4.2 Article

Development and implementation of large-scale quality control for the European bank for induced Pluripotent Stem Cells

Journal

STEM CELL RESEARCH
Volume 45, Issue -, Pages -

Publisher

ELSEVIER
DOI: 10.1016/j.scr.2020.101773

Keywords

EBiSC; iPSC; Quality control; Quality; Characterisation; European; Repository

Funding

  1. Innovative Medicines Initiative Joint Undertaking from the European Union's Horizon 2020 research and innovation programme [115582]
  2. Innovative Medicines Initiative 2 Joint Undertaking (JU) from the European Union's Horizon 2020 research and innovation programme [821362]
  3. EFPIA

Ask authors/readers for more resources

The European Bank for induced Pluripotent Stem Cells (EBiSC) has collected iPSC lines associated with genetic diseases and healthy controls from across Europe and made these available for research use to international academic and commercial users. Ensuring availability of consistently high quality iPSCs at scale and from various sources requires quality systems which are flexible yet robust, maximising the utilisation of available resources. Here, we outline the establishment and implementation of a quality control regime suitable for a large-scale operational setting. Strict release testing ensures the safety and integrity of distributed iPSC lines, whilst informational testing allows publication of full characterisation and assessment of iPSC lines. Quality control screening is underpinned by a 'fit-for-purpose' Quality Management System giving full traceability and supporting continuous scientific and process development. Evaluation and qualification of key assays and techniques ensures that assay sensitivities and limits of detection are acceptable. Use of rapid testing techniques in place of more ?traditional ? assays allows EBiSC to respond quickly to user demand, generating fully qualified iPSC line banks in a labour-saving and cost-efficient manner.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.2
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

No Data Available
No Data Available