Most Cell lines Used in Testing May Be Incorrectly Identified
[Posted on: Thursday, October 15, 2015]

Recently several reports have raised the question of authenticity of the cell lines used in research and development activities. Most testing labs and academic centers do not validate cell lines before use. Rather it follows the honor code of trusting the label given by the provider. But cell-line misidentification has been a major concern for a few years. Over the last 50 plus years, cell lines have been extensively shared among researchers, cloned, banked, and distributed. In the process, it is suspected that many common cell lines got contaminated with other cell types, exchanged genetic elements, or simply transformed. This lead to a concern that without proper validation of the cell type, any experiments conducted with a given cell line may be highly suspicious at best. It is estimated that more than 438 cell lines used in research are no longer what they claim to be. In most cases, the origin of the contaminating cell types is not known. So far, FDA and other regulators have not raised any questions about cell culture studies, at least not in public, but any cell culture based proof of concept can certainly be questioned. The impact of this observation may be limited as drug research still relies heavily on animal and clinical testing. But this report does pour cold water on plans for more aggressive cell culture testing to build hypothesis for mode of action and efficacy of many drugs. For example, many cancer drug screening depends on cell culture based testing, which could be questioned without cell line validation data. At present the drug developers can put this issue on the back burner to be addressed later.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research