Defining Safety and Efficacy Through Rigorous Quality Assurance and Release Criteria
Ensuring the safety and efficacy of Mesenchymal Stem Cell products mandates stringent Quality Assurance protocols and comprehensive final product release criteria. Beyond the basic ISCT criteria for cell identity and a high threshold for cell viability (typically $>70\%$ or even $>90\%$), release testing is divided into critical safety, purity, and potency assays. Safety testing includes...
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