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portada Potency Assays for Advanced Stem Cell Therapy Medicinal Products
Type
Physical Book
Publisher
Author
Collection
Advances in Experimental Medicine and Biology
Year
2024
Pages
214
Format
Paperback
Dimensions
25.4x17.8 cm
ISBN13
9783031300424

Potency Assays for Advanced Stem Cell Therapy Medicinal Products

Jorge S. Burns (Author) · Springer International Publishing AG · Paperback

Potency Assays for Advanced Stem Cell Therapy Medicinal Products - Jorge S. Burns

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Synopsis "Potency Assays for Advanced Stem Cell Therapy Medicinal Products"

The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potencyassay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval.

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