Farid, SS; Jenkins, MJ; (2018) Bioprocesses for Cell Therapies. In: Jagschies, G and Lindskog, E and Galliher, P, (eds.) Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes. (pp. 899-930). Elsevier: Amsterdam, Netherlands.

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Abstract

Cell therapies have opened fresh avenues in modern medicine that have the potential to revolutionize healthcare. As of 2015, there were 1342 active clinical trials investigating the use of cell therapies. Cell therapies have applications in a range of medicinal fields, including treatment of stroke, age-related blindness (including macular degeneration), and a variety of cancers. Annual cell therapy revenues are in excess of US $1 billion, and are forecasted to be at least US $10 billion by 2021. If cell therapies are to achieve their full clinical and commercial potential, significant challenges must be overcome with regards to current abilities to produce clinical grade cells at commercially relevant scales. This chapter will cover bioprocess techniques associated with three distinct groups of cells with a variety of clinical applications: pluripotent stem cells (PSCs), mesenchymal stem cells (MSCs), and genetically engineered T-cells, known as chimeric antigen receptor (CAR) T-cells. Factors influencing key cost metrics, namely capital investment and cost of goods associated with cell therapy manufacturing are also introduced and discussed.

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