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CBMG To Use GE Healthcare Solution To Speed Cell Therapy Manufacturing.

SHANGHAI, China, and CUPERTINO, Calif., January 18, 2018 -- Cellular Biomedicine Group Inc. (CBMG), said it will configure part of its facility in Shanghai with GE Healthcare's FlexFactory platform, which could speed up manufacturing timelines for its cell therapy clinical trials and commercial launch.

CBMG has signed a nonbinding letter of intent regarding the use of GE Healthcare's platform.

More than 900 regenerative medicine trials are underway globally, including trials in cell and gene therapy, a 19 percent increase since 2016.

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 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.

From start to finish, the process of getting a lab ready for optimized industrial-scale manufacturing normally takes a cell therapy manufacturer 18 months to complete.

FlexFactory can reduce this time in half, 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.

CBMG expects to 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.

The 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.

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.

CBMG develops proprietary cell therapies for the treatment of cancer and degenerative diseases.

CCRM is a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and academic and industry partners. It supports the development and commercialization of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy.



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Title Annotation:Cell Manufacturing
Publication:Stem Cell Research News
Geographic Code:9CHIN
Date:Jan 29, 2018
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