First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
PHARMACEUTICAL BIOTECHNOLOGIES
Course unit
DIAGNOSTIC MICROBIOLOGY AND MOLECULAR IMMUNOLOGY
MEP5070485, A.A. 2017/18

Information concerning the students who enrolled in A.Y. 2016/17

Information on the course unit
Degree course Second cycle degree in
PHARMACEUTICAL BIOTECHNOLOGIES
ME2193, Degree course structure A.Y. 2015/16, A.Y. 2017/18
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Number of ECTS credits allocated 10.0
Type of assessment Mark
Course unit English denomination DIAGNOSTIC MICROBIOLOGY AND MOLECULAR IMMUNOLOGY
Department of reference Department of Pharmaceutical and Pharmacological Sciences
E-Learning website https://elearning.unipd.it/dsf/course/view.php?idnumber=2017-ME2193-000ZZ-2016-MEP5070485-N0
Mandatory attendance
Language of instruction English
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 ANTONELLA CAPUTO MED/07
Other lecturers SUSANNA MANDRUZZATO MED/04

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses MED/07 Microbiology and Clinical Microbiology 6.0
Core courses MED/04 General Pathology 4.0

Mode of delivery (when and how)
Period First semester
Year 2nd Year
Teaching method frontal

Organisation of didactics
Type of hours Credits Hours of
teaching
Hours of
Individual study
Shifts
Laboratory 1.0 15 10.0 No turn
Lecture 9.0 72 153.0 No turn

Calendar
Start of activities 02/10/2017
End of activities 19/01/2018

Examination board
Board From To Members of the board
2 Commissione a.a. 2017/18 01/12/2017 30/09/2018 CAPUTO ANTONELLA (Presidente)
FRASSON ILARIA (Membro Effettivo)
PROVVEDI ROBERTA (Supplente)

Syllabus
Prerequisites: Diagnostic microbiology

Basic microbiology: general properties of bacteria, viruses, mycetes, protozoa; basic concepts in immunology and molecular biology.

Molecular Immunology

Principles of Immunology
Target skills and knowledge: Diagnostic microbiology

This course is concerned with diagnostic microbiology in order to control microorganisms within the environment and hence from contaminating the biological product.
The main goal of this course is provide theoretical and practical information on pharmaceutical microbiology, including main diagnostics procedures, protocols and guidelines for the identification and characterisation of micro-organisms, elements that are necessary for the microbiological quality controls during development and manufacturing of biotechnological products.

Molecular Immunology

This course has a specific reference to the biotechnological research in the field of immunology and pharmacology. The student will obtain a number of information upon which he/she will be able to build a solid knowledge in these fields.
Examination methods: Diagnostic microbiology

The final exam consists of a written exam with questions that require short answers
The teacher will propose during the course different practical and theoretical activities that will contribute to the final grade .

Molecular Immunology

The final exam consists of multiple choice questions, or, in selected cases, oral exam.
Assessment criteria: Diagnostic microbiology

Written exam: 50% of the final mark.
Evaluation of the other activities: 50% of the final mark.

Molecular Immunology

Written exam: 100% of the final mark.
Course unit contents: Diagnostic microbiology

Microbiology and pharmaceuticals
GMP and regulations
Laboratory management and design
Microbiological culture media
Microbiology laboratory techniques
Bioburden determination
Specified and objectionable microorganisms
Microbial identification
Assessment of pharmaceutical water systems
Endotoxin and pyrogen testing
Sterilization and sterility assurance
Biological indicators: Measuring sterilization
Antibiotics and preservatives
Cleaning and disinfection
Cleanrooms and environmental monitoring
Rapid microbiological methods
Risk assessment
Manufacturing and validation
Microbiological data
Auditing the microbiology laboratory
Microbiological challenges to the pharmaceuticals and healthcare
Mycetes: general concepts and diagnostic methods
Viruses: Diagnostic methods

