With the evolution of biological and biomedical research, the safety and stability of mammalian cells should be rigorously controlled, especially when used in the extended applications in both scientific and clinical fields such as disease modeling, preclinical research, bioproduction, industry, and precision medicine. In scientific research, the quality of cells has a major impact on the integrity and reproducibility of research. However, in recent years, the widespread and unrecognized use of misidentified cell lines has become a serious problem in scientific research, that these cell lines have been cross-contaminated, mislabeled, or even replaced. A report in 2015 suggests that 32,755 studies has used misidentified cell lines and been cited in 0.5 million papers[1], and severe cell line problems lead to rejection of 4% manuscripts[2], [3]. In 2010, the International Journal of Cancer requires and views the authentication of all human cell lines used in a manuscript[3]. Since 2015, Nature has asked authors to check the known misidentified cell lines and supported details of cell identify and mycoplasma testing[4].
Advanced techniques in cell engineering enables cell working as the factory to produce vectors and recombinant proteins which then used in therapeutic strategies, and in contrast, immune cells are cultured or engineering as anti ageing and anti-cancer treatments. FDA “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products” both recommend the utilization of qualified cell bank to ensure the safety, identity, purity, and stability of the cells in manufacturing process[5], [6].
If you would like to know more about cell banking, please feel free to contact us.
[1] S. P. J. M. Horbach and W. Halffman, “The ghosts of HeLa: How cell line misidentification contaminates the scientific literature,” PLOS ONE, vol. 12, no. 10, p. e0186281, Oct. 2017, doi: 10.1371/journal.pone.0186281.
[2] N. Y. Souren et al., “Cell line authentication: a necessity for reproducible biomedical research,” EMBO J., vol. 41, no. 14, p. e111307, July 2022, doi: 10.15252/embj.2022111307.
[3] S. Heck, F. Bianchini, N. Y. Souren, C. Wilhelm, Y. Ohl, and C. Plass, “Fake data, paper mills, and their authors: The International Journal of Cancer reacts to this threat to scientific integrity,” Int. J. Cancer, vol. 149, no. 3, pp. 492–493, Aug. 2021, doi: 10.1002/ijc.33604.
[4] “Announcement: Time to tackle cells’ mistaken identity,” Nature, vol. 520, no. 7547, pp. 264–264, Apr. 2015, doi: 10.1038/520264a.
[5] “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” Food and Drug Administration, Jan. 2024.
[6] “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).” Food and Drug Administration, Jan. 2020.
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