Evaluation of the reproducibility and positive controls of cellular immortality test for the detection of immortalized cellular impurities in human cell-processed therapeutic products

Takamasa Hirai,Ken Kono,Shinji Kusakawa,Satoshi Yasuda,Rumi Sawada, Akihiko Morishita,Shinko Hata,Atsushi Wakita, Takayasu Kageyama, Ryo Takahashi, Sono Watanabe, Norihiko Shiraishi,Yoji Sato

Regenerative Therapy（2022）

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摘要

•Cellular immortality test was reproducible across laboratories.•Contaminations with immortalized cells were detectable regardless of tumorigenicity.•Detection sensitivity was dependent on cell type and number of cellular impurities.

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关键词

Cellular immortality test,Cell growth analysis,Cellular therapy,Tumorigenicity,Quality and safety

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