Laurea magistrale in Molecular and medical biotechnology

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).