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Pharmaceutical Biotechnology

Code 12475
Year 1
Semester S1
ECTS Credits 6
Workload OT(30H)/PL(30H)
Scientific area Biotecnologia
Entry requirements -
Mode of delivery Classroom teaching
Work placements Not applicable.
Learning outcomes - To understand the concept of Biotechnology: the definition and the development of Biotechnology.
- To distinguish the main unit operations involved in a Biotechnological Process and to recognize the relevance of integration to develop new drug products.
- To understand the application of Biotechnology for the production of new biopharmaceutical products.
- To study the main biotechnological products used as pharmaceutical drugs.
- To know the main regulatory and ethical issues related to the development and approval of biotechnology-based products applied as pharmaceuticals.

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.
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
Main Bibliography - Crommelin, DJA.; Sindelar, RD.; Meibohm B. Pharmaceutical Biotechnology – Fundamentals and Applications; 3rd Edition; Informa Healthcare; New York; 2008
- Ho, RJY.; Gibaldi, M.; Biotechnology and Biopharmaceuticals; Wiley; 2003
- Walsh G. Biopharmaceuticals – Biochemistry and Biotechnology; 2nd Edition; Wiley; 2003
Teaching Methodologies and Assessment Criteria Teaching methods
Tutorial classes + workshops + training activities in the laboratory (experimental work) + exercises + case studies
Language Portuguese. Tutorial support is available in English.
Last updated on: 2020-05-20

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