Purification and Formulation of Biotechnological Drug Products

· The process of isolation and purification of biotechnological drugs: glossary and regulatory framework
· Types of bioproducts and their most common contaminants
· Rational approach to process development I: old and new experimental approaches
· Rational approach to process development II: old and new technologies
· Rational approach to process development III: quality and quality by design
· Basic principles of biotech industrial filtration
· Bacterial and viral contamination and viral clearance
· Verification of the concepts learned: detailed drawing of a new process
· Notions of business administration in the biotech production field

Pharmaceutical Legislation
· Definition of medicinal product
· Manufacturing authorization for human medicinal products and marketing authorization procedures. Introduction to the centralised procedure, conditional marketing authorization and marketing authorisation under exceptional circumstances
· Requested data from EMA for biotechnological medicinal products.
· European Medicines Agency (EMA) and Agenzia Italiana del Farmaco (AIFA).
· Generic medicines and biosimilars.
Pharmaceutical Technology
· In-depth analysis of pharmacokinetics and biopharmaceutical aspects of the routes of administration.
· Modified drug delivery systems: rational and formulative approaches.
· Parenteral dosage forms: rational and formulative approaches.
· Inhalation and nasal drug delivery systems.
· Non-conventional drug delivery systems: nanoparticles and liposomes.
· Scaffolds for tissue engineering
· Water for pharmaceutical use.
· Containers and closures
· Sterilization process and EMA decisional tree.