GE Healthcare to Equip Cell Therapy Manufacturing Facility with Single-Use Platform

GE Healthcare will equip Cellular Biomedicine Group's (CBMG) cell therapy manufacturing facility in Shanghai, China, with its FlexFactory platform, a bioprocess platform using predominantly single-use technology, GE Healthcare announced on Jan. 18, 2018. CBMG, a clinical-stage biopharmaceutical firm focused on immunotherapies for cancer, plans to configure part of its Shanghai facility with the FlexFactory platform, which will be designed to speed up manufacturing timelines for its cell therapy clinical trials and commercial launch.

Despite an increasing number of precision medicine trials underway globally, including trials in cell and gene therapy, gaps exist in manufacturing these therapies to meet demand. In addition, scalable integrated solutions to support the transition from clinical trials to commercial manufacturing have been limited, GE Healthcare said in a company press release. Many of the multiple steps in the cell therapy manufacturing process are still largely unintegrated and require manual labor, according to the company. In addition, open transfers between steps increase the risk of contamination.

GE Healthcare therefore developed FlexFactory for cell therapy manufacturing to address the challenges in current precision medicine bioprocessing and to allow for reproducible manufacturing of cell therapies in particular. The technology provides a scalable, semi-automated end-to-end biomanufacturing platform.

The FlexFactory technology can reduce the time it takes to ready a lab for optimized industrial-scale manufacturing by up to 50%. Typically, this process takes over 18 months to complete from start to finish, according to GE Healthcare. CBMG will become the first company to install GE Healthcare's FlexFactory for cell therapy and anticipates that the platform will be operational in the CBMG-GE joint laboratory of cell therapy by the end of 2018.

"This is a productivity revolution in the CAR-T [chimeric antigen receptor T-cell] 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, CEO, CBMG, in a company press release.

Process development and training services

GE Healthcare will provide CBMG with 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 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 critical it is for companies to scale out manufacturing process capabilities, while still meeting clinical development timelines and remaining cost effective. We are committed to collaborating with cell therapy manufacturers on their journey from trials to industrialization, as they look to ultimately deliver these groundbreaking therapies to thousands of patients around the world," said Ger Brophy, general manager, Cell Therapy, GE Healthcare Life Sciences, in the press release.

Through a collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM), a Canadian not-for-profit organization developing and commercializing regenerative medicine technologies and cell and gene therapies, GE Healthcare is providing CBMG with process development services. The combined GE and CCRM process development team consists of 35 scientists and engineers with expertise in advanced therapeutic cell technologies, which will help bridge the gap between research protocols and industrial manufacturing. Together, GE and CCRM will 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, in the company press release.

Source: GE Healthcare