Molecular Immunology

Characteristics of the immune system. Innate and adaptive immunity. Identification of the pathogen by the cells of the innate system: PAMP and PRR. Toll-like receptors. Origin of the cells of the immune system. Recruitment of the leukocytes to the infection site. Natural killer cells and their role in the immune system.
Major histocompatibility complex: gene organization, protein structure and biological function. HLA typing.
Antibody structure. Monoclonal and polyclonal antibodies, generation of monoclonal antibody and their use in the lab and in the clinic. Evolution of monoclonal antibody. Monoclonal antibodies as drugs. B cell activation and antibody production: signal transduction and functional responses.
The innate response to viral infections.
Immunological tolerance: T Cell Development, Repertoire Selection and Immune Self Tolerance.
Transplantation immunology, Types of tranplant. Immune responses to allografts. Recognition of antigens, activation of alloreactive lymphocytes. Patterns and mechanisms of allograft rejection. Immunosuppressive drugs.
Maturation of T lymphocytes and signals for T cell activation. Balancing T cell activation and control. Functional responses of T lymphocytes: Th1, Th2, Th17. Decline of T cell responses.
Immunity to tumors. Immune responses to tumors. Tumor antigens. Evasion of immune responses by tumors. Immunotherapy for tumors. Recent advances in the immunotherapy of cancer.
Flow cytometry: principles and application in immunology
Planned learning activities and teaching methods: Diagnostic microbiology

The course is organised in lectures (40 hours) and laboratory activities (15 hours).
a. Frontal Lectures. The lectures, given by the teacher, will provide knowledge on the main diagnostics procedures and protocols, for identification and characterisation of micro-organisms, required for the microbiological quality controls during development and manufacturing of biotechnological products.
b. Group activities. Students will perform individual/group activities. To this purpose the teacher will provide recent articles on biotech problems or EMA guidelines. The students (in a small groups) have to analyze and develop the assigned topic and give a ppt oral presentation of his/her work to the other students. For this activity each student will receive a mark (that will contribute for 50% to the final mark).
c. Laboratory activities. The laboratory activities include the execution of diagnostic assays under the teacher’s guide.

Molecular Immunology

The course is organized in lectures (36 hours), including technical practical lessons.
a. Frontal lectures. The lectures, given by the teacher, are aimed at elucidating all the molecular mechanisms present in the program, with the help of the slides and a close interaction between the teacher and the students.
b. Technical practical lessons. During these lessons students will be given examples of several multiple choice question, similar to those of the final exam, that will be discussed between students and teacher.
Additional notes about suggested reading: Diagnostic microbiology

A copy of the power point slides will be handled to the students on Moodle.
Internet resources
http://www.who.int/en/ (OMS)
http://www.cdc.gov/az/a.html (Centers for disease control and prevention)
http://pathmicro.med.sc.edu/book/welcome.htm
http://www.doctorfungus.org/index.htm
http://www.ema.europa.eu/ (European Medicines Agency)
http://www.agenziafarmaco.gov.it/ (AIFA)
http://www.iss.it (Istituto Superiore di Sanità)
PubMed http://www.ncbi.nlm.nih.gov/sites/entrez
Google Scholar http://scholar.google.com/
HighWire at Stanford University http://highwire.stanford.edu/
BioMed Central http://www.biomedcentral.com
Public Library of Science PLoS http://plos.org
Howard Hughes Medical Institute www.hhmi.og
National Institute of Health www.nih.org

Molecular Immunology

Copy of the slides will be given to the students on the Moodle platform.
Textbooks (and optional supplementary readings)
  • Tim Sandle, Pharmaceutical microbiology. Essentials for quality assurance and quality controls. Cambridge UK: Woodhead Publishing Elsevier, 2015. Cerca nel catalogo
  • Connie R. Mahon MS MT(ASCP) CLS (Author), Donald C. Lehman EdD MT(ASCP) SM(NRM) (Author), George M, Textbook of Diagnostic Microbiology, 5e. www.amazon.com: Mahon, Textbook of Diagnostic Microbiology, 2014. Cerca nel catalogo
  • Eudes Lanciotti, Principi di Microbiologia clinica. Disponibile su www.amazon.com: Casa Editrice Ambrosiana 3° edizione, --. Cerca nel catalogo
  • A. K. Abbas,A. H. Lichtman,S. Pillai., Cellular and Molecular Immunology. 8th Edition, 2014: --, --. Cerca nel catalogo
  • K. Murphy P. Travers M. Walport, Janeway, Immunobiologia. --: --, 2011. Cerca nel catalogo
  • Doan.,Melvold, Viselli, Waltembaugh, Le basi dell’Immunologia. --: Zanichelli, 2009. Cerca nel catalogo