Stem cell therapies may need new protein quality control standards
Current Good Manufacturing Practice (GMP) standards for cell therapies assess identity, viability, sterility, and genetic stability. For extracellular vesicle (EV) products, Minimal Information for Studies of Extracellular Vesicles (MISEV2023) guidance adds particle size, concentration, markers, morphology, contaminants, endotoxin, and assays.
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