Quality Control
Where possible Roslin Cells performs all testing in-house, otherwise contract labs have been identified which can provide the appropriate testing at the required standard. Services provided by these contract labs are defined under Service Level Agreements (SLAs), and are sourced locally, where possible.
Roslin Cells assays are qualified to ensure their suitability for use. Assays are performed by trained staff, following written procedures and using appropriate internal controls. Assay acceptance criteria are developed and continually trended and monitored. All equipment used is fully validated following an impact assessment to determine its criticality. It is intended that assays will be qualified to ICH standards once the cell lines produced are to be used in a clinical therapy.
Roslin Cells ensures that it is well placed to adapt to the rapid pace of new developments in hESC culture and associated analytical techniques. . It is a real possibility that currently accepted standard assays may be replaced by more superior techniques in the near future and it is the aim of Roslin Cells to keep up to date with these new developments.
All cell lines derived by Roslin Cells are subject to the following testing:
| Classification | Test | Purpose |
|---|---|---|
| Identity | Microsatellite PCR (mPCR) | DNA Profiling to give cell line its signature, gender/species |
| Phenotype | Immunocytochemisty | To establish levels of staining for Oct 4 and Nanog |
| Alkaline Phosphatase (AP) Staining | Visual assessment of levels of undifferentiated cells within the line | |
| Flow Cytometry | Assess antigen levels & cell surface markers commonly associated with hESC e.g. SSEA-1, SSEA-4, Tra-1-60, Oct 3-4 | |
| Gene Expression Array | Array to investigate whole genome gene-level expression of pluripotent cells from RNA extracts using Taqman Low Density Arrays (TLDA). | |
| Genotype | Blood Group Genotyping (DNA Analysis) |
To establish full blood group genotype of the line |
| Karyology (G-Banding) | Analysis of aberrations by G-banding. | |
| Microbiology and Virology | Mycoplasma Ph. Eur. / Ph. US |
Full Mycoplasma testing to EP/USP guidelines. |
| Viral Screening by qPCR | Screening for HIV 1 + 2, HBV, HCV, EBV, hCMV, HTLV 1/2 | |
| Endotoxin | Screening for Endotoxin contamination | |
| Sterility Ph. Eur. / Ph. US |
Full sterility testing to EP/USP guidelines. | |
| Pluripotency | Teratoma | Establish the potential of stem cell line to give rise to cells from each of the embryonic germ layers in SCID mice |
| Embryoid Bodies | To establish the capability of the line to form the 3 germ layers in vitro | |
| Viability | Live/Dead Stain | To determine the viability of the line |
| Morphology | Photography | To capture a visual image of the line. |
