Analytical methods for pharmaceutical biotechnologies

A.Y. 2019/2020
Overall hours
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.
Course syllabus and organization

Single session

Lesson period
First semester
Course syllabus
The topics included in the module "Elementi di chimica analitica e strumentale" are:
- Ionic equilibria in aqueous solutions, ionic strength, activity coefficients, Debye-Huckel equation
- Acid-base equilibrium: buffers, buffer capacity, indicators
- Systematic method for performing equilibrium calculations
- Amminoacids: isoionic and isoelectric point
- Coordination compounds.
- Oxidation/reduction reactions: electrode potentials, Nerst equation
- Volumetric titrations (precipitation, acid-base, complex formation, oxidation/reduction)
- Potentiometric methods : junction potential, reference and indicator electrodes, calibration, direct methods
- Potentiometric titrations
- Spectrophotometric methods, the electromagnetic radiation and the light/matter interaction, absorption spectroscopy, chromophores, Lambert-Beer equation
- Spectrophotometric titrations
- Emission spectroscopy
- Fluorescence methods: fluorescent probe for cell imaging, chemiluminescent methods
- A short introduction on Nuclear Magnetic Resonance

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, namely:
-Chromatographic techniques
-Electrophoretic techniques (gel and capillary electrophoresis)
-Absorption and emission UV-Vis spectroscopy
-Mass spectrometry
-Principles of hyphenation of the analytical techniques
-Principles of sample preparation and purification
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)

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 four-to-five exercises and answer a theory question. 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: 0
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 0
Lessons: 24 hours
CHIM/01 - ANALYTICAL CHEMISTRY - University credits: 0
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 0
Single bench laboratory practical: 16 hours
Lessons: 24 hours
Turno 2
Professor: Longhi Mariangela
By appointment
Department of Chemistry, via Golgi 19 - Milano
From Monday to Friday, between 8.30 and 18.30, by appointment (to be requested by email))
Normally in my office (Chemistry Department, West Wing, First Floor). Currently, on account of the pandemy, on the Teams platform in videoconference mode.
on demand, to be scheduled via email
Via L. Mangiagalli 25, first floor, room 1066