Analytical Methods for Pharmaceutical Biotechnologies
A.Y. 2024/2025
Learning objectives
The primary objective of this course is to introduce the basic concepts, principles, and techniques of modern analytical chemistry that would provide students with an analytical mind shape and abilities to solve diverse analytical problems, involved in the pharmaceutical biotechnologies, in an efficient, quantitative and qualitative way. One of the aim is to provide to the students adequate preparation in order to identify the different components of the drug, both at the production and at the final stages, that conveys the importance of accuracy and precision of the analytical results.
Expected learning outcomes
On successful completion of this course, students will be able to:
1)to understand the different analytical methods in chemistry.
2)to establish an appreciation of the role of chemistry in quantitative analysis
3)to understand the broad role of the chemist in measurement and problem solving for analytical tasks.
4)to understand the different chemical methods employed for elemental and compound analysis.
1)to understand the different analytical methods in chemistry.
2)to establish an appreciation of the role of chemistry in quantitative analysis
3)to understand the broad role of the chemist in measurement and problem solving for analytical tasks.
4)to understand the different chemical methods employed for elemental and compound analysis.
Lesson period: Second semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Single session
Responsible
Lesson period
Second semester
Course syllabus
The topics included in the module "Elementi di chimica analitica e strumentale" are:
-Analytical Chemistry: basic concepts
- Ionic atmosphere, Ionic equilibria in aqueous solutions, ionic strength, activity coefficients, Debye-Huckel equation, Le Chatelier principle
- Principles of electrochemical thermodynamic
- Acid-base equilibrium: buffers, buffer capacity, indicators
- Coordination compounds.
- Oxidation/reduction reactions: electrode potentials, Nernst equation
- Volumetric titrations (precipitation, acid-base, complex formation, oxidation/reduction)
- Potentiometric methods: junction potential, reference and indicator electrodes, calibration, membrane potential, transference numbers
- Potentiometric titrations
- Conductimetry and related titrations
For the module "Analisi dei farmaci biotecnologici" the topic of characterization of antibody-drug conjugates (ADCs) will be used as a "comprehensive educational path" to teach the most popular analytical techniques and the methodological approaches used for the characterization of latest generation biopharmaceuticals by:
-Liquid chromatography
-Gel and capillary electrophoresis
-Absorption and emission UV-Visible spectroscopy
-Mass spectrometry
Fundamentals of:
-Hyphenation of the analytical techniques
-Sample preparation and purification
will be treated as well.
-Analytical Chemistry: basic concepts
- Ionic atmosphere, Ionic equilibria in aqueous solutions, ionic strength, activity coefficients, Debye-Huckel equation, Le Chatelier principle
- Principles of electrochemical thermodynamic
- Acid-base equilibrium: buffers, buffer capacity, indicators
- Coordination compounds.
- Oxidation/reduction reactions: electrode potentials, Nernst equation
- Volumetric titrations (precipitation, acid-base, complex formation, oxidation/reduction)
- Potentiometric methods: junction potential, reference and indicator electrodes, calibration, membrane potential, transference numbers
- Potentiometric titrations
- Conductimetry and related titrations
For the module "Analisi dei farmaci biotecnologici" the topic of characterization of antibody-drug conjugates (ADCs) will be used as a "comprehensive educational path" to teach the most popular analytical techniques and the methodological approaches used for the characterization of latest generation biopharmaceuticals by:
-Liquid chromatography
-Gel and capillary electrophoresis
-Absorption and emission UV-Visible spectroscopy
-Mass spectrometry
Fundamentals of:
-Hyphenation of the analytical techniques
-Sample preparation and purification
will be treated as well.
Prerequisites for admission
Knowledge of the fundamentals of chemistry, organic chemistry, physics, and biochemistry.
Teaching methods
The course is divided into classroom lectures, in which the topics are illustrated both with slides and by carrying out exercises on the blackboard. At the end of the course, an educational experimental laboratory is organized in which the students, organized in small groups, carry out four different experiences concerning both traditional and instrumental quantitative analysis.
Teaching Resources
Skoog, West, Holler, Crouch, Fondamenti di Chimica Analitica. EdiSES. (3° ed. italiana 2015)
Antibody-Drug Conjugates, Methods and Protocols, edited by L.NathanTumey (2020), ebook available at the university online library service, ISBN: 1-4939-9929-X; 1-4939-9928-1.
Analytical Characterization of Biotherapeutics (capitoli 1,2 e 7), edited by Jennie R. Lill and Wendy Sandoval (2017), ebook available at the university online library service, ISBN: 1-119-38442-7; 1-119-38443-5; 1-119-05310-2.
Slides of the lessons available on Ariel website of the course
Antibody-Drug Conjugates, Methods and Protocols, edited by L.NathanTumey (2020), ebook available at the university online library service, ISBN: 1-4939-9929-X; 1-4939-9928-1.
Analytical Characterization of Biotherapeutics (capitoli 1,2 e 7), edited by Jennie R. Lill and Wendy Sandoval (2017), ebook available at the university online library service, ISBN: 1-119-38442-7; 1-119-38443-5; 1-119-05310-2.
Slides of the lessons available on Ariel website of the course
Assessment methods and Criteria
The knowledge of the topics reported in the course's program will be evaluated by means of a two hours-written test consisting of two questionnaires.
The first questionnaire is aimed at verifying the knowledge of the topics concerning the module of "Elementi di chimica analitica strumentale" and the second questionnaire is aimed at verifying the knowledge of the topics concerning the module of "Analisi dei farmaci biotecnologici".
In the first questionnaire the student is asked to solve one-to-two exercises and answer three-to-four theory questions. In the second questionnaire the student is asked to answer five theory questions, five questions concerning analytical approaches for the characterization of biopharmaceuticals and five questions concerning the interpretation of data collected from instrumental analysis of biopharmaceuticals.
The final course's grade will be the arithmetic mean of the grades of the two questionnaires.
The first questionnaire is aimed at verifying the knowledge of the topics concerning the module of "Elementi di chimica analitica strumentale" and the second questionnaire is aimed at verifying the knowledge of the topics concerning the module of "Analisi dei farmaci biotecnologici".
In the first questionnaire the student is asked to solve one-to-two exercises and answer three-to-four theory questions. In the second questionnaire the student is asked to answer five theory questions, five questions concerning analytical approaches for the characterization of biopharmaceuticals and five questions concerning the interpretation of data collected from instrumental analysis of biopharmaceuticals.
The final course's grade will be the arithmetic mean of the grades of the two questionnaires.
CHIM/01 - ANALYTICAL CHEMISTRY - University credits: 4
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 3
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 3
Single bench laboratory practical: 16 hours
Lessons: 48 hours
Lessons: 48 hours
Professors:
Altomare Alessandra Anna, Arnaboldi Serena
Shifts:
Professors:
Altomare Alessandra Anna, Arnaboldi Serena
Turno 1
Professor:
Arnaboldi SerenaTurno 2
Professor:
Arnaboldi SerenaProfessor(s)