Illustrative Potency Assay Examples from Approved Therapies

• Published in: Advances in experimental medicine and biology Vol. 1420; p. 139
• Main Authors: Torrents, Sílvia, Grau-Vorster, Marta, Vives, Joaquim
• Format: Journal Article
• Language: English
• Published: United States 01.01.2023
• Subjects: CAR T-cell therapy; Compliance; Tissue engineering; Immunotherapy; Cell therapies; Epithelial stem cells; Gene therapies; CAR T-cell potency; Approved ATMP; Hematopoietic stem cells

Advanced therapy medicinal products (ATMP) encompass a new type of drugs resulting from the manipulation of genes, cells, and tissues to generate innovative medicinal entities with tailored pharmaceutical activity. Definition of suitable potency tests for product release are challenging in this cont...