Quality Control and Analysis for Biopharmaceuticals
A.Y. 2025/2026
Learning objectives
This course provides the theory of the main analytical techniques applied for the characterization of biomolecules and biopharmaceuticals, along with the theory of the tests used to determine the biological activity of such products. The provides also the fundamentals of data interpretation, experimental design and methodology understanding.
Expected learning outcomes
At the end of the course the students are expected 1) to prove a basic knowledge of the principles of the most popular analytical techniques and biological activity tests applicable to biopharmaceuticals 2) to be able to figure out methodologies for the characterization of biopharmaceuticals; 3) to be able to understand the results obtained from instrumental analyses and biological activity tests performed on biopharmaceuticals; 4) to present clearly and with a proper language theoretical concepts and personal interpretation of the results; 5) to be able to write an analytical report and 6) to be able to refer to information sources.
Lesson period: First semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Single session
Responsible
Lesson period
First semester
Course syllabus
The course is divided into two teaching units: "Spectroscopic methods in bioorganic chemistry" and "Analytical and pharmacodynamic characterization of biopharmaceuticals".
Teaching unit "Spectroscopic methods in bioorganic chemistry"
- GENERAL PART: electromagnetic spectrum and electromagnetic radiation, characterization of electromagnetic radiation, electromagnetic radiation and interactions with matter, spectroscopic techniques.
- INFRARED SPECTROSCOPY: Basic principles: frequency of infrared absorption and chemical structure.
The IR spectrum. Characteristic absorption: hydrocarbons (alkanes, alkenes, alkynes, aromatics), alcohols, ethers, halides, carbonyl compounds, amines. IR spectrometers: classic, Fourier transform IR spectrophotometer (FT-IR). Reflection techniques: ATR, DRIFT, RAIRS. Applications of IR spectroscopy.
- NUCLEAR MAGNETIC RESONANCE, NMR (Nuclear Magnetic Resonance): general principles, properties of nuclei, magnetic field, and electromagnetic radiation (radiofrequency), the resonance phenomenon
Proton magnetic resonance: Chemical shift, Spin-spin coupling, Spin decoupling. Overhauser effect.
13C-NMR spectroscopy: Introduction. Carbon spectrum recording techniques. Chemical displacements. Spin 13C-1H coupling. DEPT and APT spectra. NMR correlation spectroscopy: 1H-1H COSY, 1H-13C HETCOR-HSQC-HMBC. NMR spectroscopy of other important nuclei 15N, 19F, 31P. Applications
- MASS SPECTROMETRY. Introduction. Instrumentation, introduction system, sources, analyzers. Low and high-resolution molecular ion. Molecular ion recognition. Examples of fragmentations and rearrangements..
Mass spectra of some chemical classes.
- CIRCULAR DICROISM: Introduction. Principles. Applications
- TECHNIQUES OF CHARACTERIZATION OF THE SOLID STATE: Differential Scanning Calorimetry and X-rays difractometry. Basic principles and applications.
For all the analytical techniques, problems in the area of biomolecule characterization will be addressed.
The teaching unit "Analytical and pharmacodynamic characterization of biopharmaceuticals" consists of two parts. The former concerns the structural characterization of biopharmaceuticals, whereas the letter concerns their pharmacodynamic characterization.
The structural characterization of latest generation biopharmaceuticals will be taught using as educational example the characterization of antibody-drug conjugates (ADCs) as a comprehensive educational path to teach the most popular analytical techniques and methodological approaches. The program will include the fundamentals of:
- Chromatography (high performance liquid chromatography)
- Electrophoresis (gel and capillary electrophoresis)
- UV-Vis spectroscopy (absorption and emission techniques)
- Mass spectrometry (ESI and MALDI ionization)
The fundamentals of hyphenation of such analytical techniques and the principles of sample preparation and purification necessary for sample analysis will be discussed as well.
