The aim of the course is to provide general knowledge on the role of the formulation in the storage, stability, release and bioavailability of biological and biotechnological drugs. At the end of the course the student will acquire theoretical and methodological knowledge related to the formulation of biotech drugs.
Course Prerequisites
The course requires basic knowledge in chemistry and biochemistry.
Teaching Methods
Theoretical lessons (blended). There are no practical exercises. For students with specific needs who are unable to attend educational activities in person and have applied for Inclusive Learning Modes, suitable educational materials will be made available for effective independent study. If requested, self-learning can be supported by tutoring or supplementary teaching activities, as well as dedicated meetings, including online, with flexible scheduling according to individual needs.
Assessment Methods
In itinere tests - none
Learning check - Oral presentation on a topic of your choice (attending students) OR written exam based on multiple choice questions.
Tailored examination procedures are implemented for students classified under Specific Learning Disorders (SLD) and Special Educational Needs (SEN), in accordance with applicable regulations and institutional guidelines
Texts
Slides and other educational material useful for the exam preparation will be published on Kiro platform.
Contents
Biopharmaceutical and pharmacokinetic aspects related to administration of peptide/protein drugs. From biotech drug to “drug delivery system”: preformulation studies, formulation and stability issues for dosage forms containing biotech drugs (insulin, growth hormone, eritropoietin, interferons, plasminogen tissue activator, vaccines). Freeze-drying and spray-drying processes. PEGylation of peptides and proteins. Formulation and administration of DNA, RNA and oligonucleotides. Biosimilar medicines. Regulatory approaches and criteria for biotech medicines approval.
Course Language
Italian
More information
All the educational material is provided by Kiro platform.
