Manufacturing of Biotechnological Drug Products
A.Y. 2020/2021
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 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
Teaching methods
Lessons can be followed on the basis of the first semester timetable in three different ways:
1) in attendance (about one third of the total hours of the course);
2) synchronously on the Microsoft Teams platform;
3) asynchronous: lessons will be recorded and left available to students on the Ariel platform. The recorded lessons will be made available to students on the ARIEL teaching platform throughout the semester and uploaded to the site according to the teaching schedule.
Program and reference material
The program and the reference material do not undergo variations.
Methods for verifying learning and evaluation criteria
If the situation does not allow the written exam to be taken, it will be replaced by an oral exam using the Microsoft Teams platform and it will consist of two questions on the topics covered during the teaching. The exam will be aimed at ascertaining the achievement of the objectives in terms of knowledge and verifying the student's independence of judgment.
The second part of the exam will in any case consist of an oral presentation, prepared by the students as indicated in the "Exam Methods" section. Also in this case the oral presentation will have the greatest impact on the final grade.
If the regulations concerning social distancing allow it, some formative evaluation activities will be held approximately halfway through the course. Participation in these activities will be voluntary and will have no impact on the final vote.
Lessons can be followed on the basis of the first semester timetable in three different ways:
1) in attendance (about one third of the total hours of the course);
2) synchronously on the Microsoft Teams platform;
3) asynchronous: lessons will be recorded and left available to students on the Ariel platform. The recorded lessons will be made available to students on the ARIEL teaching platform throughout the semester and uploaded to the site according to the teaching schedule.
Program and reference material
The program and the reference material do not undergo variations.
Methods for verifying learning and evaluation criteria
If the situation does not allow the written exam to be taken, it will be replaced by an oral exam using the Microsoft Teams platform and it will consist of two questions on the topics covered during the teaching. The exam will be aimed at ascertaining the achievement of the objectives in terms of knowledge and verifying the student's independence of judgment.
The second part of the exam will in any case consist of an oral presentation, prepared by the students as indicated in the "Exam Methods" section. Also in this case the oral presentation will have the greatest impact on the final grade.
If the regulations concerning social distancing allow it, some formative evaluation activities will be held approximately halfway through the course. Participation in these activities will be voluntary and will have no impact on the final vote.
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) 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.
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
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Lessons: 24 hours
Professor:
Adami Marco Oreste 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
Professor(s)
Reception:
to be arranged by email