Chemistry, manufacturing, and control (CMC) assessment of Manganescan
To design effective and patient-specific cancer therapy, sensitive detection of relapse and distant metastases by non-invasive medical imaging is essential, for which MRI offers tremendous potential due to wide availability of the equipment in clinic and avoidance of ionizing radiation. Although gadolinium-based contrast agents are the most frequently used for MRI, they are associated with nephrogenic systemic fibrosis and brain deposition. Thus, less toxic manganese ions are exploited as an alternative for tumor detection using MRI. Yet, the current formulations of manganese ions cannot provide desirable results due to low tumor uptake after systemic administration. To address the need, Nanology Labs offers a novel manganese-based MRI contrast agent, called Manganescan, which is able to detect solid tumors and brain metastasis at early stages. In this project we aim at evaluating physiochemical properties of the agent under regulatory quality control guidance.