| Code |
16820
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| Year |
1
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| Semester |
L0
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| ECTS Credits |
5
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| Workload |
OT(101H)/PL(10H)/T(30H)/TP(4H)
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| Scientific area |
Community Health
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Entry requirements |
1. Be at least 18 years old.
2. Be enroled or hold a bachelor's or master's degree in Health Sciences and related areas.
3. Professionals or researchers interested in developing nucleic acid vaccines.
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Learning outcomes |
Upon successfully finishing this curricular unit, the student must be able to:
-Describe the steps 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 of 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 for formulating and characterizing DNA vaccine delivery systems and evaluating their complexation, protection, transport and delivery efficiency of the vaccine to the target cell. Describe conventional and innovative vaccine administration methods
-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 themes
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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) Cell disintegration, clarification and isolation methods: Membrane technology
B) Purification methods, evolution of chromatographic supports and innovation of ligands for the biorecognition of DNA vectors
Delivery and Administration Systems
A) Formulation methods and most explored materials for the complexation, protection, transport and delivery of DNA vaccines to the target cell for antigen expression
B) Conventional and innovative vaccine administration methods: injection vs liquid or powder inhalation
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. Article: D. Eusébio, A.R. Neves, D. Costa, 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. Article: 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 dedicated to the specific presentation of the programme contents; seminars/workshops delivered by researchers/lecturers from centres of excellence (national and international) with experience in the different areas under analysis (emphasising the integration of bioprocesses for large-scale vaccine production, the measures inherent to good practices, and the subsequent translation towards the implementation and approval of the clinical trials to be designed).
The final grade (0–20) will be obtained from the weighted average of the assessment components:
Written test: 40%
Written assignment: 50%
Classroom attitudes/engagement: 10%
Approval in the course unit requires achieving a final average grade above 10 and an attendance rate above 80%.
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Language |
Portuguese. Tutorial support is available in English.
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