First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
Course unit
MEP7078597, A.A. 2019/20

Information concerning the students who enrolled in A.Y. 2018/19

Information on the course unit
Degree course Second cycle degree in
ME2193, Degree course structure A.Y. 2015/16, A.Y. 2019/20
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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 30/09/2019
End of activities 18/01/2020
Show course schedule 2019/20 Reg.2015 course timetable

Examination board
Board From To Members of the board
2 Commissione a.a. 2019/20 02/12/2019 30/09/2020 GATTO BARBARA (Presidente)
MORO STEFANO (Membro Effettivo)

Prerequisites: The student should possess a sound knowledge of biochemistry, molecular biology, cell biology, immunology and pharmacology useful in understanding the design, production, use and regulatory issues related to the use of recombinant proteins in therapy.
Target skills and knowledge: The course aims to prepare students on the methods of production, characterization, manipulation and development of new drugs produced through biotechnological ("biological") processes, acquiring knowledge on:
- their identity, chemistry, and importance in the pharmaceutical context
- how they are produced
- how they are regulated
- how they are used.

At the end of the course the student will know
- the meaning and methods of upstream and downstream processing,
the most important and current problems related to the development, regulation, approval and use of biological and biosimilars,
- the classes of approved biologicals.

He will also be able to
- use the tools provided by EMA concerning the search, approval, identity and use of the biologicals in clinical use approved in Europe
- understand and discuss current issues related to the use of biosimilars.
Examination methods: The examination at the end of the course aims to test the student's ability knowledge and understanding of 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 knowledge and understanding of all aspects related to the discovery and use of a biological.
In the multiple choice text, the student will be evaluated according to the percentage of correct answers. No penalties will be applied for wrong answers.
Course unit contents: Introduction: meaning and implications of the term "biological".
Differences between biologicals and small molecules
Market and development of biological drugs.
General principles of biotechnological processes applied to the production of proteins for therapeutic use.
Molecular biotechnologies.
Legal and regulatory requirements for biologics (EMA, FDA). Good Manufacturing Practices (GMP) for biotechnology drugs.
Biological expression systems and selection criteria.
Master and Working Cell Banks.
Innovative processes and organization of industrial biological production.

Upstream processes and technological innovation: single use bioreactors
Downstream processing in biological production.
Classes of contaminants.
CMC factors, Immunogenicity. Aggregation. Glycosylation.

Biologicals approval as orphan drugs.
Biosimilars, biobetter and next generation biologicals.

Classes of biologics: Monoclonal antibodies, soluble receptors, cytokines, growth factors, enzymes, hormones.

Notes on the main classes of biotechnological drugs based on nucleic acids.
Planned learning activities and teaching methods: The teaching is based on lectures, literature search experiences on how to search the databases available for technical information, regulatory affairs and patents on biologics.

Besides lecturing, the course will use group works to stimulate soft skills, critical thinking, team work and peer evaluation. To that extent, students will be asked to prepare and present a Journal Club in class. A series of questionnaire on the group work will be provided to students to help them evaluate the group work.
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)
  • Walsh, Gary, Biopharmaceuticalsbiochemistry and biotechnologyGary Walsh. Chichester: Wiley, --. Cerca nel catalogo
  • Crommelin, Daan J. A.; Meibohm, Bernd, Pharmaceutical biotechnologyfundamentals and applicationsEditors Daan J. A. Crommelin, Robert D. Sindelar, Bernd Meibohm. New York: Springer, --. Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Lecturing
  • Problem based learning
  • Case study
  • Interactive lecturing
  • Working in group
  • Questioning
  • Peer feedback
  • Peer assessment
  • Auto correcting quizzes or tests for periodic feedback or exams
  • Active quizzes for Concept Verification Tests and class discussions
  • Use of online videos
  • Loading of files and pages (web pages, Moodle, ...)
  • Students peer review
  • Learning journal

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

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