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.
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
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Mode of instruction
Group assignment (setting up a YouTube movie)
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.
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. https://doi.org/10.1016/j.xphs.2020.12.006
Links to scientific literature focused on the characterization of biologicals will be provided at the start of the course.
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Rawi Ramautar (Bio-Pharmaceutical Sciences)
All other information.