Stem Cell Manufacturing: Stem Cell–Based Products Aren’t Rolling Off Assembly Lines Yet

Stem Cell Manufacturing: It’s All about Scale

According to one forecast, the stem cell market will grow at an annual rate of 9.2% and attain a value of almost $16 billion by 2025. This prediction, from a 2017 study by Grand View Research, may not justify any career- or life-altering decisions—not by itself. It does correlate, however, with figures showing consistent growth in the volume of published research. Because these market research results and bibliometric figures support each other, their common implication—high year-on-year growth in the stem cell market—seems reasonably certain.

Much of the stem cell market’s growth comes from the development and manufacture of stem cell therapeutic products. In this segment, the challenge is—and always will be—manufacturing at scales commensurate with profitability.

“Stem cell processes involve many complex, open-process steps that are still largely unintegrated and manual,” notes Aaron Dulgar-Tulloch, Ph.D., director of cell therapy R&D at GE Healthcare. “This in turn contributes to high variability and operational costs, which increase risk and drive up cost of goods.”

Stem cell therapies, in particular, face the extraordinary challenge of producing from undifferentiated cells a product that is completely matured into the desired therapeutic cell lineage.

GE Healthcare’s involvement in stem cell production dates from the industry’s earliest days. In January 2016, GE Healthcare contributed to a $40 million investment in the Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM). Later that year, in April, GE Ventures teamed with the Mayo Clinic to launch Vitruvian Networks, which provides software for producers of cell-based therapies. A few months later, in August, GE Healthcare acquired the Biosafe Group, whose specialty was cell and cord blood bioprocessing.

In April 2017, GE Healthcare acquired Asymptote, a cryogenic processing company, and announced a partnership with the Cellular Biomedicine Group to develop chimeric antigen receptor T cell (CAR-T) and stem cell production technologies. In October 2017, the company opened its first 3D printing laboratory in Uppsala, Sweden. Thus, GE Healthcare thus covers quite a few bases in the cell therapy marketplace, in addition to maintaining its eminence in traditional bioprocessing.

With the increasing number of cell and gene therapies moving into mid- to late-stage clinical trials, observes Dr. Dulgar-Tulloch, “companies are challenged to improve their manufacturing process to minimize impact on their clinical development timeline and help ensure cost- and time-effectiveness.” Continue reading article

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