Content (Syllabus outline)
- Introduction to the biotechnology of drug substances
- Molecular biotechnology
- Expression systems, manufacture of biologicals
- Isolation and identification of biologicals
- Impurities and formulations of biologicals
- Peptide drugs
- Biotransformation of drug substances
- Biosimilars
- Regulation in the field of biologicals
- Therapeutic groups
- Insulins and other recombinant hormones
- Interferons, interleukins and other cytokines
- Erythropoietins
- Coagulation factors, thrombolytics
- Vaccines
- Immune system and manufacture of monoclonal antibodies
- Groups of monoclonal antibodies according to their indications
- Novel R&D of therapeutic antibodies
- Nucleic acid as drug substances
- Basics of gene and advanced therapy with cases
Prerequisites
Terms of Prerequisites:
- 100% presence at practical courses
- seminar: presentation of a scientific article