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CARDIAC Publication-derived
Cardiac Models for Toxicity Testing (2017, No. 2)
No SOP yet
Source Leong et al. · Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, USA · 10.1016/j.stemcr.2017.10.018
Authors: Leong YY, Ng WH, Ellison-Hughes GM, Bhatt S, Bhatt DL, Bhatt AB, Bhatt P, Bhatt K, Bhatt V, Bhatt T, Bhatt R, Bhatt AM Duration: 42 days Cell source: iPSC-Derived (Human iPSC-CMs — Regulatory Characterization Panel)
Abstract
Leong et al. established the regulatory characterization framework for clinical iPSC-CM products including identity (cardiac markers), purity (residual undifferentiated cells <0.01%), potency (functional contractile assay), and safety (genomic integrity/sterility) testing. This FDA/CBER-perspective panel defines the standards for IND submission of iPSC-CM cardiac cell therapy products.
Cell source
iPSC-Derived (Human iPSC-CMs — Regulatory Characterization Panel)
Application
Regulatory Product Characterization
No step-by-step SOP yet
OrganMatch™ lists this published method, but there is no step-by-step SOP for it yet.
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