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Design, analysis and practical use of biologicals


Admission requirements

Student is enrolled in the master Bio-Pharmaceutical Sciences or Pharmacy of Leiden University.


Most of the new drugs currently on the market are proteins or peptides. Knowledge about these drugs should not be lacking among Bio-Pharmaceutical Sciences and Pharmacy students. Moreover, knowledge about the development of new vaccines has also increased enormously in a very short time. The elective course 'Design, analysis and practical use of biologicals and vaccines' is intended for the master phase Bio-Pharmaceutical Sciences and Pharmacy. The students receive education in the development and use of biologicals and learn additional competences by working together. Education is also given in the development of vaccines and in particular about the stability of these newly developed products. The elective course is concluded with a video assignment that is worked out in groups of 3 to 5 students of Bio-Pharmaceutical Sciences and Pharmacy and with an individual written exam.

Course objectives

After completing this course, the student is able to:
1. explain the processes underlying the production of proteins and peptides.
2. assess the purity, safety and stability of proteins and peptides and to give an overview of the analytical toolbox for characterizing the biologicals (including a description of the underlying principals of the techniques).
3. explain the basic principles of vaccine production and analysis.
4. indicate how these innovative medicines should be used in practice and what advice you should give to patients and care providers for the correct application.
5. distinguish original biologicals from biosimilars and which regulations apply to the registration of these products
6. to show the design, analysis or practical use of a biological or vaccine via a video group assignment, taking into account the previous learning objectives


You will find the timetables for all courses and degree programmes of Leiden University in the tool MyTimetable (login). Any teaching activities that you have sucessfully registered for in MyStudyMap will automatically be displayed in MyTimeTable. Any timetables that you add manually, will be saved and automatically displayed the next time you sign in.

MyTimetable allows you to integrate your timetable with your calendar apps such as Outlook, Google Calendar, Apple Calendar and other calendar apps on your smartphone. Any timetable changes will be automatically synced with your calendar. If you wish, you can also receive an email notification of the change. You can turn notifications on in ‘Settings’ (after login).

For more information, watch the video or go the the 'help-page' in MyTimetable. Please note: Joint Degree students Leiden/Delft have to merge their two different timetables into one. This video explains how to do this.

Mode of instruction

Group assignment (setting up a YouTube movie)

Assessment method

The assessment consists of 2 parts:

  • Written exam consisting of open questions: 50%

  • Video assignment: 50%

A minimum of 5.0 or higher must be obtained for each part, whereby the average of both components must be at least 5.5 in order to pass this course.

If a score lower than 5.0 is obtained for one of the parts, the student must perform an extra exam or assignment in consultation with the coordinator and in accordance with the guidelines of the study programme.

Reading list

The following book is strongly suggested fort his course:
Daan J. A. Crommelin, Robert D. Sindelar, Bernd Meibohm (Eds.). Pharmaceutical Biotechnology. 5th ed. 2019. Hardcover ISBN 978-3-030-00709-6. Softcover ISBN 978-3-030-00711-9. eBook ISBN 978-3-030-00710-2

Additional peer-reviewed scientific literature (accessible via PubMed or university lbrary):
Daan J.A. Crommelina, Yvonne Bouwman-Boer. Pharmacy preparations: Back in the limelight? Pharmacists make up your mind!. Int J Pharm 514 (2016) 11–14.
Wim Jiskoot, M. Reza Nejadnik, Ahmad S. Sediq. Potential Issues With the Handling of Biologicals in a Hospital. Journal of Pharmaceutical Sciences 106 (2017) 1688-1689
Daan J.A. Crommelin, Thomas J. Anchordoquy, David B. Volkin, Wim Jiskoot, Enrico
Mastrobattista. Addressing the cold reality of mRNA vaccine stability.

Links to scientific literature focused on the characterization of biologicals will be provided at the start of the course.


From the academic year 2022-2023 on every student has to register for courses with the new enrollment tool MyStudyMap. There are two registration periods per year: registration for the fall semester opens in July and registration for the spring semester opens in December. Please see this page for more information.

Please note that it is compulsory to both preregister and confirm your participation for every exam and retake. Not being registered for a course means that you are not allowed to participate in the final exam of the course. Confirming your exam participation is possible until ten days before the exam.

Extensive FAQ's on MyStudymap can be found here. .


Rawi Ramautar (Bio-Pharmaceutical Sciences)


All other information.