Formulation and Legislation of Monoclonal Antibodies, Nanovectors, and Advanced Therapy Medicinal Products

The purpose of this course is that students gain knowledge on the critical aspects related to
- biopharmaceutics of parenteral dosage forms;
- formulation of monoclonal antibodies and drugs loaded nanovectors, with particular emphasis to lipid based nanosystems;
- regulation of manufacturing and processes to grant the marketing authorization of medicinal products.

At the end of the course, students are expected to know:
- the basic information on dispersed systems and their physical stabilization;
- the key critical attributes of parenteral dosage forms: sterility, isotonicity, isohydria and endotoxins;
- main methods of preparation and drug loading of nanovectors;
- absorption and distribution of monoclonal antibodies and drug loaded nanovectors administered by the different parenteral routes of administration;
- to outline the steps required to place a medicinal product on the market, with a focus on complex drugs and advanced therapy medicinal products. They are expected to be able to retrieve and understand the relevant parts of EU legislative acts.