Production, Legislation and Marketing of Biotechnological Medicines

The course is intended to cover principles and general requirements for the development of biotechnological medicinal products, from biopharmaceutics to the manufacturing of the final dosage form. References are made to the quality assays, compendial and not, to characterize the finished medicinal products Regulatory aspects relevant to production and marketing are also addressed.

At the end of the course, students are expected to know the relation among the specific properties of an active substance, dosage form, administration site and the therapeutic requirements in order to formulate a medicinal product complying the requirements of quality, safety and efficacy. Starting from the main chemical-physical characteristics of the active substance, the student will be able to propose the most suitable route of administration, manufacturing methods for biotechnological and advanced therapy medicinal products to according to the Good Manufacturing Practices.