The Approach
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. From there the cells can be expanded into cell banks and/or differentiated into the cells of choice.
The Challenge
The reprogramming and validation of iPSCs remains a big challenge in iPSC therapeutic development. Other challenges include removal of epigenetic changes programmed into the somatic cells, cell stability over long term culture, differentiation down specific lineages to make cells of interest, and the effective removal of the iPSC from the therapeutic product to remove the risk of teratoma formation or other deleterious effects.
At Theragent, we understand that production of iPSCs must be streamlined and simplified 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, they continue to show tremendous therapeutic promise and are certain to be a standard in the future of cell therapy. The draw of a limitless cell source for allogeneic therapeutics that has the potential for unlimited differentiation is undeniable and therefore, most people expect iPSCs to be the predominant starting material for cell therapies in the future.
At Theragent, we understand that production of iPSCs must be streamlined and simplified to be GMP compliant. Furthermore, the successful generation of iPSC therapies must include GMP/GCP compliant tissue acquisition, effective cell isolation and large-scale expansion, highly efficient reprogramming, vast cell banking formulated for long-term stability, and very in-depth characterization. Connect with our experts to see how we are uniquely equipped to accelerate your clinical iPSC program.