Teacher
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SANTI Luca
(syllabus)
The course is mainly divided into three sections: an initial more general section, a specific section focused on the use of plants for the production of recombinant proteins and a third section where students present in the classroom, in Italian, a scientific paper written in English. Moreover during the course three seminars, taught by guest experts, are planned on specific topics. In the initial section general aims of pharmaceutical biotechnology and pharmaceuticals obtained through biotechnological production are introduced, in this regard some definitions of Biopharmaceutical are provided together with specific examples and the general picture of their worldwide market. In addition, biotech drugs are compared to traditional drugs with particular reference to new approaches for their realization. In this context also recapitulative concepts on recombinant DNA technology strictly applied to pharmaceuticals are provided. All main biological systems for production are analysed: bacteria especially E. coli, yeasts, insect cells, different types of mammalian cells and chicken eggs. Production issues for large scale issues at both upstream and downstream processing level are also addressed in the light of international quality standards and of "Good Manufacturing Practices" (GMP) procedures. In particular specific lessons are dedicated to biofermentations, product processing, techniques of analysis and purification of biological macromolecules and their formulation for their release on the market. After an introduction to immunity, immunogenicity and the immune system of humans, all the main types of biopharmaceuticals: vaccines, polyclonal antibodies, monoclonal antibodies, immunomodulatory proteins and enzymes, in the context of the pathologies to which these drugs are directed to, are defined and described also using specific case studies. At the conclusion of the general section recent developments of nanotechnology in biomedicine and diagnostics and possible future applications in the biopharmaceutical industry are discussed. The second section, all centered on the use of plants for the expression of recombinant polypeptides with pharmaceutical activity, starts with the in depth discussion of plant viruses from a molecular point of view for the importance they have had and continue to have in the development of expression systems. In particular the various strategies of expression and replication of the best known plant viruses are addressed and the systems that make use of these viruses for the heterologous transient expression in plants analyzed in detail. Subsequently the most used plants in biopharmaceutical development (tobacco, benthamiana, rice, maize, potato and tomato) and the different types of genetic modification applicable to these species are addressed (stable nuclear transformation, plastid transformation and transient transformation). Numerous case studies concerning plants developed biopharmaceuticals will be presented and analyzed in detail to illustrate the different approaches in relation to the type of biopharmaceutical, the pathology and the receiving species (for human or veterinary use). The third section focuses on the acquisition of skills in the analysis of scientific international manuscripts and on the acquisition of skills in the presentation and exposure of technical content. To this end, students choose an article from a list of publications selected by the teacher and prepare a power point presentation of about 20 minutes to explain to their class mates, the general theme, the experimental approach, the results and prospects of the work. All selected publications concern the design, implementation and development of biopharmaceuticals in plants. The three seminars that take place during the course are: i) elements of immunology held by Dr. Selene Baschieri from the ENEA Casaccia research center; ii) principles of vaccinology held by Dr. Chiara Lico from ENEA Casaccia research center.
(reference books)
Biotecnologie farmaceutiche; Crommelin D. J., Sindelar R. D.; Zanichelli; 2000; ISBN: 8808094197.
Elementi di Virologia Vegetale; Giunchedi, Conti, Gallitelli, Martelli; 2007; ISBN: 978-88-299-1838-6.
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