Custom iPSC Banking and QC
Using our approved reprogramming process as a platform, we also offer custom reprogramming and iPSC banking as a service – using either internal or external cell lines. The services apply our proven animal-free culture conditions and a comprehensive portfolio of validated QC assays, as well as optional QP release by Catalent. Certainly, if desired, the set of QC assays can be extended according to our partners’ specific needs.
Validated QC assays
| • Sterility | • Cell identity |
| • Endotoxin | • Cytogenetic analysis |
| • Mycoplasma | • Mutational burden |
| • Viral safety | • Flow cytometry |
| • Vector elimination | • Immunofluorescence |
| • Cell recovery from MCB | • RT-qPCR analysis |
| • Morphology | • 3-germ layer differentiation |
For example, we have established algorithms for mutation scoring based on whole-genome sequencing as a release assay. Hence, beyond standard oncogene panels that we screen against, we can extend the set to cell type-specific genes of interest. If QP release by Catalent is not required, we are also flexible in production. Overall, our expert R&D and PD teams are experienced with various culture and iPSC manipulation techniques such that alternatives may rapidly be translated to a clean room setting.
