Production, Legislation and Marketing of Biotechnological Medicines
A.Y. 2025/2026
Learning objectives
The course is intended to cover principles and general requirements for the development of biotechnological medicinal products, from biopharmaceutics to the manufacturing of the final dosage form. References are made to the quality assays, compendial and not, to characterize the finished medicinal products Regulatory aspects relevant to production and marketing are also addressed.
Expected learning outcomes
At the end of the course, students are expected to know the relation among the specific properties of an active substance, dosage form, administration site and the therapeutic requirements in order to formulate a medicinal product complying the requirements of quality, safety and efficacy. Starting from the main chemical-physical characteristics of the active substance, the student will be able to propose the most suitable route of administration, manufacturing methods for biotechnological and advanced therapy medicinal products to according to the Good Manufacturing Practices.
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
- Industrial processes to manufacture biotechnology drugs;
- Organization of a pharmaceutical plant with emphasis on biotechnology products;
- Advanced and cell therapies;
- Regulatory aspects, according to EU regulations.
- Organization of a pharmaceutical plant with emphasis on biotechnology products;
- Advanced and cell therapies;
- Regulatory aspects, according to EU regulations.
Prerequisites for admission
The course allows students to gain knowledge of the production processes of biotechnology drugs, either conventional and non-conventional (injectable products, liposomes, nanotechnologies) or for advanced therapy. Regulatory topics (e.g., CTD, variations, GMP, quality risk management, patents) and topics related to the pharma/biopharma industry (e.g., technology transfer, pharmacovigilance, safety in the workplace) are also covered. Therefore, in order to profitably attend and pass the exam, the students should have basic knowledge of organic chemistry, physical chemistry, analytical chemistry, and pharma regulations.
Teaching methods
Classes and a visit to a biotechnology company. The lessons are held with the aid of experts in the field, both with an academic (Milan University) and industrial background. Attendance at classes is recommended and will be taken into consideration in the final evaluation of the student. The visit to a biotechnology company includes an initial oral presentation given by the company staff, which illustrates the company's main objectives, technical capabilities and activities. A guided tour of the production plant follows. After the visit there is a question & answer session with the company staff.
Teaching Resources
The slides presented during the lessons are available in myAriel.
Assessment methods and Criteria
The exam consists of an oral test concerning the topics covered in classes and an oral presentation (dissertation) drafted by the students.
For the latter, students will have to form working groups (ideally 2-4 persons) and propose and agree with the teacher a technological topic related to subjects of the course program.
The dissertation, which will last 40-60 minutes, will give each member of the working group the opportunity to present for about 10-20 minutes. The last slide will have to report references to both literature papers (at least 3-4) and regulatory websites (e.g., EMA and / or FDA) that the working group considered for the dissertation. The slides will preferably be in English. The oral presentation can be in Italian.
The oral exam, which will focus more specifically on topics covered in the lessons, will follow and can be taken on the same day as the dissertation or on a subsequent day.
The evaluation of both the oral exam and the dissertation, and the students' attendance at the course lessons (at least 60-70%) contribute to the final grade. The dissertation has the greatest impact on the final grade. Typically, the evaluation score for dissertation, oral exam and attendance will be 50, 30 and 20% respectively. If the dissertation is considered excellent, its evaluation score may increase. The assessment will be based on the ability to organize the speech and to carry out a critical reasoning on the study carried out and presented, as well as the competence in the use of specific vocabulary.
For the latter, students will have to form working groups (ideally 2-4 persons) and propose and agree with the teacher a technological topic related to subjects of the course program.
The dissertation, which will last 40-60 minutes, will give each member of the working group the opportunity to present for about 10-20 minutes. The last slide will have to report references to both literature papers (at least 3-4) and regulatory websites (e.g., EMA and / or FDA) that the working group considered for the dissertation. The slides will preferably be in English. The oral presentation can be in Italian.
The oral exam, which will focus more specifically on topics covered in the lessons, will follow and can be taken on the same day as the dissertation or on a subsequent day.
The evaluation of both the oral exam and the dissertation, and the students' attendance at the course lessons (at least 60-70%) contribute to the final grade. The dissertation has the greatest impact on the final grade. Typically, the evaluation score for dissertation, oral exam and attendance will be 50, 30 and 20% respectively. If the dissertation is considered excellent, its evaluation score may increase. The assessment will be based on the ability to organize the speech and to carry out a critical reasoning on the study carried out and presented, as well as the competence in the use of specific vocabulary.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 7
Lessons: 56 hours
Professors:
Maroni Alessandra, Palugan Luca
Professor(s)
Reception:
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71