Potency Assays for Advanced Stem Cell Therapy Medicinal Products
2023 ed.
Book Details
Format
Paperback / Softback
Book Series
Advances in Experimental Medicine and Biology
ISBN-10
3031300424
ISBN-13
9783031300424
Edition
2023 ed.
Publisher
Springer International Publishing AG
Imprint
Springer International Publishing AG
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Jun 19th, 2024
Print length
214 Pages
Product Classification:
Medical microbiology & virologyDevelopmental biologyBiotechnology
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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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