Cellular Biomedicine Group, a specialist clinical-stage biopharmaceutical firm, engaged in the development of immunotherapies for cancer, has announced its plan to configure part of its facility in Shanghai with GE Healthcare’s FlexFactory platform, which will be designed to speed up manufacturing timelines for its cell therapy clinical trials and commercial launch.
There are more than 900 regenerative medicine trials underway globally, including trials in cell and gene therapy, a 19% 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 commercialisation have been limited.
Many of the multiple cell therapy manufacturing process steps remain largely unintegrated and manual, with open transfers between steps increasing contamination risk.2
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.
From start to finish, the process of getting a lab ready for optimised industrial-scale manufacturing would typically take a cell therapy manufacturer more than 18 months to complete.
FlexFactory can reduce this time by up to 50%, getting a company ready to manufacture at scale nine months faster, ultimately accelerating time to market and enabling clinicians to deliver therapies to patients sooner.
Following the execution of this non-binding letter of intent (LOI), CBMG will become the first company to install GE’s FlexFactory for cell therapy and anticipates that the FlexFactory 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 space — this new generation of semi-automated and standardised 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 utilise digital technology, semi-automation and analytics, in an effort to reduce overall costs and deliver treatments to patients more efficiently,” said Tony Liu, CEO, CBMG.
GE Healthcare’s FlexFactory solution will 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 commercialising 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 industrialisation, 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.
Through its collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM), a leader in developing and commercialising 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 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 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 industrialise 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 commercialise its CAR T-cell therapy to treat patients with various blood and solid tumor cancers,” said Michael May, President and CEO, CCRM.
References
- ARM 2018 State of the Industry: https://alliancerm.org/sites/default/files/ARM_SOTI_2018_FINAL.pdf
- The typical cell therapy manufacturing workflow includes controlled product thaw, isolation, activation, expansion, harvest, final formulation, and cryopreservation.