Custom Banking

The complete iPSC workflow – Custom iPSC generation, validation, and storage

Work with Catalent’s iPSC expert team to reprogram, expand and characterize your custom iPSC bank within our fully optimized GMP-compliant workflow.

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Reprogramming	Proprietary reprogramming protocols built on longstanding experience in iPSC generation. We ensure consistent outcomes and confirm vector elimination via whole genome sequencing
Characterization, manipulation and release testing	Depending on your needs, we offer a full validation package or individual assays in our three Grade A-in-B cleanrooms. Certified HLA typing and matching to our clinical-grade HLAh iPSC library Certified karyotyping and STR genotyping Next-generation genomic DNA (gDNA) sequencing Quantitative gene expression analysis Immunocytochemical characterization (flow cytometry and Immunofluorescence (IF) Pluripotency assessment via three-germ layer differentiation Custom qPCR analyses Certified sterility, endotoxin, virus & mycoplasma testing
Differentiation	We develop GMP-compliant differentiation protocols and workflows, with full characterization of the differentiated cells. Our process development and manufacturing teams will also work with you to manufacture, at scale, GMP-compliant iPSC banks and differentiated cells
Cryopreservation & banking of iPSCs	Store your iPSCs or differentiated cells in our state-of-the-art cryo storage facility. Climate-controlled and monitored for unauthorized access, our storage space features vapor-phase liquid nitrogen tanks that are temperature-monitored and connected to a robust emergency system.