Custom-Made Designer Macrophages to Revolutionize the Safety of Parenteral Drugs

The iPYRO proposal is built upon the uniqueness of human induced pluripotent stem cells (iPSC) and recent innovations in the farming of fully defined human macrophages (iMonoMac) using industry compatible bioreactors. Given the growing need for industrial macrophages, iPYRO sets an innovation in the forefront of drug safety evaluations, supplying a unique cell type, which meets the expectations from industry and regulators. The breakthrough innovation of iPYRO will offer a superior, thus highly standardized, economically produced and fully validated off-the-shelf macrophage-based cell product to revolutionize the safety of drugs and beyond. To maximize the outcome, iPYRO will assess the regulatory compliance, while further streamlining the iMonoMac product for the envisioned spinout, establishing a proper freedom-to-operate strategy and a suitable business model. The seminal iMonoMac platform along the unique IPR and established contacts to industrial and regulatory stakeholders will pave the transition from academia to industry, introducing for the very first time an iPSC-cell product for the drug safety market market.