iPSCs are derived from somatic cells, making them a sustainable and ethical solution in response to concerns raised regarding ESC-based therapies. The somatic cells are re-engineered via transcription factors that upregulate genes related to pluripotency. Pluripotency is validated by confirming the presence of cell surface markers and genes specific to pluripotent cells.
The reprogramming and validation of iPSCs remains the biggest challenge in iPSC therapeutic development.
At Theragent, we understand that production of iPSCs must eliminate xenogeneic agents and feeder cells to be GMP compliant.
Several US companies have iPSCs in early-stage clinical trials. Study participants have not reported any adverse events to date, which has furthered the investments in iPSC pipelines. While no iPSC clinical trials have moved to late stages due to the rigorous cell culture and validation requirements of iPSCs, they continue to show tremendous therapeutic promise.
At Theragent, we understand that production of iPSCs must eliminate xenogeneic agents and feeder cells to be GMP compliant. Additionally, GMP-compliant scale-up of iPSC therapies must include compliant tissue acquisition, cell isolation and expansion, reprogramming, cell banking, and characterization. Connect with our experts to see how we are uniquely equipped to acclerate your clinical iPSC program.