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Development of novel radiolabelling method for low dose drug products for investigation of in Vivo performance in gamma scintigraphic studies.

There is an unmet need in the industry for a more efficient and flexible approach to provide drug product for early clinical studies. Presented here is an innovate approach to overcome these challenges by utilising a real-time, adaptive manufacturing and supply platform.

The key objectives of human ADME studies are to evaluate mass balance, determine the routes and rates of elimination and gain an understanding of the metabolic fate of the drug.

Conduct of clinical ADME study for Vosaroxin in oncology patients via real-time adaptive manufacture of intravenous drug product.

This poster reports on a new real-time adaptive GMP manufacturing paradigm serving patient and study needs by delivering personalized drug products on demand.