| Code |
13666
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| Year |
5
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| Semester |
S1
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| ECTS Credits |
6
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| Workload |
PL(37H)/T(38H)
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| Scientific area |
Ciências Farmacêuticas
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Entry requirements |
-
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Mode of delivery |
Classroom teaching
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Work placements |
Not applicable.
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Learning outcomes |
Students that complete this course should be able to identify and design the different unit operations involved in a global biotechnological process, considering the conditions needed for its application in the production of new biopharmaceuticals. Thus, the general aims are:
-To understand the Biotechnology concept and its application in biopharmaceuticals production
-To distinguish the Bioprocess operations to develop drugs
-To study some bioproducts used as pharmaceutical drugs
-To know the main regulatory and ethical issues for approval of biopharmaceuticals
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Syllabus |
1.Development of therapeutic products
1.1.Molecular Biotechnology
1.2.Physical, Chemical and Biochemical analysis of recombinant proteins
2.Technologies of Production and Purification of Bioproducts
2.1.Biotechnological unit operations characterization
2.2.Production
2.3.Cell lysis and recovery
2.4.Chromatography for bioproducts purification
3.Formulation and Pharmacology
3.1.Excipients and formulations
3.2.General principles of pharmacokinetics and pharmacodynamics of biopharmaceuticals
3.3.Immunogenicity
4.Regulatory and Bioethical criteria
4.1.Regulatory agencies
4.2.Regulatory and approval criteria
4.3.Globalization in Biotechnology
5.Main biopharmaceuticals (Oligonucleotides, Hematopoietic growth factors, Interferons and Interleukins, Insulin, Growth Hormones, Coagulation factors, Monoclonal Antibodies, Recombinant Human DNase I, Follicle-Stimulating Hormone, Vaccines)
EXPERIMENTAL WORK: Production, Recovery, Purification and Formulation of Plasmid DNA
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Main Bibliography |
- Crommelin, DJA.; Sindelar, RD.; Meibohm B. Pharmaceutical Biotechnology – Fundamentals and Applications; 5th Edition; Springer; 2019
- Walsh G. Biopharmaceuticals – Biochemistry and Biotechnology; 2nd Edition; Wiley; 2003
- Ho, RJY.; Gibaldi, M.; Biotechnology and Biopharmaceuticals; Wiley; 2003
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Teaching Methodologies and Assessment Criteria |
Teaching methods
Tutorial classes + workshops + training activities in the laboratory (experimental work) + exercises + case studies
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Language |
Portuguese. Tutorial support is available in English.
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