Cost-Effective Master Cell Bank Validation of Multiple Clinical-Grade Human Pluripotent Stem Cell Lines From a Single Donor

摘要: Standardization guidelines for human pluripotent stem cells are still very broadly defined, despite ongoing clinical trials in the U.S., U.K., and Japan. The requirements validation of embryonic (hESCs) induced (iPSCs) general follow regulations other clinically compliant biologics already place but without addressing key differences between cell types or final products. In order to realize full potential therapy, criteria, methodology, and, most importantly, strategy, should address shortfalls efficiency current approaches; this, hESC- especially, iPSC-based therapy will not be able compete with technologies a cost-efficient way. We addressed protocols testing lines viral pathogens propose novel strategy that would significantly reduce costs. It is highly unlikely multiple derived parallel from tissue sample taken one donor have different profiles endogenous pathogens; we therefore argue samples Master Cell Banks sibling could safely pooled validation. illustrate this approach tiered two clinical-grade hESC lines, KCL033 KCL034 (stage 1, sterility; stage 2, specific 3, nonspecific pathogens). results all tests were negative. This cost-effective also applied iPSC single donor.