BIOLOGICS AND BIOPHARMACEUTICS

Second cycle degree in PHARMACEUTICAL BIOTECHNOLOGIES

Campus: PADOVA

Language: English

Teaching period: First Semester

Lecturer: BARBARA GATTO

Number of ECTS credits allocated: 7


Syllabus
Prerequisites: The student should possess a sound knowledge of molecular biology, cell biology, immunology and pharmacology useful in understanding the development, use and the critical issues related to the use of recombinant proteins in therapy.

Knowledge of the English language is mandatory since the course will be in English, as well as the study material, which will consist for the most part of articles of up-to-date literature. Seminars relating to the subject will also be carried out by international experts in the field (in English).
Examination methods: The examination at the end of the course aims to test the student's ability to understand, discuss and present all aspects related to the discovery and use of a biological. To this end, the exam will be a written test (multiple choice).
Course unit contents: Introduction: Market and development of red biotech. General principles of biotech processes applied to the production of proteins for therapeutic use. Molecular Biotechnologies. Biotech-related technologies. Analytical methodologies for protein drugs characterization. Legal requirements and normative for biotechnological inventions.

Regulation of biologics (EMA, FDA). Good Manufacturing Practices (GMP) for biotech drugs.

Biosimilars, biobetters and orphan drugs.

Expression methods and criteria for the expression choice. Production and downstream processing of Biotech Therapeutics. Innovation in production.

Immunogenicity, aggregation and glycosylation.

Principal classes of protein therapeutics: Monoclonal Antibodies. Soluble receptors. Cytokines, Growth factors, Hormones, Enzymes, Vaccines.

Principal classes of nucleic acids-based biotech drugs. Antisense. Aptamers. siRNA.