CARDIAC Publication-derived

CM Clinical Products

Source Leong et al. · Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, USA · 10.1016/j.stemcr.2017.10.018

👤 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 ⏱ 20160 min 🧫 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

Full SOP

🔬

Create a free account to access this protocol

Join OrganMatch to unlock step-by-step procedures, reagent concentrations, QC checklists, and downloadable batch record templates.

Create free account

Already registered? Log in

Attribution

This SOP was authored by Organthis based on the published method in Leong et al.. The originating laboratory holds no rights in this SOP and has not endorsed it unless marked Verified.

This wording is awaiting legal review.

Something wrong with this entry? Report an issue with this protocol

Need a commercial licence?

Use this protocol in your therapeutic or diagnostic pipeline.

Request Commercial Licence