Analytical and Formulation Strategies in Biotechnological Drug Discovery
A.Y. 2025/2026
Learning objectives
The course aims at providing knowledge of the general principles and requirements for the design, development and formulation of new biotechnological medicinal products. The main bioanalysis and formulation techniques used in this field will be covered, providing the theoretical basis for planning and performing analyses aimed at evaluating pharmacokinetics, stability, and potential off-target effects, as well as for interpreting the results obtained. Regulatory aspects related to clinical trials and obtaining the Marketing Authorisation (MA) of new biotechnological medicinal products will also be examined.
Expected learning outcomes
At the end of the course, the student will acquire principles required to design biotechnological medicinal products, based on the specific properties of the active substance and the therapeutic requirements. Specifically, the student will be expected to: 1) prove a basic knowledge of the principles of the analytical and formulation techniques disclosed into the course 2) be able to figure out methodologies for the design, formulation and characterization of biopharmaceuticals; 3) be able to understand the results obtained from instrumental analyses; 4) clearly present and with a proper language theoretical concepts and personal interpretation concerning the topics disclosed into the course and 5) be able to refer to technical, scientific and regulatory sources related to the topics covered in the course.
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 aim of the course is to provide knowledge of the general principles and requirements for the design, development, and formulation of new biotechnological medicinal products. The course covers the main bioanalytical techniques and formulation strategies used in this field, offering the theoretical foundations necessary for planning and conducting pharmacokinetic and stability studies, as well as for assessing potential off-target effects and critically interpreting experimental results. Regulatory aspects related to clinical trials and the obtainment of Marketing Authorisation (MA) for biotechnological medicinal products will also be addressed.
Topics covered in the two modules:
- Introduction to biotechnological medicinal products
- Analytical strategies: bioanalytical techniques applied to biotechnological products
- Formulation strategies for the development of biotechnological medicinal products
- Evaluation of off-target effects and advanced characterization
- Regulatory and authorisation aspects
- Case studies and practical applications
Topics covered in the two modules:
- Introduction to biotechnological medicinal products
- Analytical strategies: bioanalytical techniques applied to biotechnological products
- Formulation strategies for the development of biotechnological medicinal products
- Evaluation of off-target effects and advanced characterization
- Regulatory and authorisation aspects
- Case studies and practical applications
Prerequisites for admission
In order to ensure an adequate level of learning, students are expected to have prior knowledge of general and inorganic chemistry, stoichiometry, analytical chemistry, and organic chemistry. Given the multidisciplinary nature of the course, a solid understanding of physiology and general pharmacology is also essential. A basic knowledge of pharmaceutical technology is recommended. Some of these topics will be briefly reviewed at the beginning of the course.
Teaching methods
The course is structured as in-class lectures, during which the topics are presented and explored in depth using slides and other teaching materials that support the explanation.
Teaching Resources
The teaching material includes the slides presented during the lectures, which are made available in PDF format on the ARIEL platform of the University of Milan. All content provided during the lessons and uploaded to ARIEL constitutes the basis for exam preparation.
A recommended reference textbook is:
P. Minghetti - Legislazione Farmaceutica, CEA Editrice, 9th edition, 2018.
A recommended reference textbook is:
P. Minghetti - Legislazione Farmaceutica, CEA Editrice, 9th edition, 2018.
Assessment methods and Criteria
he exam consists of two oral tests based on questions concerning theoretical aspects covered during the course. The aim is to assess the student's knowledge and understanding of the topics, as well as their ability to present them clearly and coherently. In order to pass the exam, a minimum score of 18/30 must be achieved for each question. The assessment focuses on the principles and general requirements for the design, development, and formulation of biotechnological drugs, the main bioanalytical techniques with their theoretical foundations for planning and conducting pharmacokinetic, stability, and off-target effect studies, as well as the regulatory aspects related to clinical trials and the obtainment of Marketing Authorization (MA).
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 4
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Single bench laboratory practical: 16 hours
Lessons: 56 hours
Lessons: 56 hours
Professors:
Anderluzzi Giulia, Minghetti Paola
Professor(s)