Master's degree in Molecular and Medical Biotechnology

Farming molecolare

Course code
4S003677
Name of lecturer
Linda Avesani
Coordinator
Linda Avesani
Number of ECTS credits allocated
6
Academic sector
BIO/15 - PHARMACEUTICAL BIOLOGY
Language of instruction
English
Period
I semestre dal Oct 1, 2019 al Jan 31, 2020.

Lesson timetable

Go to lesson schedule

Learning outcomes

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. Specific examples of biopharmaceutical produced in recombinant systems and their therapeutic applications like for vaccines and antibodies will be discussed and studied.

Syllabus

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

Assessment methods and criteria

The final exam consists in an oral test on the topics of the course (max 27 points) and on a written report on a specific biopharmaceuticals, covering both its production platform/s and its therapeutic use (max 3 points).





© 2002 - 2019  Verona University
Via dell'Artigliere 8, 37129 Verona  |  P. I.V.A. 01541040232  |  C. FISCALE 93009870234