First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
Course unit
MEP7078597, A.A. 2018/19

Information concerning the students who enrolled in A.Y. 2017/18

Information on the course unit
Degree course Second cycle degree in
ME2193, Degree course structure A.Y. 2015/16, A.Y. 2018/19
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Number of ECTS credits allocated 7.0
Type of assessment Mark
Course unit English denomination BIOLOGICS AND BIOPHARMACEUTICALS
Department of reference Department of Pharmaceutical and Pharmacological Sciences
E-Learning website
Mandatory attendance
Language of instruction English
Single Course unit The Course unit can be attended under the option Single Course unit attendance
Optional Course unit The Course unit can be chosen as Optional Course unit

Teacher in charge BARBARA GATTO CHIM/08

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Educational activities in elective or integrative disciplines CHIM/08 Pharmaceutical Chemistry 7.0

Course unit organization
Period First semester
Year 2nd Year
Teaching method frontal

Type of hours Credits Teaching
Hours of
Individual study
Lecture 7.0 56 119.0 No turn

Start of activities 01/10/2018
End of activities 18/01/2019
Show course schedule 2019/20 Reg.2015 course timetable

Examination board
Board From To Members of the board
1 Commissione a.a. 2018/19 03/12/2018 30/09/2019 GATTO BARBARA (Presidente)
MORO STEFANO (Membro Effettivo)

Prerequisites: The student should possess a sound knowledge of molecular biology, cell biology, immunology and pharmacology useful in understanding the development, use and the critical issues related to the use of recombinant proteins in therapy.

Knowledge of the English language is mandatory since the course will be in English, as well as the study material, which will consist for the most part of articles of up-to-date literature. Seminars relating to the subject will also be carried out by international experts in the field (if possible).
Target skills and knowledge: The course aims to enable students to develop a sound knowledge relative to the production, characterization, manipulation and development of novel drugs and diagnostics produced by the use of established and innovative biotechnological processes (biologics).

At the end of the course the student will know the methods of development of biologics and biosimilars, will know the most important and timely issues related to the development, regulatory approval and use of biologicsl and know in detail the classes of approved biologics.
Examination methods: The examination at the end of the course aims to test the student's ability to understand, discuss and present all aspects related to the discovery and use of a biological. To this end, the exam will be a written test (multiple choice).
Assessment criteria: The examination at the end of the course aims to test the student's ability to understand all aspects related to the discovery and use of a biological.
Course unit contents: Introduction: Market and development of red biotech. General principles of biotech processes applied to the production of proteins for therapeutic use. Molecular Biotechnologies. Biotech-related technologies. Analytical methodologies for protein drugs characterization. Legal requirements and normative for biotechnological inventions.

Regulation of biologics (EMA, FDA). Good Manufacturing Practices (GMP) for biotech drugs.

Biosimilars, biobetters and orphan drugs.

Expression methods and criteria for the expression choice. Production and downstream processing of Biotech Therapeutics. Innovation in production.

Immunogenicity, aggregation and glycosylation.

Principal classes of protein therapeutics: Monoclonal Antibodies. Soluble receptors. Cytokines, Growth factors, Hormones, Enzymes, Vaccines.

Principal classes of nucleic acids-based biotech drugs. Antisense. Aptamers. siRNA.
Planned learning activities and teaching methods: The teaching is based on lectures, literature search experiences and research in the computer lab on how to search the databases available for technical information and patents on biological development. Literature searches will be proposed on drugs in clinical phases.

Besides lecturing, the course will use group works to stimulate soft skills scubas critical thinking, team work and peer evaluation. To that extent, a series of questionnaire will be provided to students to help evaluate:
Group assessment
Self evaluation
Peer evaluation
Additional notes about suggested reading: Review and articles from recent scientific literature will be referred and used for teaching purposes through Moodle.
Textbooks (and optional supplementary readings)
  • Crommelin, Daan J. A.; Sindelar, Robert, Pharmaceutical biotechnologyan introduction for pharmacists and pharmaceutical scientistsedited by Daan J. A. Crommelin and Robert D. Sindelar. 2. ed. London: New York, Routledge, --. Cerca nel catalogo
  • Walsh, Gary, Biopharmaceuticalsbiochemistry and biotechnologyGary Walsh. Chichester: Wiley, --. Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Lecturing
  • Problem based learning
  • Questioning
  • Peer feedback
  • Active quizzes for Concept Verification Tests and class discussions
  • Use of online videos
  • Students peer review

Innovative teaching methods: Software or applications used
  • Moodle (files, quizzes, workshops, ...)
  • Socrative

Sustainable Development Goals (SDGs)
Good Health and Well-Being