Cell Line Testing
Roslin Cells extensive characterisation and adventitious agent testing provides a clear picture of each cell lines' identity, sterility, purity, quality and potency. Together these tests give confidence that our stem cell lines are safe to take forward for therapeutic applications.
Cell Line Characterisation
At Roslin Cells each line is characterised at the earliest stage possible, then again following stability studies, and finally at the point of laying down a seed lot. The testing performed allows for a clear picture of the identity, viability, stability and functionality of each line.
Roslin Cells perform a standard package of characterisation tests on each line:
- Genetic Identity by Short Tandem Repeats (STR)
- Flow Cytometry
- Immunocytochemistry
- Karyology by Geisma-Banding
- Teratoma Studies
- in vitro Differentiation
- Protocols for the Formation of Embryoid Bodies
In addition Roslin Cells uses the latest technology to provide more specific information on each line:
- Comparative Genome Hybridisation (CGH)
- Gene Expression Profiling (Phenotype and Pluripotency Assays)
Adventitious Agent Screening
Screening for adventitious agents starts with collating information on the tissue donors. This work is performed by research nurses at the donation centres and the information is anonymised and reviewed by Roslin Cells.
All donated tissue is initially quarantined upon arrival until sufficient testing is performed. Testing for bacteria, yeast, fungi, endotoxin and mycoplasma is performed according to a pre-defined schedule during ongoing culture, and on establishing seed lots.
As part of quarantine release testing, and again before seed lot banking all lines are subject to further sterility testing and in addition screening for the absence of viral contaminants. This is done for a panel of the most common viruses using fully qualified quantitative real-time PCR assays.
