What is an acceptable cell viability for cell therapy products?
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Quick answer
For cell therapy products, the FDA generally expects a minimum viability specification above 70%, and sponsors must justify a lower limit with data [2]. NK-cell trials in the US and Europe used ≥70% across the board [4]. Some products use stricter limits. The commercial specification for the CAR T product tisagenlecleucel is at least 80%, although a 2019 analysis found no link between viability below 80% and remission rates [3].
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Sources
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