Quality Assurance

Germ Layer Differentiation

iPS cell clones undergo directed differentiation for 5-10 days depending on the germ layer and are formalin fixed. Germ layer antibody expression identified by immunohistochemistry with DAPI nuclear counterstain.

Ectoderm

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Nestin (red) and Pax-6 (green)

Endoderm

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FoxA2 (red) and SOX17 (green)

 

Mesoderm

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NCAM (red) and Brachyury (green)

Evaluation of Pluripotency Marker Expression and iPS Cell Novelty

Clone-specific iPS colony cells with a passage less than or equal to 10 are stained for the pluripotency markers Oct4, SSEA, Nanog and TRA-1-60 with DAPI nuclear counterstain. iPS cells also undergo flow cytometry to quantify and demonstrate pluripotency.  

Flow Cytometry

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Pluripotency Markers Oct4 and SSEA

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Oct4 (red) and SSEA (green)

 

Pluripotency Markers Nanog and TRA-1-60

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Nanog (red) and TRA-I-60 (green)

 Certificate of Analysis

After each iPS clone line undergoes and successfully passes our quality control measures, results are compiled in to a comprehensive report. This certificate of analysis includes staining images from germ layer differentiation and pluripotency marker expression, as well as flow cytometry scatter plots and quantified protein results. Karyotyping is also performed on each clone, and a full cytogenetic report is provided. The Certificate of Analysis report is included with each requested iPS clone line.  

Example of Biotrust CoA

 

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