Bit.Bio iPS-derived hepatocytes

Waiver Rationale Summary

IPSCs hold promise to enable the generation of many different cell types from any human donor for a wide array of cell diversity and application in biomedical research. IPSCs have tremendous potential in disease modeling, toxicological assessments, drug discovery, and regenerative therapies. These cells are an attractive research model because they can allow the researcher to conduct experiments that mimic the genetic diversity of human populations. iPSCs can be differentiated into all the cell types in the human body. However, the differentiation process is time-consuming and costly. Moreover, the different protocols used for differentiation can lead to varying results, including different levels of heterogeneity in the final cell population. In toxicological research, it is important to identify the target cell of a given chemical, the chemical-induced changes specific to that cell type, and the effects these cells can have on other cell types in the tissue/organ. Therefore, having a pure, or highly purified population of differentiated cells derived from iPSCs can be provided by Bit.Bio would be highly beneficial to our research. These cells would provide a high level of confidence that the data generated would be reliable and reproducible. Bit.Bio can provide all of the cell types required for our research program. Months of scientific literature research, as well as mining of the Internet resources aimed at finding domestic providers of the appropriate cell types, did not produce adequate results that could meet our research needs. Our consultations with 3 vendors directly for methods of generating cells, of cell quality and specific city, and of types of cells available did not meet our expectations on the quality, purity or types of cells that could be provided by these vendors to meet the needs of our research. Bit.Bio was unique in that they could not only meet all our needs in the quality and purity of their differentiated cell types but also could provide all of the cell types needed for our research. Moreover, since many US and overseas laboratories already utilize these cells, its inaccessibility to our research team puts the NIEHS at a significant disadvantage in international and national competitive studies. In conclusion, we believe that granting the required waiver to procure these required cells, which is not available domestically in the US, will allow the program office to successfully fulfill the DTT and NIEHS mission.