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Cited by 50

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

O'Shea, Orla, Steeg, Rachel, Chapman, Charlotte, Mackintosh, Peter, Stacey, Glyn N·2020·Stem Cell Research
DOI 10.1016/j.scr.2020.101773
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Abstract

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.

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Crossref · 10.1016/j.scr.2020.101773

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  • Genetic variants may exhibit a number of changes including point mutations, small deletions, rearrangements, inversions, gene amplifications, and chromosome loss or aneuploidy, but it is typically difficult to predict their impact on functionality or patient safety in clinical applications.

    “Genetic variants may exhibit a number of changes including point mutations, small deletions, rearrangements, inversions, gene amplifications, and chromosome loss or aneuploidy, but it is typically difficult to predict their impact on functionality or patient safety in clinical applications (O'Shea et al., 2020).”

    From Guidance document on Good cell and tissue culture practice 2.0 (GCCP 2.0) (2021) · cites this paper as O'Shea et al., 2020

  • Visual assessment is not sufficient, and daily medium change with defined serum-free medium can repress contaminations to levels only detectable using a TSB/FTB broth inoculation.

    “Note that visual assessment is not sufficient, and daily medium change with defined serum-free medium can repress contaminations to levels only detectable using a TSB/FTB broth inoculation (O'Shea et al., 2020).”

    From Guidance document on Good cell and tissue culture practice 2.0 (GCCP 2.0) (2021) · cites this paper as O'Shea et al., 2020

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Authors
O'Shea, O., Steeg, R., Chapman, C., Mackintosh, P., & Stacey, G. N.
ORCID
Venue
Stem Cell Research
Publisher
Elsevier BV
Published
2020-05
Volume
45
Pages
101773
ISSN
1873-5061
DOI
10.1016/j.scr.2020.101773
Cited by
50
References
0
Language
en
Licence
Funders
  • Innovative Medicines Initiative
  • Horizon 2020

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