Cellular Biomedicine Group (CBMG) plans to equip part of its Shanghai facility with GE Healthcare’s FlexFactory™ platform. The goal is to accelerate manufacturing timelines for its cell therapy clinical trials and commercial launch.
The process of getting a lab ready for optimized industrial-scale manufacturing would typically take a cell therapy manufacturer over 18 months to complete, according to Ger Brophy, Ph.D., general manager, Cell Therapy, GE Healthcare Life Sciences. FlexFactory can reduce this time by up to 50%, getting a company ready to manufacture at scale nine months faster, he says.
CBMG will become the first company to install GE’s FlexFactory for cell therapy and anticipates that the FlexFactory will be up and running in the CBMG-GE Joint Laboratory of Cell Therapy by the end of 2018.
Brophy adds that GE is collaborating with the Centre for Commercialization of Regenerative Medicine (CCRM), a Canadian not-for-profit organization. The combined GE and CCRM process development team will support CBMG in increasing process efficiency by establishing a robust process development effort focused on simplifying, integrating, and automating the manufacturing workflow, notes Brophy.
CBMG will use its FlexFactory for commercializing CAR T-cell therapies, targeting various blood and solid tumor cancers.
“This is a productivity revolution in the CAR-T space. This new generation of semiautomated 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, semiautomation, and analytics, in an effort to reduce overall costs and deliver treatments to patients more efficiently,” says Tony (Bizuo) Liu, CEO, CBMG.
Daria Donati, director, Business Development and Innovation Enterprise Solutions, GE Healthcare Life Sciences, sees the FlexFactory as representing a major trend in biomanufacturing.
“When you consider manufacturing capacity, you think about two major elements: the facility itself and then the processing technology. There is a trend today toward smaller facilities and a smaller footprint, thus reducing the cost of the investment,” she tells GEN. “Companies also are interested in adding facilities that allow them to move on from manufacturing one product to another as flexibly as possible.”