2018 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (CBMG or the Company), a leading clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer, reported its plan to configure part of its facility in Shanghai with GE Healthcare’s FlexFactory platform, which is expected to be designed to speed up manufacturing timelines for its cell therapy clinical trials and commercial launch (Press release, Cellular Biomedicine Group, JAN 18, 2018, View Source [SID1234523290]).
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There are more than 900 regenerative medicine trials underway globally, including trials in cell and gene therapy, a 19 percent increase since 2016.[1] Despite the increased number of precision medicine trials, gaps exist in how to manufacture these precise therapies to meet demand. Scalable integrated solutions to support the transition from clinical trials to commercialization have been limited. Many of the multiple cell therapy manufacturing process steps[2] remain largely unintegrated and manual, with open transfers between steps increasing contamination risk. To address these challenges and allow for reproducible manufacturing of cell therapies, GE Healthcare has developed FlexFactory for cell therapy, a scalable, semi-automated end-to-end platform.
"This is a productivity revolution in the CAR-T space – this new generation of semi-automated and standardized CAR-T manufacturing capabilities created by GE Healthcare and CBMG may allow cell therapy to provide an optimal platform and opportunity for general oncology patients. This long-term collaboration with GE could help us utilize digital technology, semi-automation and analytics, in an effort to reduce overall costs, and deliver treatments to patients more efficiently," said Tony (Bizuo) Liu, Chief Executive Officer, CBMG. GE Healthcare’s FlexFactory solution would support CBMG by providing process development and training services, cell processing equipment, semi-automation capabilities, and digital connectivity solutions – all of which support current good manufacturing practices (cGMP)-compliant manufacturing. CBMG plans to use its FlexFactory to speed up its timelines for commercializing its CAR T-cell therapies, targeting various blood and solid tumor cancers.
"With the rate in which cell therapies are moving through clinical trials, we understand how critentre for Commercialization of Regenerative Medicine (CCRM), a leader in developing and commercializing regenerative medicine technologies and cell and gene therapies, GE Healthcare expects to provide CBMG with process development services. The combined GE and CCRM process development team is comprised of 35 scientists and engineers with expertise in advanced therapeutic cell technologies, helping bridge the gap between research protocols and industrial manufacturing. GE and CCRM expects to support CBMG in increasing process efficiency by establishing a robust process development effort focused on simplifying, integrating and automating the manufacturing workflow.
"CCRM and GE Healthcare established the Centre for Advanced Therapeutic Cell Technologies, or CATCT, to industrialize cell manufacturing and accelerate the efforts of companies working with cell and gene therapies. The partnership between CBMG and GE is an exciting opportunity for the team at CCRM to demonstrate its process development skills and knowledge in overcoming cell therapy production challenges. We look forward to enabling CBMG in its efforts to commercialize its CAR T-cell therapy to treat patients with various blood and solid tumor cancers," said Michael May, President and CEO, CCRM.