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EBISC iPSCs: establishment and implementation of a quality control regime

 

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ECACC is an official global distributor of iPSC lines from the European Bank of induced pluripotent Stem Cells (EBiSC), whose purpose is to make human induced pluripotent stem cells (iPSCs) easily accessible to the international scientific community. EBiSC is a central repository of iPSC lines of different provenances and provides the supply of quality-controlled iPSC lines for research use.

One of the greatest challenges the EBiSC consortium has come across was to build a robust and standardised Quality Control (QC) system capable of providing the availability of high quality iPSCs at scale and from various resources. EBiSC lines are collected from diverse study centres with differing approaches in cell line generation, QC and characterisation, and so the development of the QC process has been extremely critical. In the recent publication of 'O’Shea et al' report, EBISC developed the essential requirements for establishing a QC system able to rapidly and efficiently test a broad number of iPSC lines1.

All iPSC line batches released by EBISC are tested to assure viability, identity and sterility, identified as common failures and critical issues across the scientific community. Moreover, additional cell line characterisation such as flow cytometry for marker expression, assessment of IPSCs morphology, genomic stability and pluripotency potential is performed to guarantee the suitability of lines for downstream uses. Embryoid bodies and direct differentiation assays were developed to estimate the functional pluripotency analysing the expression of specific markers associated to the three germ layers. Flow cytometry was used to assess the proportion of each iPSC line which expressed markers associated with pluripotency and self-renewal. Furthermore, the evaluation of the genomic stability was also included in the characterisation as human PSCs are known to be susceptible to genetic drift over lengthy time in culture and it was obtained by G-Banding and/or SNP analysis. All assays went through robust qualification, including, where appropriate, the verification of sensitivity limits, robust and suitable positive and negative controls and qualification with numerous test samples.

ECACC follows EBISC guidance on how routine iPSC line QC needs to be performed for ensure high-quality iPSCs and their suitability for streamline applications as models for the study of diseases and screening of therapeutic drugs.

 

Further Information: 

1. O'Shea, O., et al., Development and implementation of large-scale quality control for the European bank for induced Pluripotent Stem Cells. Stem Cell Res, 2020. 45: p. 101773.

ECACC is an official global distributor of iPSC lines from the European Bank of induced pluripotent Stem Cells (EBiSC)

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Written by Rosa Loffredo

July 2020

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