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Best Practices for Tissue Sourcing and iPSC Generation in Biomedical Research

This document outlines critical considerations in tissue sourcing and induced pluripotent stem cell (iPSC) generation. Key points include obtaining informed consent for tissue sourcing, necessary approvals for iPSC licensing (e.g., iPS Academia Japan, Inc.), and the selection of appropriate vectors, such as episomal plasmids or integration-free methods. The engineering of cells using open-source TALENs versus licensed technology is discussed, along with processing differentiated cells and acquiring necessary licenses for cell delivery devices and PSC-derived product manufacturing, encompassing preclinical and clinical study requirements.

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Best Practices for Tissue Sourcing and iPSC Generation in Biomedical Research

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  1. Tissue Sourcing ENGI NEERI NG • BASIC PROCESS CONSIDERATIONS • Tissue Sourcing: obtain informed consent • iPSC generation: approval of license • (ie. iPS Academia Japan, Inc) • Vectors: use episomal plasmids or • integration-free methods • Engineering: use open source TALENs or • license technology • Processing differentiated cells: acquire • license • Delivery Method: device to inject cells • PSC derivation SORT ING • PSC derived product manufacture • PSC Differentiation • Preclinical studies • Cells in Assay format • Clinical studies • Appropriate Screen • BMLA license and commercialization • Commercial Partner

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