Cell Processing Information
Customers purchasing cell lines from EBiSC will benefit from:
- Our robust and standardised approach to stem cell banking.
- Adherence to international best practice standards covering all stages from consent and procurement to distribution.
- Our dedicated support to research through provision of a high quality, well characterised, collection of hiPSC lines from a range of genetic backgrounds and reprogramming methods.
- Quality certification for all batches from our standardised process of expansion, cryopreservation and Quality Control at our dedicated central facilities.
EBiSC ensures the quality of all cell line banks using the following processes:
Standardised Cell Culture Conditions:
- All cell lines distributed by EBiSC have been banked and rigorously tested under a bespoke quality manual
- All lines are adapted to standardised, antibiotic-free culture protocols to maximise efficiency of use.
- Reproducibility and homogeneity of cell material is assured.
- This ensures consistency across experiments involving multiple cell lines.
- This eases data comparison with data sets produced across multiple sites using the same source material.
Core Quality Control Regime:
All QC tests have under gone qualification and are performed and documented to industry standards agreed by EFPIA. Core QC includes:
- Cell line identity: use of STR profiling allows for affordable ID comparisons during use
- Phenotype: expression of gold-standard hPSC and self-renewal markers
- Viability: confirmation gives confidence to users of ease of use of each cell line
- Karyology: Genome health of each cell line recorded with data on chromosomal complement made available to users
- Microbiology: Every batch is screened for bacteria, fungi, Mycoplasma and selected human viral pathogens (HIV1, HIV2, HBV and HCV; N.B. viral screening may have been performed on donors or donor tissue)
- Additional characterisation data may include:
- Pluripotent potential through spontaneous or directed differentiation
- Directed differentiation to somatic cell types
- SNP array data
- Characterisation of genetic lesion
- Sequencing data
Batch specific Quality Control data is provided on a Certificate of Analysis supplied at cell line receipt, additional data sets are available at ebisc.org.
All testing methods used by EBiSC have a finite sensitivity and lifespan. Therefore, recovered cultures should be treated as if potentially infectious and screened for pluripotency, cell line identity and chromosomal stability on a regular basis. Advice on appropriate methodologies can be obtained from EBiSC. EBiSC considers all iPSC lines as genetically modified as even non integrating systems may retain undetectable levels of reprogramming factors. All users should evaluate the cells with their local safety offices prior to use. It is possible that some lines may retain expression of reprogramming factors, and where this has been detected by EBiSC it will be made clear to you at the point of purchase. Guidance on methods for removal of reprogramming factors can be found in the EBiSC Cell line User Protocol.