Streamlining Stem Cell Manufacturing

The Factory System Will Help the Stem Cell Industry Standardize, Integrate, and Automate Unit Operations

Stem cell therapies hold extraordinary potential to revolutionize human medicine. Indeed, the global market for cell-based therapies is expected to surpass $20 billion by 2025, with an annual growth rate of 21%, as estimated by Scientia Advisors. Because stem cells have the ability to transform into a variety of cell types, stem cell therapeutic targets include cancer, neurodegenerative disease, heart disease, autoimmune disease, and musculoskeletal disorders.

The choice of which stem cells to pursue for clinical applications depends both on their potential clinical risks and accessibility. Stem cells can be isolated from many sources. For example, multipotent adult mesenchymal stem cells (MSCs) are readily harvested from the bone marrow of patients or donors for use in autologous or allogeneic therapies. MSCs can also be derived from blood, fat, placental and umbilical tissue, and other tissues.

Stem cells of another type, pluripotent stem cells (PSCs), are isolated from preimplantation embryos. Also, somatic cells may be coaxed to return to a more primitive state, and become induced pluripotent stem cells (iPSCs), through the application of specific transcription factors.

Various ways of developing therapeutic stem cells are of interest to stem cell manufacturers, who hope to make large-scale production of stem cells more efficient and economical. Production issues, as well as basic biology and application possibilities, were discussed at the Stem Cell Product Development and Commercialization Conference, a recent event that took place in Boston and was organized by GTCbio.

Stem cell specifics addressed at the event included the necessity of developing more cost-effective manufacturing solutions, ranging from altering media formulations and vessel types to utilizing automated, closed systems in place of traditional cleanrooms. Other solutions described newly available plug-and-play systems for rapid cell expansion and included advice for when to consider outsourcing processes to knowledgeable partner.

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