The course aims to give the students notions of the use of recombinant systems for the production of biopharmaceuticals. In particular, the course will be focused on the biomolecular techniques used for the expression of recombinant proteins in prokaryotic and eukaryotic systems and the downstream processing and purification for their large-scale production. The different platforms used for the recombinant expression will be studied and compared. The different US and EU normative procedures for biopharmaceutical commercialization will be evaluated and compared, starting from pre-clinical studies. Specific examples of biopharmaceutical produced in recombinant systems and their therapeutic applications like for vaccines and antibodies will be discussed and studied.
1) Definition of a biopharmaceutical, comparison with synthetic drugs and botanical drugs.
2) Clinical development of a biopharmaceutical and IP role.
3) Platforms used for the production of a biopharmaceutical (cellular lines and whole organisms). Methods for the production of recombinant proteins using: bacterial cells, yeasts, plant cellular lines, insect and mammalian cells, transgenic plants and animals.
4) Classes of biopharmaceuticals: vaccines, hormones and antibodies; therapeutic applications and production systems.
5) Techno-economical analysis of the production of a biopharmaceutical
The final exam consists in an oral test on the topics of the course and on a written report on a specific biopharmaceuticals, covering both its production platform/s and its therapeutic use.
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