One of the biggest hurdles to commercialization of stem cell-based therapies is the manufacture, under closed and sterile conditions, of validated stem cell products. Much has been said, on this blog and elsewhere, of the various guidances issued by the FDA that touch on the manufacture of stem cell-based products. Standardization agencies have invested significant effort in consolidating manufacturing processes and efforts at harmonization are consistently under way.
Various automated, single-unit systems have appeared on the market – some more sophisticated than others. Most of these closed systems, however, still rely on significant user input.
One new initiative, backed by the European Union, is called AUTOSTEM, and brings together a consortium of academic institution alongside industrial and EU support to create a fully automated stem cell production platform.
In their own words:
AUTOSTEM is an EU H2020 project that is developing a closed, automated, sterile pipeline for large scale production of therapeutic stem cells. It will enable lower-cost, higher-quality and more consistent stem cells to be produced, ultimately helping patients to benefit from new stem cell therapies.
The project, which is led by Dr Mary Murphy of the National University of Ireland, Galway, brings together a consortium of companies and academic institutions, including the Fraunhofer Institute for Production Technology (IPT) in Aachen, the University of Cork in Ireland and UK’s Cell Therapy Catapult.
The entire stem cell production process involves no hands-on human operations. In a recent paper, published in Regenerative Medicine, by Dr. Mary Murphy at the Regenerative Medicine Institute School of Medicine at the National University of Ireland, and colleagues involved in the AUTOSTEM project, discusses the initiative, describing it as a breakthrough way to achieve large scale hMSC production at clinical grade.
This project is backed by funding from the European Union’s Horizon 2020 research and innovation program.
Similar initiatives exist closer to home. The New York Stem Cell Foundation is developing the Global Stem Cell Array, a new technology platform for the production of induced pluripotent stem cell lines in a parallel automated process. This enables the standardization to be achieved through automation of the manufacturing process. The researchers involved in the project published a paper last year in Nature Methods which gives more details on the initiative.
These efforts are the first steps – though not the only ones – to achieving automation of large scale manufacture of stem cells, which will be increasingly more critical are new therapies mature to commercial stage.
To support these new systems, more sophisticated solutions – from ancillary materials to full scale validation controls – will have to be in place in order to shift the paradigm from the current highly laborious and poorly controlled landscape to one of compliance, quality and therapeutic efficacy.