Curricular Unit:			Code:
Pharmaceutical Industrial Biotechnology			843BIF
Year:	Level:	Course:	Credits:
4	Master	Pharmaceutical Sciences	4 ects
Learning Period:		Language of Instruction:	Total Hours:
Winter Semester		Portuguese/English	52
Learning Outcomes of the Curricular Unit:
The Pharmaceutical Industrial Biotechnology has the main objective of study the technological processes required for the production, manufacture and registration of biopharmaceuticals. The application of biotechnological methods in cell therapy and genetics, as well as knowledge of different types of biomaterials must also be addressed in the context of Pharmaceutical Biotechnology. At the end of the Curricular Unit (CU) students should: - Understand the concept of Biotechnology. - Distinguish the various application areas of Biotechnology, with special focus on the Pharmaceutical Industrial Biotechnology. - Identify several types of biopharmaceutical products, and their administration routes and delivery systems. - Acquire knowledge of cell and genetic therapy, genetic tests, pharmacogenetics and pharmacogenomics. - Have a global knowledge about the different classes of biomaterials used in medicine. - Know Biotechnology rules and ethics.
Syllabus:
Teaching Units 1 and 2: Lectures 1. Definition of Biotechnology 2. Main steps of the development of Biotechnology 3. Areas of application of Biotechnology 4. Fundamentals of molecular Biotechnology 5. Biopharmaceutical Products 6. Cell therapy 7. Cell encapsulation 8. Gene therapy 9. Genetic tests 10. Genomic 11. Biomaterials 12. Probiotics 13. Regulatory aspects and bioethics 14. Examples of Pharmaceutical Biotechnology Teaching Unit 3: Theoretical-practical lessons and Laboratory practices 1. Bibliographic research related with one of the areas of application of Pharmaceutical Biotechnology. 2. Oral presentation of the research work. 3. Preparation of alginate microparticles by extrusion/gelification 4. Preparation of vaginal suppositories with probiotics 5. Study of a bioreactor
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
Students should acquire knowledge of the processes involved in biotechnology. Emphasis should be given to the Pharmaceutical Biotechnology, notably with regard to all the steps involved in obtaining biopharmaceuticals. The students will also be encouraged to enlarge their knowledge of Pharmaceutical Biotechnology and its respective practical applications in various pharmaceutical systems through literature. Will be transmitted knowledge on the methods of preparation, assay and quality control of different pharmaceutical systems and their relation with the biopharmaceutical processes. It will also studied mode of operation of a bioreactor.
Teaching Methodologies (Including Evaluation):
The evaluation of the theoretical component comprises the execution of two written tests. The final classification will be calculated using the average of the results obtained in the two written tests (2 ECTS). The minimum passing classification is 9,5. For the student to be evaluated in the theoretical component, he must attend at 50% of classes. The evaluation of the laboratory component comprises: a continuous evaluation of the autonomous execution of laboratory work (30%); execution of a writing test (40%); oral presentation of a research work (30%). The minimum passing classification for the laboratory component is 9.5 (2 ECTS). For the student to be evaluated, he must attend at 80% of the laboratory classes. The final approval is obtained by the average (higher than 10) of the theoretical (80%) and laboratory (20%) components.
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
The lectures will be taught using the expository method of teaching and questioning. The syllabus of teaching units 1 and 2 will be presented in a descriptive manner, supported by slideshow. The theoretical-practical and laboratory classes will be taught using the method statement and execution of experimental work, related to the topics covered in lectures. The teacher will clarify the doubts and guide the student study. The evaluation of the Curricular Unit (CU) will be conducted in accordance with the general UFP pedagogical rules. The knowledge acquired by the student will be checked by evaluating the theoretical and the laboratory component of the CU. All activities with evaluative nature (ECTS) duly proportionate to the total number of credits will be awarded to the CU. The ECTS provided for work-study student will only be fully allocated or not, depending on the performance demonstrated by the student, in particular with respect to the acquisition of knowledge and skills covered by the CU.
Reading:
[1] Walsh, G., Pharmaceutical Biotechnology: Concepts and applications, 2007, ISBN 978-0-470-01244-4. [2] Gad, S.C. (Ed.), Handbook of Pharmaceutical Biotechnology, 2007, ISBN: 978-0-471-21386-4. [3] Klefenz, H., Industrial Pharmaceutical Biotechnology, 2005; ISBN 3-527-29995-5. [4] Crommelin, D., Sindelar, R., Meibohm, B., Pharmaceutical Biotechnology: Fundamentals and applications, 2007, ISBN 978-1420044379. [5] Kayser, O. and Müller, R.H., Pharmaceutical Biotechnology, Drug Discovery and Clinical Applications, 2004, ISBN 3-527-30554-8. [6] Lima, N. e Mota, M., Biotecnologia: Fundamentos e aplicações, Lidel Edições Técnicas, Lda, 2003, ISBN 9789727571970. [7] Sambamurthy, K. and Kar, A., Pharmaceutical Biotechnology, 2009, ISBN 978-81-224-2424-9. [8] Silva A.C., Sousa Lobo J.M., Cytokines and Growth Factors. In: Advances in Biochemical Engineering/Biotechnology. Springer, Berlin, Heidelberg, 2019, DOI: https://doi.org/10.1007/10_2019_105.