Manufacturing of Biotechnological Drug Products
A.Y. 2023/2024
Learning objectives
This course aims to provide students with knowledge on the following topics:
- industrial processes used in the production of medicinal products of biotechnological origin;
- organization of manufacturing in a pharmaceutical company with specific reference to the production of finished products containing substances of biotechnological origin;
- cell therapy and advanced therapy medicinal products;
- legislative framework defining the requirements necessary for marketing application of medicinal products according to EC regulations.
- industrial processes used in the production of medicinal products of biotechnological origin;
- organization of manufacturing in a pharmaceutical company with specific reference to the production of finished products containing substances of biotechnological origin;
- cell therapy and advanced therapy medicinal products;
- legislative framework defining the requirements necessary for marketing application of medicinal products according to EC regulations.
Expected learning outcomes
At the end of the course, the student will acquire the necessary knowledge to understand the preparation processes of the biotechnology products, both based on proteins and monoclonal antibodies and belonging to the category of the Advanced Therapy Medicinal Products (ATMPs), i.e., based on genes and cells. The student will also acquire basic technological knowledge related to unconventional products, such as liposomes, complex generics and nano-systems. The student will also learn about the organization of a pharmaceutical industry and regulatory aspects of the aforementioned products.
Based on this competence, the student will be able to apply the knowledge acquired to understand and identify the critical aspects, both technology- and regulatory-related, of the biotechnology products.
Based on this competence, the student will be able to apply the knowledge acquired to understand and identify the critical aspects, both technology- and regulatory-related, of the biotechnology products.
Lesson period: First semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Single session
Responsible
Lesson period
First semester
Course syllabus
The course objectives are to provide the students with the knowledge of:
- industrial processes to manufacture biotechnology drugs;
- organization of a Pharmaceutical plant with emphasis to biotechnology products;
- advanced and cell therapies;
- regulatory aspects, according to EU regulations.
- industrial processes to manufacture biotechnology drugs;
- organization of a Pharmaceutical plant with emphasis to 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, both traditional and advanced (injectable products, liposomes, nanotechnologies) and advanced therapy. Topics of regulatory nature (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 follow the lessons successfully and pass the exam, the students should have the basic knowledge of organic chemistry, physical chemistry, analytical chemistry, and pharma regulations.
Teaching methods
Classroom lessons and visit to a biotechnology company. The lessons are held by various teachers, both from an academic (Milan University) and industrial background. The latter are professionals who have acquired considerable experience and knowledge in the subjects of their lectures. Attendance of the lessons 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 department 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 Ariel.
Assessment methods and Criteria
The exam consists of an oral test concerning the topics covered in classand an oral presentation (thesis) prepared by the students.
For the thesis, students will have to form working groups (ideally 2-4 people, but if necessary also one or 5 people) and propose to and agree with the teacher a technical / technological topic related to the themes of the course program.
The thesis, which will last 40-60 minutes, will give each member of the working group the opportunity to speak for about 10-20 minutes. The last slide must contain references to both the literature (at least 3-4) and the regulatory sites (for example, EMA and / or FDA) that the working group considered for the preparation of the slides. 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 teaching lessons, will follow and can be taken on the same day as the thesis or on a subsequent day.
Both the oral exam and the thesis evaluation and the students' attendance at the course lessons (at least 60-70%) contribute to the final grade. The thesis has the greatest impact on the final grade. Typically the evaluation score for thesis, oral exam and attendance will be 50, 30 and 20% respectively. Based on teacher's opinion, if the thesis 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 a specific vocabulary.
For the thesis, students will have to form working groups (ideally 2-4 people, but if necessary also one or 5 people) and propose to and agree with the teacher a technical / technological topic related to the themes of the course program.
The thesis, which will last 40-60 minutes, will give each member of the working group the opportunity to speak for about 10-20 minutes. The last slide must contain references to both the literature (at least 3-4) and the regulatory sites (for example, EMA and / or FDA) that the working group considered for the preparation of the slides. 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 teaching lessons, will follow and can be taken on the same day as the thesis or on a subsequent day.
Both the oral exam and the thesis evaluation and the students' attendance at the course lessons (at least 60-70%) contribute to the final grade. The thesis has the greatest impact on the final grade. Typically the evaluation score for thesis, oral exam and attendance will be 50, 30 and 20% respectively. Based on teacher's opinion, if the thesis 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 a specific vocabulary.
Pharmaceutical production organization
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Lessons: 24 hours
Professor:
Palugan Luca
Technology processes and pharmaceutical regulatory affairs
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor:
Gennari Chiara Grazia Milena
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