Manufacturing of biotechnological drug products

A.Y. 2021/2022
Overall hours
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.
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.
Course syllabus and organization

Single session

Lesson period
First semester
More specific information on the delivery modes of training activities for academic year 2021/22 will be provided over the coming months, based on the evolution of the public health situation.
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.
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) 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. 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 made available in Ariel by the teacher.
Assessment methods and Criteria
The course exam consists of a written test and an oral presentation prepared by the students.
The written test consists of 5-6 multiple-choice questions and at least an open question on the topics covered in class.
As far as the oral presentation is concerned, the students will have to form working groups (ideally 2-4 team members, even 1 or 5 team members, if necessary) and propose to/agree with the teacher a technical/technological topic relevant to the themes of the course program.
The exam will begin with the written test, which the teacher will assess immediately afterwards. The oral presentation will follow. Its duration will be 40-60 minutes so to give each student the chance to speak for about 10-20 minutes. The last slide of the presentation must include the references to both the scientific literature papers (at least 3-4 papers) and the regulatory sites (e.g., EMA and/or FDA) considered for the elaboration of the slides. The presentation slides will preferably be in English. The lecture can be in Italian.
Both the assessment of the written test and the oral presentation and the attendance of the students to the course lessons (at least 60-70%) will contribute to the final grade. The oral presentation has the greates impact on the final grade. Typically, the evaluation score will be 50%, 30% and 20%, respectively. However, based on teacher's opinion, if the oral presentation is considered excellent, its evaluation score may increase.
Pharmaceutical production organization
Lessons: 24 hours
Professor: Palugan Luca
Technology processes and pharmaceutical regulatory affairs
Lessons: 32 hours