Code |
16868
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Year |
1
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Semester |
S2
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ECTS Credits |
5
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Workload |
TP(40H)
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Scientific area |
Biomedicina/Medicina/Bioquímica
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Entry requirements |
No requirements
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Learning outcomes |
Upon successful completion of this course, the student should be able to: -Describe the steps involved in the construction of a DNA vaccine and methodologies for its amplification/production on a small and large scale in the host cell -List the available methods for cell disintegration, clarification, isolation and purification of DNA vaccines. Understand the evolution of chromatographic supports and innovation of ligands that maximize the yield and purity of DNA vaccines -Apply methods of formulation and characterization of DNA vaccine delivery systems and evaluate their efficiency of complexation, protection, transport and delivery of the vaccine to the target cell. Describe conventional and innovative methods of vaccine administration -Identify good practices for obtaining a vaccine on a large scale and requirements of regulatory agencies, as well as stages of implementation and approval of clinical trials -Research and critically analyze scientific articles related to the course
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Syllabus |
Biosynthesis of DNA Vaccines A) Design and cloning B) Host cell transformation C) Small and large scale production/amplification: Biosynthesis in bioreactors.
Isolation and Purification of DNA Vaccines A) Cellular disruption, clarification and isolation methods: Membrane technology B) Purification methods, evolution of chromatographic supports and innovation of ligands for biorecognition of DNA vectors Delivery and Administration Systems A) Most explored formulation methods and materials for complexation, protection, transport and delivery of DNA vaccines to the target cell for antigen expression B) Conventional and innovative methods of vaccine administration: injection vs inhalation of liquid or powder Translation to Clinical Trials and Approval A) Implementation of Current Good Manufacturing Practices and regulatory agency requirements for clinical application B) Clinical trials: Ethical issues, and preparation and approval phases
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Main Bibliography |
1. Book: Ângela Sousa (ed.), (2021) “DNA Vaccines: Methods and Protocols”, Methods in Molecular Biology, vol. 2197, Springer Science+Business Media, LLC, part of Springer Nature (ISBN 978-1-0716-0872-2) https://doi.org/10.1007/978-1-0716-0872-2
2. Paper: D. Eusébio, A.R. Neves, D. osta, S. Biswas, G. Alves, Z. Cui, A. Sousa. 2021. Methods to improve the immunogenicity of plasmid DNA vaccines. Drug Discovery Today. 26: 2575-2592 DOI: 10.1016/j.drudis.2021.06.008 https://doi.org/10.1016/j.drudis.2021.06.008
3. Paper: D. Eusébio, M. Paul, S. Biswas, Z. Cui, D. Costa, A. Sousa*. 2024. Mannosylated polyethylenimine-cholesterol-based nanoparticles for targeted delivery of minicircle DNA vaccine against COVID-19 to antigen-presenting cells. International Journal of Pharmaceutics 654: 123959 DOI: 10.1016/j.ijpharm.2024.123959 https://doi.org/10.1016/j.ijpharm.2024.123959
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Teaching Methodologies and Assessment Criteria |
The activities carried out in this Advanced Course are primarily based on the active participation of students in tutorials for the specific presentation of the program content; seminars/workshops held by researchers/professors from research centers of excellence (national/international), with experience in the different areas under analysis (emphasizing the integration of bioprocesses to obtain vaccines on a large scale, measures inherent to good practices and consequent translation for the implementation and approval of clinical trials to be designed) The final grade of 0-20 will be obtained by the weighted average of the evaluation components: - Written test: 40% - Written work: 50% - Classroom attitudes: 10% UC approval depends on obtaining an average grade higher than 10 and attendance higher than 80%.
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Language |
Portuguese. Tutorial support is available in English.
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