nl en

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' 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 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.
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


In the second semester on Wednesdays.

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

  • Lectures

  • Tutorials

Assessment method

Written exam consisting of open questions.

A minimum of 5.5 or higher must be obtained in order to pass this course.

If a score lower than 5.5 is obtained, the student must perform an extra exam or assignment in consultation with the lecturers 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.


Registration must be done via MyStudyMap. Registration in MyStudyMap gives you automatic access to the course in Brightspace. For more information, please visit the Leiden University website for students.


Rawi Ramautar (Bio-Pharmaceutical Sciences)
Martin Pool (Farmacie)