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Measuring the Potency of a Stem Cell Therapeutic

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Stem Cell Protocols

Part of the book series: Methods in Molecular Biology ((MIMB,volume 1235))

Abstract

The potency of a drug is one of the most important parameters of a therapeutic. Besides providing the basis for manufacturing consistency and product stability, the potency can predict product failure or toxicity due to incorrect potency, provide release criteria, and the dose that will ensure that it can be used as intended. Recently, cellular therapeutics, in particular, stem cell therapy products, have being designated as “drugs” by regulatory agencies if they produce a systemic effect in the patient. Regulatory agencies are becoming increasingly stringent with respect to the manufacture, production, and testing of these products prior to being used in a patient. A clear understanding of what potency is and how it can be measured should help erase the misunderstandings and misconceptions that have accrued within the cellular therapy field. This protocol describes how the potency of hematopoietic stem cell therapy products is determined. The same principles apply to any proliferating stem cell therapeutic product.

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Correspondence to Ivan N. Rich .

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Harper, H., Rich, I.N. (2015). Measuring the Potency of a Stem Cell Therapeutic. In: Rich, I. (eds) Stem Cell Protocols. Methods in Molecular Biology, vol 1235. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-1785-3_4

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  • DOI: https://doi.org/10.1007/978-1-4939-1785-3_4

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-1784-6

  • Online ISBN: 978-1-4939-1785-3

  • eBook Packages: Springer Protocols

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