Degree course: 
Corso di Second cycle degree in Biotechnology for the Bio-based and Health Industry
Academic year when starting the degree: 
Academic year in which the course will be held: 
Course type: 
Compulsory subjects, characteristic of the class
Second semester
Standard lectures hours: 
Detail of lecture’s hours: 
Lesson (48 hours)

Knowledge of organic chemistry (basic reactions) and analytical techniques (basic) are required

Final Examination: 

The objective of the exam is to verify the level of achievement of the indicated training objectives.
The exam is carried out in written form and consists of:

• 15 main questions (possibly divided into sub-questions) with multiple answers (11 points)
• 2 open questions (answer in the form of a text-reports) which concern the program described above (11 points each)

The final grade is expressed out of thirty.
The sum of the scores of all the questions is equal to 33 (corresponding to an evaluation of 30L).
For each question the degree of understanding and the ability to explain the basic principle and the student's ability to illustrate the subject through examples are assessed (the ability to correctly represent reactions, chemical structures and graphics is considered).
The student will be notified of the vote and judgment by returning the written note with the annotations referring to the course content.
In the case of an incorrectly described or inaccurate answer that denote the lack of knowledge of a part of the subject, the possibility is given to recover that deficient part through an oral interview in the subsequent appeal or on a date to be agreed. The vote of the oral exam will replace the one of the written answer.

Voto Finale

The main objective of the course is to provide basic knowledge on the synthesis of drugs, their discovery, industrial development with reference to the processes of quality and industrial safety. The production strategies from the laboratory to production will be analyzed, as well as the factors that influence their activity, in particular with reference to their potential applications in the pharmaceutical field.
At the end of the course, the student will be able to:

• Explain strategies for the synthesis of new drugs.
• Describe the different molecular mechanisms of synthesis and analysis of the active ingredients.
• Correlate the main chemical / physical factors that influence the synthesis and analysis with particular reference to the processes of Quality and Industrial Safety
• Critically discuss the research and development mechanism of a drug with the analytical support of techniques suitable for distinguishing the active ingredient, metabolites and impurities deriving from the synthesis.
• Correctly represent reactions, chemical structures, industrial evolution of a drug in the logic of good manufacturing practices.
• Describe a process of synthesis of a drug from research to production considering all the phases through which a new product must follow to be placed on the market.

Knowledge of organic chemistry (basic reactions) and analytical techniques (basic) are required

The course is divided into:
48 hours (6 credits) of lectures dealing with the following topics:

• Principles of research and development of synthetic and semi-synthetic drugs

• Synthetic derivatives from natural product (fermentation, antitumoral, alkaloid, etc)

• Combinatorial chemistry strategies, one-pot synthesis, click chemistry, bio catalysis for drug identification and modification. Design of Experiment (DOE)

• Analytical technologies (on-line and off- line methodologies)

• Quality by Design (QB) and Process Analytical Technologies (PAT)

• Good Manufacturing Process, ICH guideline, Regulatory Compliance (AIFA, EMA, FDA)

• From the Lab to the production (Scale-up, Hazard assessment, Safety, Environmental Impact, Waste treatment, etc..)


The course consists of 36 hours of frontal lessons (18 lessons).
During each lesson a topic is treated starting from the discussion of the general theoretical principles, illustrating some examples (also taken from recent literature) and discussing potential implications from the applicative point of view. The lessons are supported by PowerPoint slides (also available on the e-learning platform).
After a general introduction to illustrate the objectives and experimental methods, students will be encouraged to independently look for the examples reported in literature.

The teacher is available to provide information on the course and topics by appointment via e-mail (requests must be made by email – marino.nebuloni@uninsubria.it from the domain @ students.uninsubria.it).
The teacher is available for any in-depth or clarification meetings on the topics covered.