Given the critical role of assessing the biological activity of biotechnological drugs in ensuring quality throughout the entire production process, the pharmacodynamic characterization section will address the following topics:
- Use of in vitro and in vivo models in development, production, and quality control
- Generation and use of recombinant cell lines in the production process and cell banking
- Identification of microbiological contamination, endotoxins, and host cell proteins
- Use and validation of binding assays and potency assays to study biological activity
- Use of specific assays for determining the potency of monoclonal antibodies and vaccines
- Consultation of official reports on biotechnological drugs in databases, identification of critical quality attributes, production process steps, and bioassays used in manufacturing and quality control.
Teaching unit "Spectroscopic methods in bioorganic chemistry"
- GENERAL PART: electromagnetic spectrum and electromagnetic radiation, characterization of electromagnetic radiation, electromagnetic radiation and interactions with matter, spectroscopic techniques.
- INFRARED SPECTROSCOPY: Basic principles: frequency of infrared absorption and chemical structure.
The IR spectrum. Characteristic absorption: hydrocarbons (alkanes, alkenes, alkynes, aromatics), alcohols, ethers, halides, carbonyl compounds, amines. IR spectrometers: classic, Fourier transform IR spectrophotometer (FT-IR). Reflection techniques: ATR, DRIFT, RAIRS. Applications of IR spectroscopy.
- NUCLEAR MAGNETIC RESONANCE, NMR (Nuclear Magnetic Resonance): general principles, properties of nuclei, magnetic field, and electromagnetic radiation (radiofrequency), the resonance phenomenon
Proton magnetic resonance: Chemical shift, Spin-spin coupling, Spin decoupling. Overhauser effect.
13C-NMR spectroscopy: Introduction. Carbon spectrum recording techniques. Chemical displacements. Spin 13C-1H coupling. DEPT and APT spectra. NMR correlation spectroscopy: 1H-1H COSY, 1H-13C HETCOR-HSQC-HMBC. NMR spectroscopy of other important nuclei 15N, 19F, 31P. Applications
- MASS SPECTROMETRY. Introduction. Instrumentation, introduction system, sources, analyzers. Low and high-resolution molecular ion. Molecular ion recognition. Examples of fragmentations and rearrangements..
Mass spectra of some chemical classes.
- CIRCULAR DICROISM: Introduction. Principles. Applications
- TECHNIQUES OF CHARACTERIZATION OF THE SOLID STATE: Differential Scanning Calorimetry and X-rays difractometry. Basic principles and applications.
For all the analytical techniques, problems in the area of biomolecule characterization will be addressed.
The teaching unit "Analytical and pharmacodynamic characterization of biopharmaceuticals" consists of two parts. The former concerns the structural characterization of biopharmaceuticals, whereas the letter concerns their pharmacodynamic characterization.
The structural characterization of latest generation biopharmaceuticals will be taught using as educational example the characterization of antibody-drug conjugates (ADCs) as a comprehensive educational path to teach the most popular analytical techniques and methodological approaches. The program will include the fundamentals of:
- Chromatography (high performance liquid chromatography)
- Electrophoresis (gel and capillary electrophoresis)
- UV-Vis spectroscopy (absorption and emission techniques)
- Mass spectrometry (ESI and MALDI ionization)
The fundamentals of hyphenation of such analytical techniques and the principles of sample preparation and purification necessary for sample analysis will be discussed as well.
Given the critical role of assessing the biological activity of biotechnological drugs in ensuring quality throughout the entire production process, the pharmacodynamic characterization section will address the following topics:
- Use of in vitro and in vivo models in development, production, and quality control
- Generation and use of recombinant cell lines in the production process and cell banking
- Identification of microbiological contamination, endotoxins, and host cell proteins
- Use and validation of binding assays and potency assays to study biological activity
- Use of specific assays for determining the potency of monoclonal antibodies and vaccines
- Consultation of official reports on biotechnological drugs in databases, identification of critical quality attributes, production process steps, and bioassays used in manufacturing and quality control.
Prerequisites for admission
Knowledge of the fundamentals of physics, chemistry, organic chemistry, biochemistry, and pharmacology.
Teaching methods
The teaching unit "Spectroscopic Methods in Bioorganic Chemistry" is organized as classroom lectures, for which attendance is recommended. Group and individual work involving case studies focused on reading and interpreting spectra, as well as confirming the structure of simple organic molecules, will be discussed during the lectures. The course may combine in-person teaching with both synchronous and asynchronous online components.
