Il corso si propone di far acquisire allo studente le nozioni relative all’utilizzo di sistemi ricombinanti per la produzione di biofarmaceutici. In particolare, il percorso formativo si focalizza sulle tecniche bio-molecolari utilizzate per l’espressione di proteine ricombinanti in sistemi procariotici ed eucariotici ed i sistemi per la loro purificazione su scala industriale. I diversi sistemi di produzione saranno studiati singolarmente e confrontati. Si prenderanno in considerazione le diverse procedure utilizzate per l’approvazione di un biofarmaceutico sul mercato con confronti tra la regolamentazione americana ed europea. Esempi specifici di molecole prodotte in sistemi ricombinanti e loro applicazioni in ambito terapeutico (vaccini e anticorpi), saranno illustrati e approfonditi.
OUTLINE OF THE COURSE OF MOLECULAR FARMING
• L1: General introduction to the course and to Molecular Farming
• L2: Biopharmaceuticals and Drugs. The major Regulatory Agencies.
-Com: Redefining Biopharmaceuticals
• L3: Clinical Trials design
-C: P value
• L4: Biosimilars and Bioequivalence
-R: Key considerations in the preclinical development of biosimilars
• L5-6: Platform for the expression of recombinant protein: Bacterial and
Yeast Cell cultures
-M: Gateway Cloning Technology
-C: Molecular Cloning – Selected Applications in Medicine and Biology
-A: Expression of recombinant proteins in the methlotrophic Yeast Pichia pastoris
• L7: Platform for the expression of recombinant protein: Baculovirus and Insect Cell cultures
-Man: Baculovirus, insect cell expression
• L8-9: Platform for the expression of recombinant protein: Mammalian Cell cultures
-R: Bioreactors and cultivation systems for cell and tissue culture
-C: Cell Culture Bioreactors
-M: overview of transfection Methods
• L10: Platform for the expression of recombinant protein: Transgenic
Animals
• L11: Platform for the expression of recombinant protein: Plant Systems
-R: Plant Molecular Farming: much more than medicine
• L12: Platform for the expression of recombinant protein: Plant Systems, Stable transformation
-R: The increasing Value of plant-made proteins
• L13: Platform for the expression of recombinant protein: Plant Systems, Transient transformation
-R: Viral vectors for the expression of protein in plants
• L14: The antibodies from passive immunization to immunotherapy
-R: Therapeutic antibodies for autoimmunity and inflammation
• L15: Heterologous expression of antibodies
-B: Antibody expression and purification
• L16: Production of antibodies in recombinant systems
-A: Universal protection against influenza infection by a multidomain antibody to influenza hemagglutinin
• L17: Post-translational modifications and immunogenicity of biotherapeutics
-R: Bioequivalence and immunogenicity of biopharmaceuticals
• L18: Active immunization: the vaccines
-C: Vaccine Immunology
• L19: Vaccine Manufacturing
-C: Vaccine manufacturing
• L20: Immunological tolerance
• L21: Recombinant production of peptides
-T: Plant viruses for peptide expression in plants
• L22: Techno-economic analysis for the production of antibodies
-A: Techno economic analysis of a transient plant based platform for
monoclonal antibody production
• L23: Downstream processing of biopharmaceuticals
-G: Process Validation: General Principles and Practices
• L24: Production and clinical trials for a specific biopharmaceutical:
references
L’esame finale consiste in una prova orale che verterà sugli argomenti trattati durante il corso (punteggio massimo 27) e su una tesina che descriverà uno specifico biofarmaceutico, le sue applicazioni e il sistema o sistemi di produzione (punteggio massimo 3).
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