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Pharmaceutical Biotechnology

Code 13666
Year 5
Semester S1
ECTS Credits 6
Workload PL(37H)/T(38H)
Scientific area Ciências Farmacêuticas
Entry requirements -
Mode of delivery Classroom teaching
Work placements Not applicable.
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
Syllabus Development of therapeutic products. Molecular Biotechnology. Physical, Chemical and Biochemical analysis of recombinant proteins. Technologies of production and Purification of Bioproducts. Unit operations of biotechnological processes. Production. Cell lysis. Chromatographic methods for the purification of bioproducts. Formulation, Pharmacokinetics, Pharmacodynamics and Immunogenicity. Main excipients and formulations used to stabilize proteins. General principles of pharmacokinetics and pharmacodynamics of biopharmaceuticals. Evaluation of immunogenicity. Regulatory and Bioethical criteria. Regulatory agencies. Regulatory and approval criteria. Globalization in Biotechnology. Main biotechnological products used as biopharmaceuticals. Oligonucleotides. Hematopoietic growth factors. Interferons and Interleukins. Insulin. Growth Hormones. Coagulation factors. Monoclonal Antibodies. Recombinant Human Deoxyribonuclease I. Follicle-Stimulating Hormone. Vaccines
Main Bibliography - Crommelin, DJA.; Sindelar, RD.; Meibohm B. Pharmaceutical Biotechnology – Fundamentals and Applications; 3rd Edition; Informa Healthcare; New York; 2008
- Walsh G. Biopharmaceuticals – Biochemistry and Biotechnology; 2nd Edition; Wiley; 2003
- Ho, RJY.; Gibaldi, M.; Biotechnology and Biopharmaceuticals; 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: 2021-02-09

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