The teaching unit "Analytical and Pharmacodynamic Characterization of Biopharmaceuticals" is delivered by two lecturers through classroom lectures, where topics are presented using both slides and exercises on the blackboard. Attendance is strongly encouraged. To foster student engagement, some topics are taught using flipped classrooms, breakout rooms, interactive live quizzes, and Q&A sessions.
The teaching unit "Analytical and Pharmacodynamic Characterization of Biopharmaceuticals" is delivered by two lecturers through classroom lectures, where topics are presented using both slides and exercises on the blackboard. Attendance is strongly encouraged. To foster student engagement, some topics are taught using flipped classrooms, breakout rooms, interactive live quizzes, and Q&A sessions.
Teaching Resources
Lecture slides and supplementary teaching materials will be made available on the MyAriel platform.
- R.M. Silverstein, F.X. Webster Identificazione spettrometrica di composti organici Terza edizione-Casa Editrice Ambrosiana.
- Structure determination of organic compounds, practical exercises E. Rossi, D. Nava, G. Abbiati, G. Celentano, S. Pandini. Casa Editrice Edises
- A. Randazzo. Guida pratica all'interpretazione di spettri NMR. Casa Editrice Loghia
- Antibody-Drug Conjugates, Methods and Protocols, edited by L. Nathan Tumey (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.
- R.M. Silverstein, F.X. Webster Identificazione spettrometrica di composti organici Terza edizione-Casa Editrice Ambrosiana.
- Structure determination of organic compounds, practical exercises E. Rossi, D. Nava, G. Abbiati, G. Celentano, S. Pandini. Casa Editrice Edises
- A. Randazzo. Guida pratica all'interpretazione di spettri NMR. Casa Editrice Loghia
- Antibody-Drug Conjugates, Methods and Protocols, edited by L. Nathan Tumey (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.
Assessment methods and Criteria
For the teaching unit "Spectroscopic Methods in Bioorganic Chemistry," the exam consists of a two-hour written test comprising a theoretical question aimed at assessing the student's understanding of the spectroscopic techniques presented during the course, and an exercise involving the interpretation of spectral data for an organic molecule with a known structure. This exercise is designed to evaluate the student's ability to apply their acquired knowledge and understanding to the analysis of spectroscopic data and to justify the reasoning process followed. The test is considered passed if the student obtains a minimum score of 18/30 in both parts. The results, published on the University platform, will then be discussed in an individual interview.
For the teaching unit "Analytical and Pharmacodynamic Characterization of Biopharmaceuticals," the exam consists of a single two-hour written test with open-ended questions covering both the analytical and pharmacodynamic components of the course. The evaluation criteria include assessment of the student's knowledge of the fundamentals of biopharmaceutical analysis and biological activity measurement. The written test also assesses the ability to interpret analytical results and to design an appropriate analytical strategy for a given biopharmaceutical product.
The final grade will be calculated as the CFU-weighted average of the individual module grades.
For the teaching unit "Analytical and Pharmacodynamic Characterization of Biopharmaceuticals," the exam consists of a single two-hour written test with open-ended questions covering both the analytical and pharmacodynamic components of the course. The evaluation criteria include assessment of the student's knowledge of the fundamentals of biopharmaceutical analysis and biological activity measurement. The written test also assesses the ability to interpret analytical results and to design an appropriate analytical strategy for a given biopharmaceutical product.
The final grade will be calculated as the CFU-weighted average of the individual module grades.
BIO/14 - PHARMACOLOGY - University credits: 3
CHIM/06 - ORGANIC CHEMISTRY - University credits: 3
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 3
CHIM/06 - ORGANIC CHEMISTRY - University credits: 3
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 3
Lessons: 72 hours
Professor(s)
Reception:
Request an appointment by email
Office in Via Balzaretti 9 (3rd floor)
Reception:
By appointment
Via Golgi 19. Building 25010-Entrance C, IV floor
Reception:
on demand, to be scheduled via email
Via L. Mangiagalli 25, first floor, room 1044