First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Science
INDUSTRIAL BIOTECHNOLOGY
Course unit
DEVELOPMENT OF BIOTECHNOLOGICAL DRUGS
SCP9088079, A.A. 2019/20

Information concerning the students who enrolled in A.Y. 2019/20

Information on the course unit
Degree course Second cycle degree in
INDUSTRIAL BIOTECHNOLOGY
SC1731, Degree course structure A.Y. 2014/15, A.Y. 2019/20
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Number of ECTS credits allocated 6.0
Type of assessment Mark
Course unit English denomination DEVELOPMENT OF BIOTECHNOLOGICAL DRUGS
Website of the academic structure http://biotecnologie.scienze.unipd.it/2019/laurea_magistrale
Department of reference Department of Biology
Mandatory attendance
Language of instruction Italian
Branch PADOVA
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

Lecturers
Teacher in charge VALENTINA GANDIN CHIM/08
Other lecturers EMANUELE PAPINI MED/04

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Educational activities in elective or integrative disciplines CHIM/08 Pharmaceutical Chemistry 1.0
Educational activities in elective or integrative disciplines MED/04 General Pathology 1.0
Core courses CHIM/08 Pharmaceutical Chemistry 2.0
Core courses MED/04 General Pathology 2.0

Course unit organization
Period Second semester
Year 1st Year
Teaching method frontal

Type of hours Credits Teaching
hours
Hours of
Individual study
Shifts
Lecture 6.0 48 102.0 No turn

Calendar
Start of activities 02/03/2020
End of activities 12/06/2020
Show course schedule 2019/20 Reg.2014 course timetable

Examination board
Examination board not defined

Syllabus
Prerequisites: Students are expected to have basic knowledge of chemistry, molecular biology, biochemistry and of general immunology.
Target skills and knowledge: The aims of the course is to provide students with the basic knowledge on the development of biotechnological drugs. Specifically, at the end of the course the student must know:

1) the fundamental stages of the industrial process for development, production and control of biotechnological drugs
2) the main problems encountered during the development of a biotechnological drug
3) the characteristics of the main classes of biotechnological drugs currently in use and the latest developments in the field
Examination methods: Written exam with open and multiple choice questions
Assessment criteria: The examination at the end of the course aims to test student knowledge and understanding of all aspects related to the discovery and development of a biotechnological drug.
Course unit contents: - Pharmaceutical Glossary: definition of drug and medicinal product, Italian and European Official Pharmacopoeia, pharmacokinetic and pharmacodynamics, toxicological-pharmaceutical chemistry.
- Drug development process, similarities/differences between biotechnological drugs and "small-molecules". Reference standard for biotechnological drugs (EMA, FDA), main international guidelines of reference (ICH) in drug discovery, drug development and developability processes. Biosimilars and biobetters.
- Purity, chemical, physical and microbiological stability for biotechnological drugs: reference legislation, evaluation tests and the role of formulation.
- Main classes of biotechnological drugs (therapeutic proteins, biotechnologicals based on nucleic acids, monoclonal antibodies and their engineered products such as teranostics, conjugated antibodies and active ingredients or for the detection-immunotoxins).
- Recent developments regarding optimization strategies of pharmacokinetic and pharmacodynamic profiles of biotechnological drugs currently in therapy (lead improvment).
- Biocompatibility and interaction with innate and adaptive immune humoral and cellular reactive systems of biotechnological drugs or their nano-formulations. Anti-drug antibodies, coagulation complement activation and plasminogen cascade. Approaches to induce stealth properties in biotechnological drugs.
- Animal models and species specificity of interaction between biotechnological drugs and prevalent preclinical models (murine, swine).
Planned learning activities and teaching methods: Lectures and group works. The teaching activity will be interactive and, by means of questioning and case report presentations, critical thinking and discussions will be promoted.
Textbooks (and optional supplementary readings)
  • 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
  • Case study
  • Interactive lecturing
  • Working in group
  • Questioning
  • Auto correcting quizzes or tests for periodic feedback or exams
  • Use of online videos

Innovative teaching methods: Software or applications used
  • Top Hat (active quiz, quiz)