Cellular Biomedicine Group Inc. (CBMG), a leading 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 Cytiva’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 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, Cytiva 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 optimized industrial-scale manufacturing would typically take a cell therapy manufacturer over 18 months to complete. FlexFactory can reduce this time by up to 50 percent, 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 Cytiva's FlexFactory for cell therapy, and anticipates that the FlexFactory will be operational in the CBMG-Cytiva 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 standardized CAR-T manufacturing capabilities created by Cytiva and CBMG will allow cell therapy to provide an optimal platform and opportunity for general oncology patients. This long-term collaboration with Cytiva 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.
Cytiva’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 commercializing its CAR T-cell therapies, targeting various blood and solid tumor cancers.
Through its collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM), a leader in developing and commercializing regenerative medicine technologies and cell and gene therapies, Cytiva is providing CBMG with process development services. The combined Cytiva and CCRM process development team is comprises 35 scientists and engineers with expertise in advanced therapeutic cell technologies, helping bridge the gap between research protocols and industrial manufacturing. Cytiva 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.
To read the full press announcement, click here.
Learn more about Cytiva’s Cell Therapy Enterprise Solutions here.
1. ARM 2018 State of the Industry
2. The typical cell therapy manufacturing workflow includes controlled product thaw, isolation, activation, expansion, harvest, final formulation, and cryopreservation.